Impurity Markers for pharma industry
ADI-IMPM-01-00100 | Abacavir | API | (1S,4R)-4-[2-Amino-6(cyclopropylamino)-9H-purin-9-yl]-2cyclopentene-1-methanol | 25MG,50MG | Refregerator | 136470-78-5 | 286.33 | C14H18N6O | (1S-cis)-4-[2-Amino-6(cyclopropylamino)-9H-purin-9-yl]2-cyclopentene-1-methanol; 1592U89; ABC; | abacavir – API |
ADI-IMPM-01-00101 | Descyclopropyl Abacavir | IH | (1S,4R)-4-(2,6-Diamino-9H-purin-9-yl)-2cyclopentene-1-methanol; | 25MG,50MG | freeze | 124752-25-6 | 246.27 | C11H14N6O | Abacavir Related Compound A | Abacavir – In house impurity |
ADI-IMPM-01-00102 | (1S,4R)-4-(2-Amino-6-chloro-9H-purin-9- yl)-2-cyclopentene-1-methanol Hydrochloride | IH | (1S-cis)-4-(2-Amino-6-chloro-9H-purin-9- yl)-2-cyclopentene-1-methanol Monohydrochloride |
25MG,50MG | Refrigerator, Under Inert Atmosphere | 172015-79-1 | 302.16 | C11H13Cl2N5O | Abacavir Related Compound C; | Abacavir – In house impurity |
ADI-IMPM-01-00103 | trans-Abacavir Hydrochloride | IH | (1R,4R)-rel-4-[2-Amino-6- (cyclopropylamino)-9H-purin-9-yl]-2- cyclopentene-1-methanol Hydrochloride | 25MG,50MG | NA | 267668-71-3 | 322.79 | C11H13Cl2N5O | NA | Abacavir – In house impurity |
ADI-IMPM-01-00104 | Abacavir Sulfate | IH | (1S,4R)-4-[2-Amino-6- (cyclopropylamino)-9H-purin-9-yl]-2- cyclopentene-1-methanol Sulfate; Ziagen | 25MG,50MG | Freezer | 188062-50-2 | 670.47 | C28H38N12O6S | NA | Abacavir – In house impurity |
ADI-IMPM-01-00105 | Abacavir Carboxylate | IH | (1S,4R)-4-[2-Amino-6- (cyclopropylamino)-9H-purin-9-yl]-2- cyclopentene-1-carboxylic Acid; 2269W | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 384380-52-3 | 300.32 | C14H16N6O2 | NA | Abacavir – In house impurity |
ADI-IMPM-01-00106 | Abacavir 5’-β-D-Glucuronide | IH | [(1S,4R)-4-[2-amino-6- (cyclopropylamino)-9H-purin-9-yl]-2- cyclopenten-1-yl]methyl-β-DGlucopyranosiduronic Acid; Abacavir 5’- Glucuronide | 25MG,50MG | Freezer, Under Inert Atmosphere | 384329-76-4 | 462.46 | C20H26N6O7 | NA | Abacavir – In house impurity |
ADI-IMPM-01-00107 | Abacavir 5’-Phosphate | IH | (1S,4R)- 4-[2-Amino-6- (cyclopropylamino)-9H-purin-9-yl]-2- cyclopentene-1-methanol Dihydrogen Phosphate (Ester) | 25MG,50MG | Freezer | 136470-77-4 | 366.31 | C14H19N6O4P | (1S-cis)-Abacavir Monophosphate | Abacavir – In house impurity |
ADI-IMPM-01-00108 | Abacavir 5’-(2,3,4-Tri-O-isobytyryl)-β-Dglucuronic Acid Methyl Ester | IH | Glucuronic Acid Methyl Ester, Abacavir 5’-(2,3,4-Tri-O-isobytyryl)-β-D-; | 25MG,50MG | NA | NA | 686.75 | C33H46N6O10 | NA | Abacavir – In house impurity |
ADI-IMPM-01-00109 | (1S,4R)-4-(2-Amino-6-chloro-9H-purin-9- yl)-2-cyclopentene-1-carboxylate | IH | (1S-cis)-4-(2-Amino-6-chloro-9H-purin-9- yl)-2-cyclopentene-1-carboxylate | 25MG,50MG | NA | 1246819-78-2 | 279.68 | C11H10ClN5O2 | NA | Abacavir – In house impurity |
ADI-IMPM-01-00110 | (1S,4R)-cis-4-Amino-2-cyclopentene-1- methanol D-Tartrate | IH | (1S-cis)-4-Amino-2-cyclopentene-1- methanol D-Tartrate; | 25MG,50MG | Refrigerator | 229177-52-0 | 263.24 | C10H17NO7 | (1S,4R)-cis-4-Amino-2- cyclopentene-1-methanol (2S,3S)- 2,3-Dihydroxybutanedioate; | Abacavir – In house impurity |
ADI-IMPM-01-00111 | N-(2-Amino-4,6-dichloro-5- pyrimidinyl)formamide | IH | N-(2-Amino-4,6-dichloropyrimidin-5- yl)formamide; | 25MG,50MG | Amber Vial, Refrigerator, Under inert atmosphere | 171887-03-9 | 207.02 | C5H4Cl2N4O | NA | Abacavir – In house impurity |
ADI-IMPM-01-00112 | 0 rac 2-Azabicyclo[2.2.1]hept-5-en-3-one | IH | (+/-)-2-Azabicyclo[2.2.1]hept-5-en-3-one; (+/-)-Vince Lactam; Vince Lactam; | 25MG,50MG | Refrigerator | 49805-30-3 | 109.13 | C6H7NO | NA | Abacavir – In house impurity |
ADI-IMPM-01-00113 | (1R)-(-)-2-Azabicyclo[2.2.1]hept-5-en-3- one | IH | (1R,4S)-2-Azabicyclo[2.2.1]hept-5-en-3- one; (-)-2-Azabicyclo[2.2.1]hept-5-en-3- one; (-)-Vince Lactam; | 25MG,50MG | NA | 79200-56-9 | 109.13 | C6H7NO | NA | Abacavir – In house impurity |
ADI-IMPM-01-00114 | Carbovir Monophosphate | IH | rel-2-Amino-1,9-dihydro-9-[(1R,4S)-4- [(phosphonooxy)methyl]-2-cyclopenten-1- yl]-6H-purin-6-one; | 25MG,50MG | NA | 144490-73-3 | 327.23 | C11H14N5O5P | cis-(±)-2-Amino-1,9-dihydro-9-[4- [(phosphonooxy)methyl]-2- cyclopenten-1-yl]-6H-purin-6-one; Carbovir 5’-Phosphate; | Abacavir – In house impurity |
ADI-IMPM-01-00115 | Carbovir Triphosphate Triethylamine Salt | IH | rel-P-[[(1R,4S)-4-(2-Amino-1,6-dihydro-6- oxo-9H-purin-9-yl)-2-cyclopenten-1- yl]methyl] Ester Triphosphoric Acid Triethylamine Salt; | 25MG,50MG | Hygroscopic, -20°C Freezer, Under inert atmosphere | 1391048-07-9 | 487.19 | 11H16N5O11P3•xC6H1 | cis-(±)-P-[[4-(2-Amino-1,6-dihydro6-oxo-9H-purin-9-yl)-2-cyclopenten1-yl]methyl] Ester Triphosphoric Acid Triethylamine Salt; (±)- Carbovir Triphosphate Triethylamine Salt; |
Abacavir – In house impurity |
ADI-IMPM-01-00116 | (1S,4R)-4-[(2,5-Diamino-6-chloro-4- pyrimidinyl)amino]-2-cyclopentene-1- methanol | IH | (1S-cis)-4-[(2,5-Diamino-6-chloro-4- pyrimidinyl)amino]-2-cyclopentene-1- methanol; | 25MG,50MG | NA | 141271-11-6 | 255.7 | C10H14ClN5O | NA | Abacavir – In house impurity |
ADI-IMPM-01-00117 | Carbovir Triphosphate | IH | (+/-)-cis-2-Amino-1,9-dihydro-9-[4- oxymethyltriphosphate-2- cyclopenten-1-yl-]purine-6-one; Aids001909; Aids-001909; | 25MG,50MG | NA | 121864-74-2 | 487.19 | C11H16N5O11P3 | NA | Abacavir – In house impurity |
ADI-IMPM-01-00118 | PA 01 03010 | IH | (1R,2R,4S)-2-(2-Amino-6- (cyclopropylamino)-9H-purin-9-yl)-4- (hydroxymethyl)cyclopentanol; 4- (Hydroxymethyl)cyclopentanol, (1R,2R,4S)-2-(2-amino-6- (cyclopropylamino)-9H-purin-9-yl)-; | 25MG,50MG | NA | NA | 304.35 | C14H20N6O2 | NA | Abacavir – In house impurity |
ADI-IMPM-01-00119 | Cyclopropyldiaminopurine Abacavir | IH | N6-Cyclopropyl-9H-purine-2,6- diamine; 2-Amino-6- cyclopropylamino-9H-purine; N6- Cyxlopropyl-7H-purine-2,6- diaMine; 1H-Purine-2,6-diaMine, N6-cyclopropyl-; | 25MG,50MG | NA | 120503-69-7 | 190.21 | C8H10N6 | NA | Abacavir – In house impurity |
ADI-IMPM-01-00120 | Abamectin | API | Avermectin B1; MK-936; Agri-Mek; Avid; Zephyr; | 25MG,50MG | Freezer | 71751-41-2 | 873.08 | C48H72O14 | NA | Abietic Acid – API |
ADI-IMPM-01-00121 | Emamectin Benzoate | IH | 4”-Deoxy-4”-epi-N- (methylamino)avermectin B1 Benzoate; MK 244; | 25MG,50MG | Refrigerator | 155569-91-8 | 1008.24 | C56H81NO15 | Methylamino abamectin benzoate; Proclaim; Proclaim 5SG; Sch 58854; Shot-Wan; Slice; | Abacavir – In house impurity |
ADI-IMPM-01-00122 | Ivermectin | IH | 22,23-Dihydroavermectin B1; 22,23- Dihydro C-076B1; Heartgard 30; Ivomec; | 25MG,50MG | Freezer | 70288-86-7 | 875.09 | C48H74O14 | Ivosint; Mectizan; Stromectol; Uvemec; Vermic; Zimecterin; | Abacavir – In house impurity |
ADI-IMPM-01-00123 | Abietic Acid | API | (1R,4aR,4bR,10aR)- 1,2,3,4,4a,4b,5,6,10,10a-Decahydro1,4a-dimethyl-7-(1-methylethyl)-1- phenanthrenecarboxylic Acid; | 25MG,50MG | Refrigerator | 514-10-3 | 302.45 | C20H30O2 | 13-Isopropylpodocarpa-7,13-dien15-oic Acid; (-)-Abietic Acid; 7,13- Abietadien-18-oic Acid; Abietic Acid; NSC 25149; Odomit B 10; Sylvic Acid; ZAO; l-Abietic Acid; | Abietic Acid – API |
ADI-IMPM-01-00124 | Dehydroabietic Acid | IH | (1R,4aS,10aR)-1,2,3,4,4a,9,10,10aOctahydro-1,4a-dimethyl-7-(1- methylethyl)-1-phenanthrenecarboxylic Acid; | 25MG,50MG | Refrigerator | 1740-19-8 | 300.44 | C20H28O2 | 13-Isopropylpodocarpa-8,11,13- trien-15-oic Acid; (+)- Dehydroabietic acid; Abieta8,11,13-trien-18-oic acid; NSC 2952; [1R-(1α,4aβ,10aα)]- 1,2,3,4,4a,9,10,10a-octahydro1,4a-dimethyl-7-(1-methylethyl)-1- Phenanthrenecarboxylic Acid; | Abacavir – In house impurity |
ADI-IMPM-01-00125 | Dehydroabietinol | IH | (1R,4aS,10aR)-1,2,3,4,4a,9,10,10aOctahydro-1,4a-dimethyl-7-(1- methylethyl)-1-phenanthrenemethanol; | 25MG,50MG | NA | 3772-55-2 | 286.45 | C20H30O | 13-Isopropylpodocarpa-8,11,13- trien-15-ol; Dehydroabeityl Alcohol; Dehydroabietol; Dehydroabietyl alcohol; Pomiferin A; arAbietatrienol; [1R-(1α,4aβ,10aα)]- 1,2,3,4,4a,9,10,10a-Octahydro1,4a-dimethyl-7-(1-methylethyl)-1- phenanthrenemethanol; | Abacavir – In house impurity |
ADI-IMPM-01-00126 | Abiraterone | API | (3β)-17-(3-Pyridinyl)androsta-5,16-dien-3- ol; CB 7598; 17-(Pyridin-3-yl)androsta5,16-diene-3β-ol ; | 25MG,50MG | Refrigerator | 154229-19-3 | 349.51 | C24H31NO | NA | Abiraterone – API |
ADI-IMPM-01-00127 | Abiraterone Acetate | API | (3β)-17-(3-Pyridinyl)androsta-5,16-dien3-ol Acetate (Ester); CB 7630; | 25MG,50MG | Freezer | 154229-18-2 | 391.55 | C26H33NO2 | NA | Abiraterone Acetate – API |
ADI-IMPM-01-00128 | Abiraterone β-D-Glucuronide | IH | (3β)-17-(3-Pyridinyl)androsta-5,16-dien-3- ol β-D-Glucuronide; | 25MG,50MG | NA | NA | 525.63 | C30H39NO7 | NA | Abacavir – In house impurity |
ADI-IMPM-01-00129 | Abiraterone Sulfate Sodium Salt | IH | (3β)-17-(3-Pyridinyl)androsta-5,16-dien-3- ol Sulfate Sodium; | 25MG,50MG | NA | NA | 451.55 | C24H30NNaO4S | NA | Abacavir – In house impurity |
ADI-IMPM-01-00130 | Abiraterone N-Oxide Sulfate | IH | (3β)-17-(3-Pyridinyl)androsta-5,16-dien-3- ol N-Oxide Sulfate; | 25MG,50MG | NA | NA | 445.57 | C24H31NO5S | NA | Abacavir – In house impurity |
ADI-IMPM-01-00131 | (3β)-Androsta-5,16-diene-3,17-diol 3-Acetate 17- (Trifluoromethanesulfonate) | IH | [(3S,10R,13S)-10,13-Dimethyl-17- (trifluoromethylsulfonyloxy)- 2,3,4,7,8,9,11,12,14,15- decahydro-1Hcyclopenta[a]phenanthren-3-yl] Acetate; Prasterone Acetate Triflate; | 25MG,50MG | NA | 115375-60-5 | NA | C22H29F3O5S | 17- {[(Trifluoromethyl)sulfonyl]ox y}androsta-5,16-diene-3β-yl Acetate; |
Abacavir – In house impurity |
ADI-IMPM-01-00132 | Androsta-3,5,16-trien-17-ol Trifluoromethanesulfonate | IH | Androsta-3,5,16-trien-17-ol Trifluoro Methanesulfonate Discontinued; (8R,9S,10R,13S,14S)-10,13- Dimethyl2,7,8,9,10,11,12,13,14,15- decahydro-1H | 25MG,50MG | NA | 154229-36-4 | NA | C20H25F3O3S | NA | Abacavir – In house impurity |
ADI-IMPM-01-00133 | (5α)-17-(3-Pyridinyl)androst-16-en-3-one | IH | 16-en-3-one, (5α)-17-(3- Pyridinyl)androst-; (5S,8R,9S,10S,13S,14S)-10,13-Dimethyl17-(pyridin-3-yl)- 4,5,6,7,8,9,10,11,12,13,14,15- dodecahydro-1Hcyclopenta[a]phenanthren-3(2H)-one; | 25MG,50MG | NA | 154229-26-2 | 349.51 | C24H31NO | NA | Abacavir – In house impurity |
ADI-IMPM-01-00134 | α-Epoxyabiraterone Acetate | IH | (4S,6aR,6bS,8aS,8bR,9aR,10aS,10bR)- 6a,8a-Dimethyl-8b-(pyridin-3-yl)- 3,4,5,6,6a,6b,7,8,8a,8b,9a,10,10a,10btetradecahydro-1Hnaphtho[2′,1′:4,5]indeno[1,2-b]oxiren-4-yl Acetate; | 25MG,50MG | NA | NA | 407.55 | C26H33NO3 | NA | Abacavir – In house impurity |
ADI-IMPM-01-00135 | β-Epoxyabiraterone Acetate | IH | (4S,6aR,6bS,8aS,8bS,9aS,10aS,10bR)- 6a,8a-Dimethyl-8b-(pyridin-3-yl)- 3,4,5,6,6a,6b,7,8,8a,8b,9a,10,10a,10btetradecahydro-1Hnaphtho[2′,1′:4,5]indeno[1,2-b]oxiren-4-yl Acetate; | 25MG,50MG | NA | NA | 407.55 | C26H33NO3 | NA | Abacavir – In house impurity |
ADI-IMPM-01-00136 | Abiraterone Ethyl Ether | IH | 3-((3S,8R,9S,10R,13S,14S)-3-Ethoxy10,13-Dimethyl2,3,4,7,8,9,10,11,12,13,14,15- dodecahydro-1Hcyclopenta[a]phenanthren-17-yl)pyridine | 25MG,50MG | NA | NA | 377.56 | C26H35NO | NA | Abacavir – In house impurity |
ADI-IMPM-01-00137 | Abiraterone Isopropyl Ether | IH | 3-((3S,8R,9S,10R,13S,14S)-3- Isopropoxy-10,13-dimethyl2,3,4,7,8,9,10,11,12,13,14,15- dodecahydro-1Hcyclopenta[a]phenanthren-17-yl)pyridine; | 25MG,50MG | NA | NA | 391.59 | C27H37NO | NA | Abacavir – In house impurity |
ADI-IMPM-01-00138 | 7-Ketoabiraterone Acetate | IH | (3S,8R,9S,10R,13S,14S)-10,13- Dimethyl-7-oxo-17-(pyridin-3-yl)- 2,3,4,7,8,9,10,11,12,13,14,15- dodecahydro-1Hcyclopenta[a]phenanthren-3-yl Acetate; | 25MG,50MG | NA | NA | 405.53 | C26H31NO3 | 7-Keto Abiraterone Acetate; | Abacavir – In house impurity |
ADI-IMPM-01-00139 | Pregnenolone-16-ene Acetate | IH | 16-Dehydro Pregnenolone Acetate; (3β)- 3-(Acetyloxy)pregna-5,16-dien-20-one; 3β-Hydroxypregna-5,16-dien-20-one Acetate; (-)-16-Dehydropregnenolone Acetate; 16,17-Didehydropregnenolone Acetate; | 25MG,50MG | Refrigerator | 979-02-2 | 356.5 | C23H32O3 | 16-DPA; 16-Dehydropregnenolone3β-acetate; 20-Oxopregna-5,16- dien-3β-yl Acetate; 3βAcetoxypregna-5,16-dien-20-one; 3β-Acetyloxy-pregna-5,16-dien-20- one; NSC 37741; Pregnadienolone Acetate; | Abacavir – In house impurity |
ADI-IMPM-01-00140 | 0 3β-(4-Chlorobutoxy)-17-(pyridin-3- yl) androsta-5,16-diene | IH | Abiraterone Related Compound 8; 3-((3S,8R,9S,10R,13S,14S)-3- (4-Chlorobutoxy)-10,13-dimethyl2,3,4,7,8,9,10,11,12,13,14,15- dodecahydro-1Hcyclopenta[a]phenanthren-17- yl)pyridine; | 25MG,50MG | NA | NA | 440.06 | C28H38ClNO | NA | Abacavir – In house impurity |
ADI-IMPM-01-00141 | Anhydro Abiraterone | IH | 17-(Pyridin-3-yl)androsta-3,5,16-triene; 3- Androsta-3,5,16-trien-17-yl-pyridine; 3- ((8R,9S,10R,13S,14S)-10,13-Dimethyl2,7,8,9,10,11,12,13,14,15-decahydro-1Hcyclopenta[a]phenanthren-17-yl)pyridine | 25MG,50MG | NA | 154229-20-6 | 331.49 | C24H29N | NA | Abacavir – In house impurity |
ADI-IMPM-01-00142 | 3-Deoxy 3-Chloro Abiraterone | IH | 3β-Chloro-17-(pyridin-3-yl) androsta-5,16- diene; 3-((8R,9S,10R,13S,14S)-3-Chloro10,13-dimethyl2,3,4,7,8,9,10,11,12,13,14,15- dodecahydro-1Hcyclopenta[a]phenanthren-17-yl)pyridine | 25MG,50MG | NA | NA | 367.95 | C24H30ClN | NA | Abacavir – In house impurity |
ADI-IMPM-01-00143 | 3-Deoxy-3-acetylabiraterone-3-ene | IH | 1-[17-( Pyridin-3-yl)androsta-3,5,16-trien3-yl]ethanone; 1-((8R,9S,10R,13S,14S)- 10,13-Dimethyl-17-(pyridin-3-yl)- 2,7,8,9,10,11,12,13,14,15-decahydro-1Hcyclopenta[a]phenanthren-3-yl)ethanone; | 25MG,50MG | NA | NA | 373.53 | C26H31NO | NA | Abacavir – In house impurity |
ADI-IMPM-01-00144 | Prasterone Triflate | IH | 3β-Hydroxyandrosta-5,16-diene-17-yl trifluoromethanesulfonate; | 25MG,50MG | NA | 124643-35-2 | 420.49 | C20H27F3O4S | NA | Abacavir – In house impurity |
ADI-IMPM-01-00145 | Prasteronyl Abiraterone | IH | 3β-(Androst-5-ene-17-one-3βyloxy)-17-(3-pyridinyl)androsta5,16-diene; | 25MG,50MG | Freezer | NA | 619.92 | C43H57NO2 | (3R,8R,9S,10R,13S,14S)-3- (((3S,8R,9S,10R,13S,14S)- 10,13-Dimethyl-17-(pyridin-3- yl)- 2,3,4,7,8,9,10,11,12,13,14,1 5-dodecahydro-1Hcyclopenta[a]phenanthren-3- yl)oxy)-10,13-dimethyl |
Abacavir – In house impurity |
ADI-IMPM-01-00146 | Acacetin | API | 2-(4-Methoxyphenyl)-5,7-dihydroxy-4H-1- benzopyran-4-one; 4′-O-Methylapigenin | 25MG,50MG | NA | 154229-26-2 | 284.26 | C16H12O5 | 5,7-Dihydroxy-4′-methoxyflavone; LY 064233; Linarigenin; NSC 76061 | Acacetin – API |
ADI-IMPM-01-00147 | Acacetin 7-O-β-D-Galactopyranoside | IH | 7-(β-D-Galactopyranosyloxy)-5-hydroxy2-(4-methoxyphenyl)-4H-1-benzopyran-4- one; | 25MG,50MG | NA | 80443-15-8 | 446.4 | C22H22O10 | NA | Abacavir – In house impurity |
ADI-IMPM-01-00148 | 3-p-Anisoyl Acacetin | IH | 5,7-Dihydroxy-3-(4-methoxybenzoyl)-2- (4-methoxyphenyl)-4H-1-benzopyran-4- one; | 25MG,50MG | Freezer | 874519-13-8 | 418.4 | C24H18O7 | NA | Abacavir – In house impurity |
ADI-IMPM-01-00149 | Acadesine | API | 5-Aminoimidazole-4-carboxamide-1-β-Dribofuranoside; | 25MG,50MG | Freezer | 2627-69-2 | 258.23 | C9H14N4O5 | AICAR; Acadesine; 5-Amino-1-βD-ribofuranosyl-1H-imidazole-4- carboxamide; 5-Amino-4-imidazole carboxamide Riboside; Arasine; GP 1-110; NSC 105823; | Acadesine – API |
ADI-IMPM-01-00150 | Acamprosate Calcium | API | 3-(Acetylamino)-1-propanesulfonic Acid Calcium Salt; Alcomed; Aotal; Ca-AOTA; Calcium N-Acetylhomotaurinate; | 25MG,50MG | Freezer | 77337-73-6 | 400.48 | C10H20CaN2O8S2 | Calcium Acamprosate; Calcium Bisacetyl Homotaurine; Campral EC; Sobriol; | Acamprosate Calcium – API |
ADI-IMPM-01-00151 | Homotaurine | IMP A | 3-Amino-1-propanesulfonic Acid; 3- Aminopropiosulfonic Acid; 3- Sulfopropylamine; Alzhemed; | 25MG,50MG | Freezer | 3687-18-1 | 139.17 | C3H9NO3S | NC 758; NSC 77071; Tramiprosate; | Acamprosate Calcium – Impurity A |
ADI-IMPM-01-00152 | Calcium Bis(formyl Homotaurine) | IH | Calcium 3-Formamidopropane-1- sulfonate; | 25MG,50MG | NA | NA | 372.43 | C8H16CaN2O8S2 | NA | Acamprosate Calcium – In house impurity |
ADI-IMPM-01-00153 | Acarbose | API | O-4,6-Dideoxy-4-[[(1S,4R,5S,6S)-4,5,6- trihydroxy-3-(hydroxymethyl)-2- cyclohexen-1-yl]amino]-α-Dglucopyranosyl-(1→4)-O-α-Dglucopyranosyl-(1→4)-D-glucose; |
25MG,50MG | Hygroscopic , Freezer, Under Inert Atmosphere | 56180-94-0 | 645.6 | C25H43NO18 | Arcabose; Ascarbose; BAY-g 5421; Glucobay; Prandase; Precose; | Acarbose – API |
ADI-IMPM-01-00154 | Acarbose D-Fructose Impurity | IMP A | O-4,6-Dideoxy-4-[[(1S,4R,5S,6S)-4,5,6- trihydroxy-3-(hydroxymethyl)cyclohex-2- enyl]amino]-α-Dglucopyranosyl-(1→4)-Oα-D-glucopyranosyl-(1→4)-Darabino-hex2-ulopyranose; | 25MG,50MG | Freezer | 1013621-79-8 | 645.6 | C25H43NO18 | O-4,6-Dideoxy-4-[[(1S,4R,5S,6S)- 4,5,6-trihydroxy-3-(hydroxymethyl)- 2-cyclohexen-1-yl]amino]-a-Dglucopyranosyl-(1?4)-O-a-Dglucopyranosyl-(1?4)-D-fructose; | Acarbose – Impurity A |
ADI-IMPM-01-00155 | (1R,4R,5S,6R)-4,5,6-Trihydroxy-2- (hydroxymethyl)cyclohex-2-enyl 4- O-[4,6- dideoxy-4-[[(1S,4R,5S,6S)- 4,5,6-trihydroxy-3- (hydroxymethyl)cyclohex-2- enyl]amino]-α-D-glucopyranosyl]-αD-glucopyranoside | IMP A | (1S,2S,3R,6S)-6- (((2R,3S,4S,5R,6R)-6- (((2R,3S,4R,5R,6S)-4,5- Dihydroxy-2-(hydroxymethyl)-6- (((1R,4R,5S,6R)-4,5,6-trihydroxy2-(hydroxymethyl)cyclohex-2-en1-yl)oxy)tetrahydro-2H-pyran-3- yl)oxy)-4,5-dihydroxy-2- |
25MG,50MG | NA | NA | 641.62 | C26H43NO17 | NA | Acarbose – Impurity B |
ADI-IMPM-01-00156 | α-D-glucopyranosyl 4-O-[4,6 dideoxy-4-[[(1S,4R,5S,6S)-4,5,6- trihydroxy-3- (hydroxymethyl)cyclohex-2- enyl]amino]-a-D-glucopyranosyl]-αD-glucopyranoside |
IMP C | ((2R,3R,4R,5S,6R)-5- (((2R,3R,4S,5S,6R)-3,4- Dihydroxy-6-methyl-5- (((1S,4R,5S,6S)-4,5,6-trihydroxy3-(hydroxymethyl)cyclohex-2-en1-yl)amino)tetrahydro-2H-pyran-2- yl)oxy)-3,4-dihydroxy-6- (hydroxymethyl)tetrahydro-2H | 25MG,50MG | NA | NA | 645.6 | C25H43NO18 | NA | Acarbose – Impurity C |
ADI-IMPM-01-00157 | 4-O-[4,6-dideoxy-4- [[(1S,4R,5S,6S)-4,5,6-trihydroxy-3- (hydroxymethyl)cyclohex-2- enyl]amino]-α-D-glucopyranosyl]-Dglucopyranose | Imp D | (3R,4R,5S,6R)-5- (((2R,3R,4S,5S,6R)-3,4- Dihydroxy-6-methyl-5- (((1S,4R,5S,6S)-4,5,6-trihydroxy3-(hydroxymethyl)cyclohex-2-en1-yl)amino)tetrahydro-2H-pyran-2- yl)oxy)-6- | 25MG,50MG | NA | NA | 483.46 | C19H33NO13 | NA | Acarbose – Impurity D |
ADI-IMPM-01-00158 | 4-O-α-acarbosyl-D-fructopyranose | Imp E | O-4,6-Dideoxy-4-[[(1S,4R,5S,6S)- 4,5,6-trihydroxy-3- (hydroxymethyl)cyclohex-2- enyl]amino]-α-D-glucopyranosylO-α-D-glucopyranosyl-O-α-Dglucopyranosyl-D-arabino-hex-2- ulopyranose; (2R,3R,4S,5S,6R)-2- (((3S,4R,5R)-4- (((2R,3R,4S,5S,6R)-3,4- Dihydroxy-6-methyl-5- (((1S,4R,5S,6S)-4,5,6-trihydroxy3-(hydroxymethyl)cyclohex-2-en1-yl)amino)tetrahydro-2H-pyran-2 |
25MG,50MG | NA | NA | 807.75 | C31H53NO23 | NA | Acarbose – Impurity E |
ADI-IMPM-01-00159 | 4-O-α-acarbosyl-D-glucopyranose | Imp F | O-4,6-Dideoxy-4-[[(1S,4R,5S,6S)- 4,5,6-trihydroxy-3- (hydroxymethyl)cyclohex-2- enyl]amino]-α-D-glucopyranosylO-α-D-glucopyranosyl-O-α-Dglucopyranosyl-D-glucopyranose; (2R,2’R,3S,3’S,4S,4’S,5R,5’R,6R, 6’R)-6,6′-(((3R,4S,5R,6R)-4- (((2R,3R,4S,5S,6R)-3,4- dihydroxy-6-methyl-5- (((1S,4R,5S,6S)-4,5,6-trihydroxy3-(hydroxymethyl)cyclohex-2-en |
25MG,50MG | NA | NA | 807.25 | C31H53NO23 | NA | Acarbose – Impurity F |
ADI-IMPM-01-00160 | (α-D-glucopyranosyl α-acarboside | Imp G | α-D-Glucopyranosyl O-4,6- dideoxy-4-[[(1S,4R,5S,6S)-4,5,6- trihydroxy-3- (hydroxymethyl)cyclohex-2- enyl]amino]-a-D-glucopyranosylO-α-D-glucopyranosyl-O-α-Dglucopyranoside; | 25MG,50MG | NA | NA | 807.75 | C31H53NO23 | NA | Acarbose – Impurity G |
ADI-IMPM-01-00161 | O-4,6-Dideoxy-4-[[(1S,4R,5S,6S)- 4,5,6-trihydroxy-3- (hydroxymethyl)cyclohex-2- enyl]amino]-α-D-glucopyranosyl- (1→4)-O-6-deoxy-α-Dglucopyranosyl-(1→4)-D |
Imp H | NA | 25MG,50MG | NA | NA | 629.6 | C25H43NO17 | NA | Acarbose – Impurity H |
ADI-IMPM-01-00162 | Acebrophylline | API | Ambroxol Theophylline-7-Acetic Acid | 25MG,50MG | NA | 179118-73-1 | 616.3 | C22H28Br2N6O5 | NA | Acebrophylline – AP |
ADI-IMPM-01-00163 | Acebutolol Hydrochloride | API | N-[3-Acetyl-4-[2-hydroxy-3-[(1- methylethyl)amino]propoxy]phenyl]butan amide Hydrochloride; |
25MG,50MG | Freezer | 34381-68-5 | 372.89 | C18H29ClN2O4 | DL-1-(2-Acetyl-4-butyramido)-3- (isopropylamino)propan-2-ol Hydrochloride; IL-17803A; Acecor; Acetanol; Neptal; Prent; Sectral; | Acebutolol Hydrochloride – API |
ADI-IMPM-01-00164 | 3′-Acetyl-4′-(2,3- epoxypropoxy)butyranilide | Imp A | N-[3-Acetyl-4- (oxiranylmethoxy)phenyl]butanamide; | 25MG,50MG | NA | 28197-66-2 | 277.32 | C15H19NO4 | NA | Acebutolol – Impurity A |
ADI-IMPM-01-00165 | N-[3-Acetyl-4-(2-hydroxy-3- isopropylamino-propoxy)-phenyl]- acetamide Hydrochloride | Imp B | N-[3-Acetyl-4-[(2RS)-2-hydroxy-3-[(1- methylethyl) amino] propoxy] phenyl] acetamide; Diacetolol Hydrochloride; | 25MG,50MG | NA | 73899-76-0 | 344.83 | C16H25ClN2O4 | (1)-N-(3-Acetyl-4-(2-hydroxy-3-((1- methylethyl)amino)propoxy)phenyl )acetamide monohydrochloride; | Acebutolol – Impurity B |
ADI-IMPM-01-00166 | 0 N-(3-Acetyl-4-hydroxy-phenyl)-butyramide | IMP C | 2-Acetyl-4-butyramidophenol; | 25MG,50MG | NA | 40188-45-2 | 221.25 | C12H15NO3 | 3′-Acetyl-4′-hydroxybutyranilide; N- (3-Acetyl-4- hydroxyphenyl)butanamide; N-(3- Acetyl-4- hydroxyphenyl)butyramide; | Acebutolol – Impurity C |
ADI-IMPM-01-00167 | 1-(5-Amino-2-(2-hydroxy-3- (isopropylamino)propoxy)phenyl)ethanone | Imp D | 1-[5-amino-2-[(2RS)-2-hydroxy-3-[(1- methylethyl)amino]propoxy]phenyl]ethan one; | 25MG,50MG | NA | 57898-80-3 | 266.34 | C14H22N2O3 | NA | Acebutolol – Impurity D |
ADI-IMPM-01-00168 | N-(4-(2-Hydroxy-3- (isopropylamino)propoxy)phenyl)butyrami de Hydrochloride | Imp E | N-[4-[(2RS)-2-Hydroxy-3-[(1- methylethyl)amino]propoxy]phenyl]butan amide Hydrochloride; | 25MG,50MG | NA | NA | 330.85 | C16H27ClN2O3 | NA | Acebutolol – Impurity E |
ADI-IMPM-01-00169 | rac Des(isopropylamino) Acebutolol Diol | Imp F | N-[3-Acetyl-4-[(2RS)-2,3- dihydroxypropoxy]phenyl]butanamide; (+/-)-N-[3-Acetyl-4-(2,3- dihydroxypropoxy)phenyl]butanamide; | 25MG,50MG | NA | 96480-91-0 | 295.33 | C15H21NO5 | NA | Acebutolol – Impurity F |
ADI-IMPM-01-00170 | Acebutolol Dimer Impurity | Imp G | N,N’-[[(1-Methylethyl)imino]-bis[(2- hydroxypropane-1,3-diyl)oxy(3-acetyl-1,4- phenylene)]]dibutanamide; | 25MG,50MG | NA | NA | 613.74 | C33H47N3O8 | NA | Acebutolol – Impurity G |
ADI-IMPM-01-00171 | N,N’-[(2-Hydroxypropane-1,3- diyl)bis[oxy(3-acetyl-1,4- phenylene)]]dibutanamide | Imp H | [(2-Hydroxypropane-1,3-diyl)bis[oxy(3- acetyl-1,4-phenylene)]]dibutanamide, N,N’- |
25MG,50MG | NA | NA | 498.57 | C27H34N2O7 | NA | Acebutolol – Impurity H |
ADI-IMPM-01-00172 | N-[3-Acetyl-4-(3-ethylamino-2-hydroxypropoxy)-phenyl]-butyramide | Imp I | N-[3-Acetyl-4-[(2RS)-3-(ethylamino)-2- hydroxypropoxy]phenyl]butanamide; | 25MG,50MG | NA | 441019-91-6 | 322.4 | C17H26N2O4 | NA | Acebutolol – Impurity I |
ADI-IMPM-01-00173 | N-(3-Acetyl-4-(2-hydroxy-3- (isopropylamino)propoxy)phenyl)propiona mide Hydrochloride | Imp J | N-[3-Acetyl-4-[(2RS)-2-hydroxy-3-[(1- methylethyl) amino] propoxy] phenyl] propanamide Hydrochloride; | 25MG,50MG | NA | NA | 358.86 | C17H27ClN2O4 | NA | Acebutolol – Impurity J |
ADI-IMPM-01-00174 | N-[3-Butyryl-4-(3-ethylamino-2-hydroxypropoxy)-phenyl]-butyramide | Imp K | N-[3-Butanoyl-4-[(2RS)-2-hydroxy-3-[(1- methylethyl)amino]propoxy]phenyl]butan amide Hydrochloride; N-(3-Butyryl-4-(2- hydroxy-3- (isopropylamino)propoxy)phenyl)butyram ide Hydrochloride; | 25MG,50MG | NA | 57898-71-2 | 400.94 | C20H33ClN2O4 | rac 3-Deacetyl-3-butanoyl Acebutolol Hydrochloride; (+/-)-N- [4-[2-Hydroxy-3-[(1- methylethyl)amino]propoxy]-3-(1- oxobutyl)phenyl]butanamide Hydrochloride; | Acebutolol – Impurity K |
ADI-IMPM-01-00175 | Aceclofenac | API | Aceclofenac (WS); 2-[(2,6- Dichlorophenyl)-amino]benzeneacetic Acid Carboxymethyl Ester; | 25MG,50MG | Freezer | 89796-99-6 | 354.18 | C16H13Cl2NO4 | Glycolic Acid [o-(2,6- Dichloroanilino)phenyl]acetate Ester; PR-82/3; Airtal; Aceclofar; Falcol; Gerbin; Preservex; Tresquim; Zerodol; | Aceclofenac – API |
ADI-IMPM-01-00176 | Diclofenac Sodium | Imp A | 2-((2,6- Dichlorophenyl)aminobenzeneacetic Acid; [o-(2,6- Dichloroanilino)phenyl]acetic Acid Monosodium Salt; | 25MG,50MG | Freezer | 15307-79-6 | 318.13 | C14H10Cl2NNaO2 | Sodium Diclofenac; Sorelmon; Tsudohmin; Valetan; Voldal; Voltaren; Voltaren Ophtha; Benfofen; Delphimix; Diacron; Naclof; Naclofen; Neriodin; Novapirina; Orthofen; Orthophen; | Aceclofenac – Impurity A |
ADI-IMPM-01-00177 | Diclofenac Methyl Ester | Imp B | 2-[(2,6- Dichlorophenyl)amino]benzeneacetic Acid Methyl Ester | 25MG,50MG | Freezer | 15307-78-5 | 310.18 | C15H13Cl2NO2 | [o-(2,6- Dichloroanilino)phenyl]acetic Acid Methyl Ester; Methyl 2-(2,6- Dichloroanilino)phenylacetate; | Aceclofenac – Impurity B |
ADI-IMPM-01-00178 | Diclofenac Ethyl Ester | IMP C | 2-[(2,6- Dichlorophenyl)amino]benzeneacetic Acid Ethyl Ester; | 25MG,50MG | Freezer | 15307-77-4 | 324.2 | C16H15Cl2NO2 | [o-(2,6- Dichloroanilino)phenyl]acetic Acid Ethyl Ester; Ethyl 2-(2,6- Dichloroanilino)phenylacetate; | Aceclofenac – Impurity C |
ADI-IMPM-01-00179 | Aceclofenac Methyl Ester | Imp D | 2-[(2,6- Dichlorophenyl)amino]benzeneacetic Acid 2-Methoxy-2-oxoethyl Ester; | 25MG,50MG | Refrigerator | 139272-66-5 | 368.21 | C17H15Cl2NO4 | NA | Aceclofenac – Impurity D |
ADI-IMPM-01-00180 | Aceclofenac Ethyl Este | Imp E | Ethyl[[[2-[2,6-Dichloropehnyl)amino)phenyl]acetyl]oxy)-acetate; | 25MG,50MG | freezer | 139272-67-6 | 382.24 | C18H17Cl2NO4 | 2-[(2,6- Dichlorophenyl)amino]benzeneace tic Acid 2-Ethoxy-2-oxoethyl Ester; | Aceclofenac – Impurity E |
ADI-IMPM-01-00181 | Aceclofenac Benzyl Ester | Imp F | 2-[(2,6- Dichlorophenyl)amino]benzeneacetic Acid 2-Oxo-2-(phenylmethoxy)ethyl Ester; | 25MG,50MG | Refrigerator | 100499-89-6 | 444.31 | C23H19Cl2NO4 | NA | Aceclofenac – Impurity F |
ADI-IMPM-01-00182 | Acetic Aceclofenac | Imp G | [[[[[2-(2,6-Dichlorophenyl) amino]phenyl]acetyl] loxy]acetic Acid; | 25MG,50MG | NA | 1215709-75-3 | 412.22 | C18H15Cl2NO6 | 2-[(2,6- Dichlorophenyl)amino]benzeneace tic Acid 2-(Carboxymethoxy)-2- oxoethyl Ester; | Aceclofenac – Impurity G |
ADI-IMPM-01-00183 | Diacetic Aceclofenac | Imp H | [[[[[[[2-[(2,6- Dichlorophenyl)amino]phenyl]acetyl]oxy] acetyl]oxy]acetyl]oxy]acetic Acid; | 25MG,50MG | NA | 1216495-92-9 | 470.26 | C20H17Cl2NO8 | 2-[(2,6- Dichlorophenyl)amino]benzeneace tic Acid 2-[2-(Carboxymethoxy)-2- oxoethoxy]-2-oxoethyl Ester; | Aceclofenac – Impurity H |
ADI-IMPM-01-00184 | Diclofenac Amide | Imp I | Diclofenac Lactam; 1-(2,6- Dichlorophenyl)-1,3-dihydro-2H-indol-2- one; | 25MG,50MG | Refrigerator | 15362-40-0 | 278.13 | C14H9Cl2NO | 1-(2,6-Dichlorophenyl)oxindole; N- (2,6-dichlorophenyl)-2-indolinone; NSC 621845; Diclofenac Impurity A; | Aceclofenac – Impurity I |
ADI-IMPM-01-00185 | Aceclofenac Acyl-β-D-glucuronide | IH | 2-[(2,6-Dichlorophenyl)- amino]benzeneacetic Acid Carboxymethyl Ester Acyl-β-DGlucuronide; | 25MG,50MG | NA | NA | 530.31 | C22H21Cl2NO10 | NA | Aceclofenac – In house impurity |
ADI-IMPM-01-00186 | Acedoben | API | 4-(Acetylamino)benzoic Acid; 4- Acetamidobenzoic Acid | 25MG,50MG | Refrigerator | 556-08-1 | 179.17 | C9H9NO3 | 4′-Carboxyacetanilide; N-Acetyl-paminobenzoic Acid; NSC 4002; p- (Acetoamino)benzoic Acid | Acedoben – API |
ADI-IMPM-01-00187 | 4-Acetamido Antipyrine | IH | N-(2,3-Dihydro-1,5-dimethyl-3-oxo-2- phenyl-1H-pyrazol-4-yl)acetamide; | 25MG,50MG | freezer | 83-15-8 | 245.28 | C13H15N3O2 | 4-(N-Acetylamino)antipyrine; 4- Acetylaminophenazone; Acetylaminoantipyrine; N-Acetyl-4- aminoantipyrine; N-Acetyl-4- aminophenazone; NAntipyrinylacetamide; NSC 331807; | Acedoben – In house impurity |
ADI-IMPM-01-00188 | Acetaminophen Dimer | IH | N,N’-(6,6′-Dihydroxy[1,1′-biphenyl]-3,3′- diyl)bisacetamide; Paracetamol Dimer Impurity; | 25MG,50MG | Refrigerator | 98966-14-4 | 300.31 | C16H16N2O4 | NA | Acedoben – In house impurity |
ADI-IMPM-01-00189 | Acemetacin | API | 1-(4-Chlorobenzoyl)-5-methoxy-2-methyl1H-indole-3-acetic Acid Carboxymethyl Ester; | 25MG,50MG | room temp | 53164-05-9 | 415.82 | C21H18ClNO6 | TV-1322; Acemix; Emflex; Rantudil; Solart; | Acemetacin – API |
ADI-IMPM-01-00190 | 4-Chlorobenzoic Acid | Imp A | p-Chlorobenzoic Acid; 4-CBA; Mycosid; NSC 143358; NSC 32738; | 25MG,50MG | Refrigerator | 74-11-3 | 156.57 | C7H5ClO2 | NSC 8444; pCarboxychlorobenzene; pChlorbenzoic Acid; pChlorobenzoic Acid; | Acemetacin – Impurity A |
ADI-IMPM-01-00191 | Acephylline | API | Theophylline-7-acetic Acid; 1,2,3,6- Tetrahydro-1,3-dimethyl-2,6-dioxo-7Hpurine-7-acetic Acid; | 25MG,50MG | NA | 652-37-9 | 238.2 | C9H10N4O4 | 7-(Carboxymethyl)theophylline; 7- Theophyllineacetic Acid; 7- Theophyllinylacetic Acid; Acefylline; Acephylline; Carboxymethyltheophylline; N-7- Theophyllineacetic Acid; NSC 52996; Theophyllineacetic Acid | Acephylline – API |
ADI-IMPM-01-00192 | Acephylline Piperazine | IH | Piperazine Bis(2-(1,3-dimethyl2,6-dioxo-2,3-dihydro-1H-purin7(6H)-yl)acetate); | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 18833-13-1 | 562.54 | C22H30N10O8 | NA | Acephylline – In house impurity |
ADI-IMPM-01-00193 | Acesulfame Potassium | API | 6-Methyl-1,2,3-oxathiazin-4(3H)-one 2,2- Dioxide Potassium Salt; | 25MG,50MG | NA | 55589-62-3 | 201.24 | C4H4KNO4S | E 950; Otizon; Potassium Acesulfame; Sunett; Sunnett; 6- Methyl-3,4-dihydro-1,2,3- oxathiazin-4-one 2,2-Dioxide Potassium Salt; | Acesulfame Potassium – API |
ADI-IMPM-01-00194 | Acetoacetamide | Imp A | 3-Oxobutanamide; 3-Oxobutyramide; | 25MG,50MG | NA | 5977-14-0 | 101.1 | C4H7NO2 | Acetoacetic acid amide; NSC 632231; α-Acetylacetamide; Acetylacetamide; | Acesulfame Potassium – Impurity A |
ADI-IMPM-01-00195 | 5-Chloro Acesulfame | Imp B | 5-Chloro-6-methyl-1,2,3-Oxathiazin4(3H)-one 2,2-Dioxide; | 25MG,50MG | NA | 72827-08-8 | 197.6 | C4H4ClNO4S | NA | Acesulfame Potassium – Impurity B |
ADI-IMPM-01-00196 | Acetamidine Hydrochloride | API | Ethanimidamide Hydrochloride; Acediamine Hydrochloride; | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 124-42-5 | 94.54 | C2H7ClN2 | Acetamidinium Chloride; Methylamidine Hydrochloride; | Acetamidine Hydrochloride – AP |
ADI-IMPM-01-00197 | N-Benzoylcarbonylaminoacetamidine Hydrochloride | IH | Benzyl [Amidinomethyl]carbamate Hydrochloride; N-(2-Amino-2- iminoethyl)carbamic Acid Phenylmethyl Ester Hydrochloride; | 25MG,50MG | Room Temp | 50850-19-6 | 243.69 | C10H14ClN3O2 | NA | Acetamidine Hydrochloride – In house impurity |
ADI-IMPM-01-00198 | Acetaminophen | API | N-(4-Hydroxyphenyl)acetamide; | 25MG,50MG | NA | 103-90-2 | 151.16 | C8H9NO2 | 4’-Hydroxyacetanilide; 4- Acetamidophenol; N-Acetyl-4- aminophenol; APAP; Acamol; Acenol; Paracetamol; Paracetamole; Parageniol; | Acetaminophen – AP |
ADI-IMPM-01-00199 | 4-Acetaminophen Sulfate | IH | N-[4-(Sulfooxy)phenyl]acetamide; NAcetyl-p-aminophenyl Sulfate; Acetaminophen Sulfate; | 25MG,50MG | Hygroscop ic, Freezer, Under Inert Atmosphe re | 10066-90-7 | NA | C8H9NO5S | 4-Hydroxyacetanilide Sulfate; PCMS; Paracetamol O-Sulfate; Paracetamol Sulfate; | Acetaminophen – In house impurity |
ADI-IMPM-01-00200 | Acetaminophen Glutathione Disodium Salt | IH | L-γ-Glutamyl-S-[5-(acetylamino)- 2-hydroxyphenyl]-Lcysteinylglycine Disodium Salt; 3- (Glutathion-S-yl)acetaminophen Disodium Salt; 3- Glutathionylacetaminophen Disodium; Acetaminophen | 25MG,50MG | Hygroscopic, Refrigerator, Under inert atmosphere | NA | 500.43 | C18H22N4Na2O8 S | NA | Acetaminophen – In house impurity |
ADI-IMPM-01-00201 | Acetazolamide | API | N-[5-Aminosulfonyl)-1,3,4-thiadiazol-2- yl]acetamide; 5-Acetamido-1,3,4- thiadiazole-2-sulfonamide; Acetamox; | 25MG,50MG | NA | 59-66-5 | 222.25 | C4H6N4O3S2 | Atenezol; Defiltran; Diamox; Didoc; | Acetazolamide – API |
ADI-IMPM-01-00202 | 2-Acetamido-5-chloro-1,3,4-thiadiazole | Imp A | N-(5-Chloro-1,3,4-thiadiazol-2- yl)acetamide; 2-(Acetylamino)-5-chloro1,3,4-thiadiazole; | 25MG,50MG | NA | 60320-32-3 | 177.61 | C4H4ClN3OS | 2-Amino-5-acetamido-1,3,4- thiadiazole; NSC 231656; | Acetazolamide – Impurity A |
ADI-IMPM-01-00203 | 2-Acetamido-1,3,4-thiadiazole | Imp B | N-1,3,4-Thiadiazol-2-ylacetamide; 2- Acetamido-1,3,4-thiadiazole; | 25MG,50MG | Refrigerator | 5393-55-5 | 143.17 | C4H5N3OS | 2-Acetylamino-1,3,4-thiadiazole; NSC 4729; | Acetazolamide – Impurity B |
ADI-IMPM-01-00204 | N-(5-Sulfanyl-1,3,4-thiadiazol-2- yl)acetamide | IMP C | 2-Acetamido-5-mercapto-1,3,4- thiadiazole; N-(4,5-Dihydro-5-thioxo1,3,4-thiadiazol-2-yl)acetamide; | 25MG,50MG | Refrigerator | 32873-56-6 | 175.23 | C4H5N3OS2 | N-(5-Mercapto-1,3,4-thiadiazol-2- yl)acetamide; 2-Acetylamino-1,3,4- thiadiazoline-2-thione; NSC 97893 | Acetazolamide – Impurity C |
ADI-IMPM-01-00205 | 5-Amino-1,3,4-thiadiazole-2-sulfonamide | Imp D | 2-Amino-1,3,4-thiadazole-5-sulfonamide; L 5343; Tio-urasin; | 25MG,50MG | NA | 14949-00-9 | 180.21 | C2H4N4O2S2 | NA | Acetazolamide – Impurity D |
ADI-IMPM-01-00206 | 5-(Acetylamino)-1,3,4-thiadiazole-2- sulfonic Acid | Imp E | 2-(Acetylamino)-5-sulfo-1,3,4- thiadiazole; 4-Acetylamino-cyclopenta1,3-dienesulfonic acid | 25MG,50MG | NA | 827026-60-8 | 223.23 | C4H5N3O4S2 | NA | Acetazolamide – Impurity E |
ADI-IMPM-01-00207 | Bis[5-(acetylamino)-1,3,4-thiadiazole-2- sulfonyl]amine | Imp F | N,N’-[Iminobis(sulfonyl-1,3,4-thiadiazole5,2-diyl)]bisacetamide; | 25MG,50MG | Room Temp | 80495-47-2 | 427.46 | C8H9N7O6S4 | NA | Acetazolamide – Impurity F |
ADI-IMPM-01-00208 | 5-Amino-1,3,4-thiadiazole-2-thiol | Imp G | 2-Amino-1,3,4-thiadiazol-5-thiol; 2-Amino1,3,4-thiadiazole-5-mercaptan; 2-Amino1,3,4-thiadiazole-5-thiol; 2-Amino-5- mercapto-1,3,4-thiadiazole; 2-Amino-5- mercapto-1,3,5-thiadiazole; 2-Amino-5- mercaptothiadiazole; 2-Amino-Δ2-1,3,4 | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 2349-67-9 | 133.2 | C2H3N3S2 | 2-Mercapto-5-amino-1,3,4- thiadiazole; 2-Thiol-5-amino-1,3,4- thiadiazole; 5-Amino-1,3,4- thiadiazole-2(3H)-thione; 5-Amino1,3,4-thiadiazole-2-thiol; 5-Amino1,3,4-thiadiazole-2-thione; 5- | Acetazolamide – Impurity G |
ADI-IMPM-01-00209 | Acetohydroxamic Acid | API | N-Hydroxyacetamide; ethanehydroxamic Acid; AHA; Acetic Acid Oxime; Acetohydroximic Acid; Acetylhydroxamic Acid | 25MG,50MG | Refrigerato | 546-88-3 | 75.07 | C2H5NO2 | Acetylhydroxylamine; Methylhydroxamic Acid; NAcetylhydroxylamine; NHydroxyacetamide; NSC 176136 | Acetohydroxamic Acid – API |
ADI-IMPM-01-00210 | Acetone | API | Methyl Ketone; Dimethyl Ketone; Dimethylformaldehyde; | 25MG,50MG | NA | 67-64-1 | 58.08 | C3H6O | NSC 135802; Propanone; Pyroacetic Ether; Taimax; βKetopropane; Propan-2-one; | Acetone – API |
ADI-IMPM-01-00211 | Methanol | Imp A | Bieleski’s Solution; Carbinol; Methanol Cluster; Methyl Alcohol; Methyl | 25MG,50MG | Room Temp | 67-56-1 | 32.04 | CH4O | Methylol; Monohydroxymethane; NSC 85232; Wood Alcohol; | Acetone – Impurity A |
ADI-IMPM-01-00212 | Isopropanol | Imp B | 2-Propanol; Isopropyl Alcohol; 1- Methylethanol; 1-Methylethyl Alcohol; 2- Hydroxypropane; 2-Propyl Alcohol; Alcojel; Alcosolve 2; Autosept; Avantin; Avantine; Combi-Schutz; Dimethylcarbinol; | 25MG,50MG | NA | 67-63-0 | 60.1 | C3H8O | Hartosol; IPA; IPS 1; IPS 1 (Alcohol); Imsol A; Isohol; Isopropanol; Lutosol; NSC 135801; PRO; Petrohol; Propol; Steri-Fab; Sterisol Hand Disinfectant; Takineocol; Tokuso | Acetone – Impurity B |
ADI-IMPM-01-00213 | Benzene | IMP C | 1,3,5-Cyclohexatriene; Benzol; Benzole; Coal naphtha; Cyclohexatriene; | 25MG,50MG | Hygroscop ic, Refrigerat or, under | 71-43-2 | 78.11 | C6H6 | NSC 67315; Phene; Phenyl hydride; Pyrobenzol; Pyrobenzol | Acetone – Impurity C |
ADI-IMPM-01-00214 | Chloroacetone | IH | Acetonyl Chloride; Chloro-2- propanone; 1-Chloroacetone; Chloromethyl Methyl Ketone; Chloropropanone; | 25MG,50MG | Refrigerato | 78-95-5 | 92.52 | C3H5ClO | Methyl Chloromethyl Ketone; Monochloroacetone; | Acetone – In house impurity |
ADI-IMPM-01-00215 | Acetoxyprogesterone | API | 17α-Acetoxyprogesterone; Progesterone Acetate; 17-(Acetyloxy)pregn-4-ene-3,20- dione; 17-Hydroxypregn-4-ene-3,20- dione Acetate; 17- (Acetyloxy)progesterone; 17- Acetoxypregn-4-ene-3,20-dione; 17- Acetoxy-progesterone; | 25MG,50MG | NA | 302-23-8 | 372.5 | C23H32O4 | 17-Hydroxyprogesterone Acetate; 17α-Acetoxypregn-4-ene-3,20- dione; Hydroxyprogesterone Acetate; NSC 12191; U 5533; Melengestrol Acetate Related Compound A; Chlormadinone Acetate Impurity G | Acetoxyprogesteron e – API |
ADI-IMPM-01-00216 | 6-Keto-17α-acetoxy Progesterone | IH | (8R,9S,10R,13S,14S,17S)-17-Acetyl10,13-dimethyl-3,6-dioxo2,3,6,7,8,9,10,11,12,13,14,15,16,17- tetradecahydro-1Hcyclopenta[a]phenanthren-17-yl Acetate | 25MG,50MG | Refrigerato | NA | 386.48 | C23H30O5 | NA | Acetoxyprogesterone – In house impurity |
ADI-IMPM-01-00217 | Acetylcholine Chloride | API | 2-(Acetyloxy)-N,N,N,- trimethylethanaminium Chloride; Acecoline; Arterocoline; Miochol; Ovisot; | 25MG,50MG | NA | 60-31-1 | 181.66 | C7H16ClNO2 | NA | Acetylcholine Chloride – API |
ADI-IMPM-01-00218 | Choline Chloride | Imp A | 2-Hydroxy-N,N,N-trimethylethanaminium Chloride; (2- Hydroxyethyl)trimethylammonium Chloride; | 25MG,50MG | NA | 67-48-1 | 139.62 | C5H14ClNO | NA | Acetylcholine Chloride – Impurity A |
ADI-IMPM-01-00219 | 2-(Acetyloxy)-N,N-dimethylethanaminium Chloride | Imp B | 2-Acetoxy-N,N-dimethylethanaminium Chloride; | 25MG,50MG | NA | NA | 167.63 | C6H14ClNO2 | NA | Acetylcholine Chloride – Impurity B |
ADI-IMPM-01-00220 | Trimethylamine | IMP C | N,N-Dimethylmethanamine; NTrimethylamine; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 75-50-3 | 59.11 | C3H9N | NA | Acetylcholine Chloride – Impurity C |
ADI-IMPM-01-00221 | Acetylcysteine | API | N-Acetyl-L-cysteine; ACC; Acetadote; | 25MG,50MG | Refrigerator | 616-91-1 | 163.19 | C5H9NO3S | Acetilcysteina; Acetylcysteine; Airbron; Broncholysin; Brunac; Exomuc; Fabrol; Fluatox; Fluibiotic; Fluimicil; Fluimicil Infantil; N.alpha.-Acetylcysteine; Parvolex; Respaire; Syntemucol; | Acetylcysteine – API |
ADI-IMPM-01-00222 | L-Cystine | Imp A | (-)-Cystine; 3,3′-Dithiobis(2- aminopropanoic Acid); Bis(β-amino-βcarboxyethyl) Disulfide; Cystine Αcid; Dicysteine; 3,3′-Dithiobis-L-Alanine; LCysteine Disulfide; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 56-89-3 | 240.3 | C6H12N2O4S2 | L-Cystin; NSC 13203; Oxidized Lcysteine; [R-(R*,R*)]-3,3′-Dithiobis [2-aminopropanoic Acid]; l-Cystine; β,β’-Diamino-β,β’-dicarboxydiethyl Disulfide; β,β’-Dithiodialanine; | Acetylcysteine – Impurity A |
ADI-IMPM-01-00223 | L-Cysteine | Imp B | (R)-2-Amino-3-mercaptopropanoic Acid; (R)-Cysteine; 2-Amino-3- mercaptopropionic Acid; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 52-90-4 | 121.16 | C3H7NO2S | Cystein; Cysteine; E 920; Halfcystine; L-(+)-Cysteine; 3- Mercapto-L-alanine; L-Cys; NSC 8746; Thioserine; βMercaptoalanine; H-Cys-O | Acetylcysteine – Impurity B |
ADI-IMPM-01-00224 | N,N’-Diacetyl-L-cystine | IMP C | 2-Acetylamino-4-(2-acetylamino-2- carboxy-ethyldisulfanyl)-butyric acid; (AcCys-OH)2; | 25MG,50MG | Refrigerator | 5545-17-5 | 324.37 | C10H16N2O6S2 | N,N’-Diacetylcystine; NSC 203780; | Acetylcysteine – Impurity C |
ADI-IMPM-01-00225 | N,S-Diacetyl-L-Cysteine | Imp D | N-Acetylcysteine Acetate; Dacisteine; N,S-Diacetylcysteine; N-Acetylcysteine SAcetate; | 25MG,50MG | Hygroscopic , Freezer, Under Inert Atmosphere | 18725-37-6 | 205.23 | C7H11NO4S | NA | Acetylcysteine – Impurity D |
ADI-IMPM-01-00226 | N-Acetyl-S-propyl-L-cysteine | IH | N-Acetyl-3-(propylthio)alanine; Propylmercapturic Acid; | 25MG,50MG | NA | 14402-54-1 | 205.27 | C8H15NO3S | NA | Acetylcysteine – In house impurity |
ADI-IMPM-01-00227 | N-Acetyl-S-(2-acetylaminoethyl)-Lcysteine | IH | L-3-[(2-Acetamidoethyl)thio]-Nacetylalanine; | 25MG,50MG | Refrigerator | 25515-72-4 | 248.3 | C9H16N2O4S | NA | Acetylcysteine – In house impurity |
ADI-IMPM-01-00228 | N-Acetyl-S-(2-carboxyethyl)-L-cysteine Bis(dicyclohexylamine) Salt | IH | N-Acetyl-3-(2-carboxyethylthio)alanine Bis(dicyclohexylamine) Salt; 3-(N-AcetylL-cystein-S-yl)propanoic Acid Bisdicyclohexylamine) Salt; | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 51868-61-2 | 597.9 | C32H59N3O5S | N-Acetyl-S-(2- carboxyethyl)cysteine Bis(dicyclohexylamine) Salt; CEMA; | Acetylcysteine – In house impurity |
ADI-IMPM-01-00229 | N-Acetyl-β-alanine N-Hydroxysuccinimide Ester | IH | N-[3-[(2,5-Dioxo-1-pyrrolidinyl)oxy]-3- oxopropyl]acetamide; | 25MG,50MG | Freezer | 154194-69-1 | 228.2 | C9H12N2O5 | NA | Acetylcysteine – In house impurity |
ADI-IMPM-01-00230 | N-Acetyl-S-allyl-L-cysteine | IH | N-Acetyl-S-2-propen-1-yl-L-cysteine; LN-Acetyl-3-(allylthio)alanine; Allylmercapturic Acid; S-Allylmercapturic Acid; | 25MG,50MG | Freezer | 23127-41-5 | 203.26 | C8H13NO3S | NA | Acetylsalicylic Acid – API |
ADI-IMPM-01-00231 | Acetylsalicylic Acid | API | 2-Acetoxybenzoic Acid; 2- (Acetyloxy)benzoic Acid; Acylpyrin; Angettes; Aspro; Aspirin; ASA; | 25MG,50MG | Refrigerator | 50-78-2 | 180.16 | C9H8O4 | NA | Acetylsalicylic Acid – Impurity A |
ADI-IMPM-01-00232 | p-Salicylic Acid | Imp A | 4-Hydroxybenzoic Acid; 4- Hydroxybenzoic Acid; 4-Carboxyphenol; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 99-96-7 | 138.12 | C7H6O3 | Paraben-acid; p-Carboxyphenol; pHydroxybenzoic Acid; NSC 4961; Aspirin impurity A; | Acetylsalicylic Acid – Impurity B |
ADI-IMPM-01-00233 | 4-Hydroxyisophthalic Acid | Imp B | 4-Hydroxybenzene-1,3-dicarboxylicacid; 4-Hydroxy-1,3-benzenedicarboxylic Acid; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 636-46-4 | 182.13 | C8H6O5 | 4-Hydroxy-m-phthalic Acid; Eupirina; NSC 2445; Aspirin impurity B | Acetylsalicylic Acid – Impurity C |
ADI-IMPM-01-00234 | Salicylic Acid | IMP C | 2-Hydroxybenzoic Acid; 2- Carboxyphenol; 2- Hydroxybenzenecarboxylic Acid; 2- Hydroxybenzoic Acid; o-Carboxyphenol | 25MG,50MG | Refrigerator | 69-72-7 | 138.12 | C7H6O3 | o-Hydroxybenzoic Acid; Rutranex; Saligel; Salonil; Salvona Nanosal; Stri-Dex; Trans-Ver-Sal; Verrugon; Aspirin impurity C; | Acetylsalicylic Acid – Impurity D |
ADI-IMPM-01-00235 | Acetylsalicylsalicylic Acid | Imp D | 2-(Acetyloxy)benzoic Acid 2- Carboxyphenyl Ester; Acesalum; Diplosal Acetate; | 25MG,50MG | Refrigerator | 530-75-6 | 300.26 | C16H12O6 | Diplosalacetat; Salicylacetylsalicylic Acid; Aspirin impurity D; | Acetylsalicylic Acid – Impurity E |
ADI-IMPM-01-00236 | Salicylsalicylic Acid | Imp E | 2-Hydroxybenzoic Acid 2-Carboxyphenyl Ester; Salicylic Acid Salicylate; 2-((2- Hydroxybenzoyl)oxy)benzoic Acid; Diacesal; Diplosal; Disalcid; Disalgesic; Disalicylic Acid; Salicyl Salicylate; Salicyloxysalicylic Acid; | 25MG,50MG | Freezer, Under Inert Atmosphere | 552-94-3 | 258.23 | C14H10O5 | Disalyl; Mono-Gesic; NSC 49171; Nobacid; Salflex; Salical; Salicyloylsalicylic Acid; Salicylsalicylic Acid; Salina; Salsalate; Salysal; Sasapirin; Sasapyrine; Sasapyrinum; o | Acetylsalicylic Acid – Impurity F |
ADI-IMPM-01-00237 | Acetylsalicylic Anhydride | Imp F | 2-(Acetyloxy)benzoic Anhydride; Salicylic Acid Acetate Anhydride; 2- Acetoxybenzoic Anhydride; | 25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphere | 1466-82-6 | 342.3 | C18H14O7 | Aspirin anhydride; Contraflu; NSC 63848; NSC 80056; Pircan; Vigal; 2-(Acetyloxy)benzoic Acid 1,1’- Anhydride; Aspirin impurity F; | Acitretin – API |
ADI-IMPM-01-00238 | Acitretin | API | (all-E)-9-(4-Methoxy-2,3,6- trimethylphenyl)-3,7-dimethyl-2,4,6,8- nonatetraenoic Acid; Neotigason; | 25MG,50MG | Amber Vial, Freezer | 55079-83-9 | 326.43 | C21H26O3 | Soriatane; 9-(4-Methoxy-2,3,6- trimethylphenyl)-3,7-dimethylnona2,4,6,8-tetraenoic acid; | Acitretin – Impurity A |
ADI-IMPM-01-00239 | 13-cis Acitretin | Imp A | (2Z,4E,6E,8E)-9-(4-Methoxy-2,3,6- trimethylphenyl)-3,7-dimethyl-2,4,6,8- nonatetraenoic acid; 13-cis-Etretin; Isoacitretin; Isoetretin; Ro 13-7652; | 25MG,50MG | Amber Vial, Freezer, Under inert atmosphere | 69427-46-9 | 326.43 | C21H26O3 | (2Z,4E,6E,8E)-9-(4-methoxy-2,3,6- trimethylphenyl)-3,7- dimethylnona2,4,6,8-tetraenoic acid; Acitretin Related Compound A; | Acitretin – In house impurity |
ADI-IMPM-01-00240 | 9-cis Acitretin | IH | (2E,4E,6Z,8E)-9-(4-Methoxy-2,3,6- trimethylphenyl)-3,7-dimethyl-2,4,6,8- nonatetraenoic Acid; | 25MG,50MG | Refrigerato | 419534-31-9 | 326.43 | C21H26O3 | NA | Acridine – API |
ADI-IMPM-01-00241 | Acridine | API | 10-Azaanthracene; 2,3-Benzoquinoline; | 25MG,50MG | Refrigerato | 260-94-6 | 179.22 | C13H9N | 9-Azaanthracene; Benzo[b]quinoline; Dibenzo[b,e]pyridine; NSC 3408; | Acridine – In house impurity |
ADI-IMPM-01-00242 | 9-Acridinecarboxylic Acid Hydrate | IH | NSC 386 Hydrate; Acridine-9-carboxylic Acid Hydrate; | 25MG,50MG | Amber Vial, Refrigerat or | 332927-03-4 | 223.23 | C14H9NO2•xH2O | NA | Acriflavine Hydrochloride – API |
ADI-IMPM-01-00243 | Acriflavine Hydrochloride | API | 3,6-Diamino-10-methylacridinium Chloride Dihydrochloride; Acriflavine Dihydrochloride; Acriflavinium Chloride; Flavacridine Hydrochloride; | 25MG,50MG | Amber Vial, Freezer, Under inert atmospher e | 8063-24-9 | 541.9 | C27H27Cl3N6 | NA | Acrivastine – API |
ADI-IMPM-01-00244 | Acrivastine | API | (2E)-3-[6-[(1E)-1-(4- Methylphenyl)-3-(1-pyrrolidinyl)-1- propen-1-yl]-2-pyridinyl]-2- propenoic Acid; Semprex; (E,E)-3- [6-[1-(4-Methylphenyl)-3-(1- pyrrolidinyl)-1-propenyl]-2- pyridinyl]-2-propenoic Acid; | 25MG,50MG | Freezer | 87848-99-5 | 348.44 | C22H24N2O2 | (2E)-3-[6-[1-(4- Methylphenyl)-3-(1- pyrrolidinyl)-1-propenyl]-2- pyridinyl]-2-propenoic Acid; | |
ADI-IMPM-01-00245 | Acyclovir | API | 2-Amino-1,9-dihydro-9-[(2- hydroxyethoxy)methyl]-6H-purin-6-one; Aciclovir; | 25MG,50MG | Refrigerator | 59277-89-3 | 225.2 | C8H11N5O3 | 9-[(2- Hydroxyethoxy)methyl]guanine; Acycloguanosine; Acicloftal; Cargosil; Gerpevir; Herpevir; Zovirax; Zyclir; | Acyclovir – API |
ADI-IMPM-01-00246 | Acyclovir Acetate | Imp A | Acetic acid 2-(2-amino-6-oxo-1,6-dihydropurin-9-ylmethoxy)-ethyl ester; Aciclovir Acetate; | 25MG,50MG | Refrigerator | 102728-64-3 | 267.24 | C10H13N5O4 | 9-(2- Acetoxyethoxymethyl)guanine; 9- [[2-(Acetyloxy)ethoxy]methyl]-2- amino-1,9-dihydro-6H-purin-6-one; Acyclovir Related Compound A; Aciclovir Impurity A; | Acyclovir – Impurity A |
ADI-IMPM-01-00247 | Guanine | Imp B | 2-Amino-1,9-dihydro-6H-purin-6-one; 2- Amino-hypoxanthine; 2-Amino-1,9- dihydro-6H-purin-6-one; | 25MG,50MG | NA | 73-40-5 | 151.13 | C5H5N5O | 2-Amino-6-hydroxy-1H-purine; 2- Amino-6-hydroxypurine; 2- Aminohypoxanthine; 9H-Guanine; Ganciclovir Impurity F; Aciclovir Impurity B; | Acyclovir – Impurity B |
ADI-IMPM-01-00248 | 2-Amino-1,7-dihydro-7-[(2- hydroxyethoxy)methyl]-6H-purin-6-one | IMP C | 2-Amino-7-(2-hydroxy-ethoxymethyl)-1,7- dihydro-purin-6-one; | 25MG,50MG | NA | 91702-61-3 | 225.2 | C8H11N5O3 | 2-Amino-1,7-dihydro-7-[(2- hydroxyethoxy)methyl]-6H-purin-6- one; Aciclovir Impurity C; | Acyclovir – Impurity C |
ADI-IMPM-01-00249 | N2-Acetyl Acyclovir | Imp F | N-[6,9-Dihydro-9-[(2- hydroxyethoxy)methyl]-6-oxo-1H-purin-2- yl]acetamide; 9-[(2- Hydroxyethoxy)methyl]-N2- acetylguanine; N2-Acetyl Aciclovir; | 25MG,50MG | Refrigerator | 110104-37-5 | 267.24 | C10H13N5O4 | Aciclovir Impurity F; | Acyclovir – Impurity F |
ADI-IMPM-01-00250 | Acyclovir N,O-Diacetate | Imp G | N-[9-[[2-(Acetyloxy)ethoxy]methyl]-6,9- dihydro-6-oxo-1H-purin-2-yl]acetamide; 9-[(2-Acetoxyethoxy)methyl]-N2- acetylguanine; Diacetyl Acyclovir; Aciclovir N,O-Diacetate; | 25MG,50MG | NA | 75128-73-3 | 309.28 | C12H15N5O5 | N2-Acetyl-9-(2- acetoxyethoxymethyl)guanine; Aciclovir Impurity G; | Acyclovir – Impurity G |
ADI-IMPM-01-00251 | O-[(Guanin-7-yl)methyl] Acyclovir | Imp I | 9,7’-[1,2- Ethanediylbis(oxymethylene)]bisguanine; O-[(Guanin-7-yl)methyl] Aciclovir; | 25MG,50MG | NA | 1797832-75-7 | 388.34 | C14H16N10O4 | Aciclovir Impurity I; | Acyclovir – Impurity I |
ADI-IMPM-01-00252 | O-[(Guanin-9-yl)methyl] Acyclovir | Imp j | 9,9′-[1,2- Ethanediylbis(oxymethylene)]bisguanine; O-[(Guanin-9-yl)methyl] Aciclovir; | 25MG,50MG | NA | 166762-90-9 | 388.34 | C14H16N10O4 | 9,9’-[1,2- Ethanediylbis(oxymethylene)]bis[2- amino-1,9-dihydro-6H-purin-6- one]; Aciclovir Impurity J; | Acyclovir – Impurity J |
ADI-IMPM-01-00253 | Acyclovir N-Methylene Dimer | Imp K | 2,2’-(Methylenediimino)bis[9-[(2- hydroxyethoxy)methyl]-1,9-dihydro-6Hpurin-6-one]; Aciclovir N-Methylene Dimer; | 25MG,50MG | NA | 1797131-64-6 | 462.42 | C17H22N10O6 | Aciclovir Impurity K; | Acyclovir – Impurity K |
ADI-IMPM-01-00254 | N2,9-diacetylguanine | Imp L | N-(9-Acetyl-6,9-dihydro-6-oxo-1H-purin2-yl)acetamide; 2,9-Diacetylguanine; Acyclovir Diacetylguanine Impurity; Aciclovir Diacetylguanine Impurity; | 25MG,50MG | NA | 3056-33-5 | 235.2 | C9H9N5O3 | Aciclovir Impurity L; | Acyclovir – Impurity L |
ADI-IMPM-01-00255 | 2-[[2-(acetylamino)-6-oxo-1,6- dihydro-7H-purin-7- yl]methoxy]ethyl Acetate | Imp M | 2-[[2-(acetylamino)-6-oxo-1,6- dihydro-7H-purin-7- yl]methoxy]ethyl Acetate; |
25MG,50MG | NA | NA | 309.28 | C12H15N5O5 | Aciclovir Impurity M; | Acyclovir – Impurity M |
ADI-IMPM-01-00256 | 9-(2-Hydroxyethyl)guanine | Imp P | 2-Amino-1,9-dihydro-9-(2-hydroxyethyl)- 6H-purin-6-one; 9-(2′- Hydroxyethyl)guanine; NSC 40668; | 25MG,50MG | NA | 23169-33-7 | 195.18 | C7H9N5O2 | Aciclovir Impurity P; | Acyclovir – Impurity P |
ADI-IMPM-01-00257 | 2-Amino-9-((2- (hydroxymethoxy)ethoxy)methyl)- 1H-purin-6(9H)-one | Imp Q | 1H-Purin-6(9H)-one, 2-amino-9- ((2- (hydroxymethoxy)ethoxy)methyl)- | 25MG,50MG | Freezer | NA | 255.23 | C9H13N5O4 | Aciclovir Impurity Q; | Acyclovir – Impurity Q |
ADI-IMPM-01-00258 | 2,6-Dichloropurine | IH | 2,6-Dichloro-9H-purine; 2,6-Dichloro-1Hpurine; NSC 18395; | 25MG,50MG | NA | 5451-40-1 | 189 | C5H2Cl2N4 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00259 | Acyclovir L-Leucinate Hydrochloride | IH | L-Leucine 2-[(2-Amino-1,6-dihydro-6-oxo9H-purin-9-yl)methoxy]ethyl Ester Hydrochloride; Aciclovir L-Leucinate Hydrochloride; | 25MG,50MG | NA | 142963-69-7 | 374.82 | C14H23ClN6O4 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00260 | Acetyl 2-[(2-Formamide-1,6-dihydro-6- chloro-9H-purin-9yl)methoxy]ethyl Ester | IH | Acetyl 2-[(2-Formamide-1,6-dihydro-6- chloro-9H-purin-9yl)methoxy]ethyl Ester; | 25MG,50MG | Freezer | 1346598-89-7 | 316.7 | C14H23ClN6O4 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00261 | Acyclovir Monophosphate | IH | 2-Amino-1,9-dihydro-9-[[2- (phosphonooxy)ethoxy]methyl]-6H-purin6-one; Acycloguanosine Monophosphate; Aciclovir Monophosphate; | 25MG,50MG | Freezer | 66341-16-0 | 305.18 | C14H23ClN6O4 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00262 | 9-[[2-(α-LAlanyloxy)ethoxy]methyl]guanine Hydrochloride | IH | L-Alanine 2-[(2-Αmino-1,6-dihydro-6-oxo9H-purin-9-yl)methoxy]ethyl Ester, Monohydrochloride; 9-[[2-(a-LAlanyloxy)ethoxy]methyl]guanine Hydrochloride | 25MG,50MG | Refrigerator | r 84499-63-8 | 332.74 | C11H17ClN6O4 | 2’-O-α-L-Alanylacyclovir; Acyclovir L-Alaninate; | Acyclovir – In house impurity |
ADI-IMPM-01-00263 | 4-Azidobutanol 1-Acetate | IH | 4-Azidobutyl Acetate; 4-Azido-1-butanol 1-Acetate | 25MG,50MG | NA | 172468-38-1 | 157.17 | C6H11N3O2 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00264 | (S)-2-Azido Isovaleric Acid Cyclohexylammonium Salt | IH | (2S)-2-Azido-3-methylbutanoic Acid Cyclohexylammonium Salt; |
25MG,50MG | NA | 1217462-63-9 | 143.14 | C5H9N3O2 | (S)-2-Azido-3-methylbutyric Acid Cyclohexylammonium Salt; | Acyclovir – In house impurity |
ADI-IMPM-01-00265 | Bis [Acetyl 2-[(2-Formamide-1,6-dihydro-6- chloro-9H-purin-9yl)methoxy]ethyl Ester] | IH | (((2,2′- (Methylenebis(formylazanediyl))bis(6- chloro-9H-purine-9,2- diyl))bis(methylene))bis(oxy))bis(ethane2,1-diyl) Diacetate; | 25MG,50MG | NA | 1346600-44-9 | 639.4 | C23H24Cl2N10O8 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00266 | 0 Bis [2-[(2-Amino-1,6-dihydro-6-O-benzyl9H-purin-9yl)methoxy]ethanol] | IH | 2,2′-(((2,2′- (Methylenebis(azanediyl))bis(6- (benzyloxy)-9H-purine-9,2- diyl))bis(methylene))bis(oxy))diethanol; | 25MG,50MG | NA | 1346599-81-2 | 642.67 | C31H34N10O6 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00267 | Bis N-Benzyloxycarbonyl-6-O-benzylvalacyclovi | IH | Bis(N-benzyloxycarbonyl-L-valine-2-[(2- amino-1,6-dihydro-6-O-benzyl-9H-purin9yl)methoxy]ethyl Ester); | 25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphere | 1356350-92-9 | 1109.19 | C57H64N12O12 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00268 | Bis Valacyclovir | IH | (2S,2’S)-(((2,2′- (Methylenebis(azanediyl))bis(6-oxo-1Hpurine-9,2(6H)- diyl))bis(methylene))bis(oxy))bis(ethane2,1-diyl) bis(2-amino-3- methylbutanoate); | 25MG,50MG | NA | 1356019-51-6 | 660.68 | C27H40N12O8 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00269 | 6-Chloro Acyclovir Acetate | IH | 2-[(2-Amino-6-chloro-9H-purin-9- yl)methoxy]-ethanol 1-Acetate; 6-Chloro Aciclovir Acetate; | 25MG,50MG | Refrigerator | 81777-48-2 | 285.69 | C10H12ClN5O3 | 2-[(2-Amino-6-chloro-9H-purin-9- yl)methoxy]-ethanol Acetate (ester); Acetyl 2-[(2-Amine-1,6- dihydro-6-chloro-9H-purin9yl)methoxy]ethyl Ester | Acyclovir – In house impurity |
ADI-IMPM-01-00270 | Cidofovir Hydrate | IH | [[(1S)-2-(4-Amino-2-oxo-1(2H)- pyrimidinyl)-1- (hydroxymethyl)ethoxy]methyl]phosphoni c Acid Hydrate; 1-[(S)-3-Hydroxy-2- (phosphonomethoxy)propyl]cytosine Hydrate; | 25MG,50MG | Refrigerator | 113852-37-2 | 279.19 | C8H14N3O6P•xH2O | (S)-[[2-(4-Amino-2-oxo-1(2H)- pyrimidinyl)-1- (hydroxymethyl)ethoxy]methyl]pho sphonic Acid Hydrate; (S)-1-(3- hydroxy-2- phosphonomethoxypropyl)cytosine | Acyclovir – In house impurity |
ADI-IMPM-01-00271 | 1,3-Dioxolane | IH | Dioxolane; 1,3-Dioxacyclopentane; 1,3- Dioxolan; | 25MG,50MG | NA | 646-06-0 | 74.08 | C3H602 | Dihydro-1,3-dioxole,; 5-Crown-2; Ethylene Glycol Formal; Formal Glycol; Glycolformal; | Acyclovir – In house impurity |
ADI-IMPM-01-00272 | Guaninyl Valacyclovir | IH | N2-(Guanine-N2-yl)methyl]-9-[(2- hydroxyethoxy)methyl]guanine-Lvalinate; | 25MG,50MG | Refrigerator | NA | 487.47 | C19H25N11O5 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00273 | L-Valacyclovir Hydrochloride | IH | L-Valine 2-[(2-Amino-1,6-dihydro-6-oxo9H-purin-9yl)methoxy]ethyl Ester Hydrochlroride Salt; Valaciclovir Hydrochloride; | 25MG,50MG | NA | 124832-27-5 | 360.8 | C13H21ClN6O4 | 256U; 256U87 Hydrochloride; BW 256; BW 256U87; Valtrex; Zelitrex | Acyclovir – In house impurity |
ADI-IMPM-01-00274 | L-Valine 2-Hydroxyethyl Ester Tosylate | IH | para-Toluenesulfonate 2-Hydroxyethyl LValinate; L-Valine 2-Hydroxyethyl Ester 4- Methylbenzenesulfonate; | 25MG,50MG | NA | 86150-61-0 | 333.4 | C7H15NO3•C7H8O3S | Valacyclovir Related Compound F; A | Acyclovir – In house impurity |
ADI-IMPM-01-00275 | Acyclovir Alaninate | IH | 9-[(2- Hydroxyethoxy)methyl]guanine Lalaninate; (S)-2-((2-amino-6-oxo1H-purin-9(6H)-yl)methoxy)ethyl 2-aminopropanoate; Aciclovir Alaninate; | 25MG,50MG | NA | 84499-64-9 | 296.28 | C11H16N6O4 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00276 | Acyclovir L-Isoleucinate Hydrochloride | IH | L-Isoleucine 2-[(2-amino-1,6-dihydro-6- oxo-9H-purin-9-yl)methoxy]ethyl Ester Hydrochloride; Acyclovir Isoleucinate Hydrochloride; Aciclovir L-Isoleucinate Hydrochloride; | 25MG,50MG | NA | NA | 374.82 | C14H23ClN6O4 | (2S,3S)-2-((2-Amino-6-oxo-1Hpurin-9(6H)-yl)methoxy)ethyl 2- amino-3-methylpentanoate Hydrochloride; | Acyclovir – In house impurity |
ADI-IMPM-01-00277 | 6-Amino-9-((2- hydroxyethoxy)methyl)-1H-purin2(9H)-one | IH | 1H-Purin-2(9H)-one, 6-amino-9- ((2-hydroxyethoxy)methyl)-; | 25MG,50MG | NA | NA | 225.2 | C8H11N5O3 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00278 | 2-Amino-9-(((2- hydroxyethoxy)methoxy)methyl)- 1H-purin-6(9H)-one | IH | 1H-Purin-6(9H)-one, 2-amino-9- (((2- hydroxyethoxy)methoxy)methyl)-; | 25MG,50MG | NA | NA | 255.23 | C9H13N5O4 | NA | Acyclovir – In house impurity |
ADI-IMPM-01-00279 | Adamantamine | API | Tricyclo[3.3.1.1(3,7)]decan-1- amine; 1-Adamantanamine; Adamantamine; Adamantanamine; Adamantylamine; Amantadine; | 25MG,50MG | Refrigerator | 768-94-5 | 151.25 | C10H17N | 1-Aminoadamantane; Exp105-1; Pk-Merz;Symmetrel; 1-Aminoadamatane; 1- Aminotricyclo(3.3.1.13,7)dec ane; 1-Amantadine; | Adamantamine – API |
ADI-IMPM-01-00280 | N-Acetyl Adamantamine | IH | 1-Acetamidoadamantane; N-1-Acetyl-1- adamantanamine; 1- Acetamidotricyclo[3.3.1.1(3,7)]decane | 25MG,50MG | Freezer | 880-52-4 | 193.29 | C12H19NO | 1-Acetylaminoadamantane; N-(1- Adamanthyl)acetamide; | Adamantamine – In house impurity |
ADI-IMPM-01-00281 | Adapalene | API | 6-(4-Methoxy-3-tricyclo[3.3.1.13,7]dec-1- ylphenyl)-2-naphthalenecarboxylic Acid | 25MG,50MG | Room Temp | 106685-40-9 | 412.52 | C28H28O3 | 6-[3-(1-Adamantyl)-4- methoxyphenyl]-2-naphthoic Acid; CD-271; Differin | Adapalene – API |
ADI-IMPM-01-00282 | 2,2′-binaphthalene-6,6′-dicarboxylic acid | Imp A | 2,2′-Binaphthalene-6,6′-dicarboxylic Acid; [2,2′-Binaphthalene]-6,6′- dicarboxylic Acid; | 25MG,50MG | Refrigerator | 932033-58-4 | 342.34 | C22H14O4 | Adapalene Related Compound E | Adapalene – Impurity A |
ADI-IMPM-01-00283 | Hydroxy Adapalene | Imp B | 6-[3-(3-Hydroxytricyclo[3.3.1.13,7]dec-1- yl)-4-methoxyphenyl]-2- naphthalenecarboxylic Acid | 25MG,50MG | NA | 1346599-76-5 | 428.52 | C28H28O4 | NA | Adapalene – Impurity B |
ADI-IMPM-01-00284 | o-Adamantylanisole | IMP C | 1-(2- Methoxyphenyl)ticyclo[3.3.1.13,7]decane ; 1-(o-Methoxyphenyl)adamantane; | 25MG,50MG | Refrigerator | 43109-77-9 | 242.36 | C17H22O | Adapalene Related Compound C | Adapalene – Impurity C |
ADI-IMPM-01-00285 | 1,1′-[4,4′-bis(methoxy)biphenyl-3,3′- diyl]bis(tricyclo[3.3.1.13,7]decane) | Imp D | 2,2’-Bis-(1-adamantyl)-4,4’- dimethoxybiphenyl; 1,1′-(4,4′- Dimethoxy[1,1′-biphenyl]-3,3′- diyl)bistricyclo[3.3.1.13,7]decane | 25MG,50MG | NA | 932033-57-3 | 482.7 | C34H42O2 | Adapalene Related Compound D | Adapalene – Impurity D |
ADI-IMPM-01-00286 | Adefovir Phosphate Triethylamine | API | P’-[[2-(6-Amino-9H-purin-9- yl)ethoxy]methyl]isohypophosphoric Acid Triethylamine Salt; Adefovir Phosphate Triethylamine Salt; | 25MG,50MG | NA | 1346603-45-9 | 353.17 | 8H13N5O7P2• xC6H15 | [[2-(6-Amino-9H-purin-9- yl)ethoxy]methyl]isohypophosphori c Acid Triethylamine Salt; Adefovir Diphosphate Triethylamine Salt; ADV-DP; | Adefovir Phosphate Triethylamine Salt – API |
ADI-IMPM-01-00287 | Adefovir Monopivoxil | IH | Mono-POM Adefovir; Mono(pivaloyloxymethyl) Adefovir; | 25MG,50MG | Refrigerator | 142341-05-7 | 387.33 | C14H22N5O6P | 2,2-Dimethylpropanoic Acid [[[[2- (6-amino-9H-purin-9- yl)ethoxy]methyl]hydroxyphosphiny l]oxy]methyl Ester; | Adefovir Phosphate Triethylamine Salt – In house impurity |
ADI-IMPM-01-00288 | Adefovir Dipivoxil | IH | 2,2-Dimethyl-propanoic Acid 1,1′-[[[[2-(6- Amino-9H-purin-9- yl)ethoxy]methyl]phosphinylidene]bis(oxy methylene)] Ester; | 25MG,50MG | NA | 142340-99-6 | 501.47 | C20H32N5O8P | Hepsera; Preveon; bis(POM)- PMEA; | Adefovir Phosphate Triethylamine Salt – In house impurity |
ADI-IMPM-01-00289 | 6-Amino-9H-purine-9-acetic Acid | IH | 9-Carboxymethyladenine; Adenin-9- ylacetic Acid; | 25MG,50MG | NA | 20128-29-4 | 193.16 | C7H7N5O2 | NA | Adefovir Phosphate Triethylamine Salt – In house impurity |
ADI-IMPM-01-00290 | Mono-POM Ethyl Adefovir | IH | Mono(pivaloyloxymethyl) Ethyl Adefovir; 2,2-Dimethylpropanoic Acid [[[[2-(6- amino-9H-purin-9- yl)ethoxy]methyl]ethoxyphosphinyl]oxy]m ethyl ester; | 25MG,50MG | Refrigerator | 142341-04-6 | 415.38 | C16H26N5O6P | NA | Adefovir Phosphate Triethylamine Salt – In house impurity |
ADI-IMPM-01-00291 | Adenosine | API | 9-β-D-Ribofuranosyl-9H-purin-6-amine; 9-β-D-Ribofuranosyladenine; Adenine Riboside; Adenocard; Adenocor; Adenogesic; | 25MG,50MG | Refrigerator | 58-61-7 | 267.24 | C10H13N5O4 | Adenoscan; Adrekar; Boniton; DAdenosine; 1-(6-Amino-9H-purin-9- yl)-1-deoxy-β-D-ribofuranose; Myocol; NSC 7652 | Adenosine – API |
ADI-IMPM-01-00292 | Adenine | Imp A | 9H-Purin-6-amine; 1H-Purin-6-amine; Adenine; 1,6-Dihydro-6-iminopurine; 3,6- Dihydro-6-iminopurine; 3H-Purin-6- amine; 6-Amino-1H-purine; | 25MG,50MG | Refrigerator | 73-24-5 | 135.13 | C5H5N5 | 6-Amino-3H-purine; 6-Amino-9Hpurine; 6-Aminopurine; 7H-Purin-6- amine; 9H-Adenine; Adeninimine; Leuco-4; NSC 14666; Pedatisectine B; Vitamin B4; | Adenosine – Impurity A |
ADI-IMPM-01-00293 | Uridine | Imp F | 1-β-D-Ribofuranosyluracil; β-Uridine; 1-βD-Ribofuranosyluracil; β-Uridine; 1-β-DRibofuranosyl-2,4(1H,3H)- pyrimidinedione; | 25MG,50MG | Freezer | 58-96-8 | 244.2 | C9H12N2O6 | NSC 20256; | Adenosine – Impurity F |
ADI-IMPM-01-00294 | Inosine | Imp G | (-)-Inosine; 1,9-Dihydro-9-β-Dribofuranosyl-6H-purin-6-one; 9-β-DRibofuranosylhypoxanthine; | 25MG,50MG | Freezer | 58-63-9 | 268.23 | C10H12N4O5 | Hypoxanthine 9-β-Dribofuranoside; Hypoxanthine Ribonucleoside; Hypoxanthine Riboside; |
Adenosine – Impurity G |
ADI-IMPM-01-00295 | Guanosine | Imp H | 2-Amino-9-β-D-ribofuranosyl-1,9-dihydro6H-purin-6-one; 2-Amino-9-beta-Dribofuranosyl-1,9-dihydro-6H-purin-6- one; | 25MG,50MG | NA | 118-00-3 | 283.24 | C10H13N5O5 | DL-Guanosine; Guanine Ribonucleoside; 9-β-DRibofuranosylguanine; 2- Aminoinosine; NSC 19994; Vernine | Adenosine – Impurity H |
ADI-IMPM-01-00296 | Adenosine 5’-Monophosphoramidate Sodium Salt | IH | Adenosine 5′-(Hydrogen Phosphoramidate) Monosodium Salt; | 25MG,50MG | NA | 102029-68-5 | 368.22 | C10H14N6NaO6P | NA | Adenosine – In house impurity |
ADI-IMPM-01-00297 | 6-Amino-9-methylpurine (9-Methyl Adenine) | IH | 9-Methyl-9H-purin-6-amine; | 25MG,50MG | Freezer | 700-00-5 | 149.15 | C6H7N5 | 6-Amino-9-methylpurine; 9-Methyl9H-adenine; 9-Methyladenine; N 838; N9-Methyladenine; NSC 7843; | Adenosine – In house impurity |
ADI-IMPM-01-00298 | 2-Aminopurine Dihydrochloride | IH | 9H-Purin-2-amine Dihydrochloride; Isoadenine Dihydrochloride; | 25MG,50MG | NA | 76124-64-6 | 208.05 | C5H7Cl2N5 | NA | Adenosine – In house impurity |
ADI-IMPM-01-00299 | 6-Amino-9H-purine-9-propanoic Acid | IH | 3-(6-Amino-9H-purin-9-yl)propionic Acid; | 25MG,50MG | Refrigerator | 4244-47-7 | 207.19 | C8H9N5O2 | 3-(6-Aminopurin-9-yl)propionic Acid; 9-(2-Carboxyethyl)adenine; NSC 159708; NSC 81016; | Adenosine – In house impurity |
ADI-IMPM-01-00300 | 6-Benzylaminopurine 9-(α-D-glucoside) | IH | N6-Benzyladenine 9-Glucoside; | 25MG,50MG | NA | 4294-17-1 | 387.39 | C18H21N5O5 | NA | Adenosine – In house impurity |
ADI-IMPM-01-00301 | N-Biotinyl Dopamine | IH | (3aS,4S,6aR)-N-[2-(3,4- dihydroxyphenyl)ethyl]hexahydro-2-oxo1H- thieno[3,4-d]imidazole-4- pentanamide; | 25MG,50MG | NA | 241142-94-9 | 379.47 | C18H25N3O4S | NA | Adenosine – In house impurity |
ADI-IMPM-01-00302 | 5′-O-[Bis(4-methoxyphenyl)phenylmethyl]- 2′-deoxy-N-methyladenosine | IH | 5’-O-(4,4′-Dimethoxytriphenylmethyl)-N6- methyl-2′-deoxyadenosine; |
25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 98056-69-0 | 567.63 | C18H25N3O4S | 5′-O-DMT-2′-deoxy-N-methyladenosine; 5′-O-DMT-N6-methyl2′-deoxyadenosine; | Adenosine – In house impurity |
ADI-IMPM-01-00303 | 2-Chloroadenosine 5’-Monophosphate Ditriethylamine Salt | IH | 2-Chloro-5′-adenylic Acid; 2-Chloroadenosine 5′-(Dihydrogen Phosphate) Ditriethylamine; 2-Chloro-AMP Ditriethylamine; | 25MG,50MG | NA | NA | 584.05 | C22H43ClN7O7P | NA | Adenosine – In house impurity |
ADI-IMPM-01-00304 | 2’-Deoxy-β-D-adenosine Monohydrate | IH | 2-Deoxyadenine-9-β-D-erythro-pentofuranoside Hydrate; NSC 141848; NSC 143510; NSC 83258; dA; 1-(6-Amino-9Hpurin-9-yl)-1,2-dideoxy-β-D-ribofuranose Hydrate; | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 16373-93-6 | 269.26 | C10H15N5O4 | 2’-Deoxy-β-D-adenosine Monohydrate; 9-(2-Deoxy-β-Derythro-pentofuranosyl)adenine; 9- (2-Deoxy-β-D-erythropentofuranosyl)-9H-purin-6-amine Hydrate; Adenine Deoxyribonucleoside Hydrate; Adenine Deoxyribose Hydrate; Adenyldeoxyriboside Hydrate; Deoxyadenosine Hydrate; |
Adenosine – In house impurity |
ADI-IMPM-01-00305 | 4′,6-Diamidino-2-phenylindole Dihydrochloride | IH | 4′,6-Diamidino-2-phenylindole Dihydrochloride; 2-[4- (Aminoiminomethyl)phenyl]-1H-indole-6- carboximidamide Hydrochloride; | 25MG,50MG | NA | 28718-90-3 | 350.25 | C16H17Cl2N5 | DAPI; 2-(4-Amidinophenyl)-6- indolecarbamidine, Dihydrochloride | Adenosine – In house impurity |
ADI-IMPM-01-00306 | 2,6-Diaminopurine Hemisulfate Hemihydrate | IH | 9H-Purine-2,6-diamine Sulfate Hydrate; 2-Aminoadenine Sulfate Hydrate; | 25MG,50MG | Refrigerator | 69369-16-0 | 199.2 | C5H6N6•1/2H2SO4•1/2H | NSC 743 Sulfate Hydrate; SQ 21065 Sulfate Hydrate; | Adenosine – In house impurity |
ADI-IMPM-01-00307 | Eritadenine | IH | (αR,βR)-6-Amino-α,β-dihydroxy-9Hpurine-9-butanoic Acid; 4-(6-Amino-9Hpurin-9-yl)-4-deoxy-D-erythronic Acid | 25MG,50MG | NA | 23918-98-1 | 253.21 | C9H11N5O4 | 4-(6-Aminopurin-9-yl)-4-deoxy-Derythronic Acid; Lentinacin; Lentysine; 4-(9-Adenyl)-D-erythro2,3-dihydroxybutyric Acid; DEritadenine; | Adenosine – In house impurity |
ADI-IMPM-01-00308 | Flavine Adenine Dinucleotide Disodium Salt | IH | Riboflavin 5′-(Trihydrogen Diphosphate) P’5′-Ester with Adenosine Disodium; Adenine-flavine Dinucleotide Disodium; Adenine-riboflavin Dinucleotide Disodium; | 25MG,50MG | Freezer | 146-14-5 | 829.51 | C27H31N9Na2O15P2 | Adenine-riboflavine Dinucleotide Disodium; FAD Disodium; Fademin Disodium; Flavinat Disodium; Flavine Adenosine Diphosphate Disodium; Flavitan Disodium; NSC 112207; Riboflavinadenine Dinucleotide Dinucleotide Disodium; | Adenosine – In house impurity |
ADI-IMPM-01-00309 | Fludarabine | IH | 9-β-D-Arabinofuranosyl-2-fluoro-9Hpurin-6-amine; 2-Fluoro-9-β-Darabinofuranosyladenine; | 25MG,50MG | NA | 21679-14-1 | 285.23 | C10H12FN5O4 2 | 2-Fluoroadenine Arabinoside; NSC 118218; NSC 118218H; | Adenosine – In house impurity |
ADI-IMPM-01-00310 | 4,5,6-Triaminopyrimidine Sulfate Hydrate | IH | 4,5,6-Pyrimidinetriamine Sulfate Monohydrate; Pyrimidine-4,5,6- triamine Sulfate Hydrate; NSC 49184; | 25MG,50MG | NA | 6640-23-9 | 241.23 | C4H11N5O5S | NA | Adenosine – In house impurity |
ADI-IMPM-01-00311 | Nicotinic Acid Riboside Methyl Ester Triflate | IH | 3-(Methoxycarbonyl)-1-β-Dribofuranosyl-pyridinium; | 25MG,50MG | NA | NA | 419.33 | C13H16F3NO9S | NA | Adenosine – In house impurity |
ADI-IMPM-01-00312 | 8-Hydroxy Adenine | IH | 6-Amino-7,9-dihydro-8H-purin-8-one; 6- Amino-1,7-dihydro-8H-purin-8-one; 6- Amino-purin-8-ol; 6-Amino-8- hydroxypurine; | 25MG,50MG | NA | 21149-26-8 | 151.13 | C5H5N5O | 7,8-Dihydro-8-oxoadenine; 8-Oxo7,8-dihydroadenine; 8- Oxoadenine; NSC 24123; Oksaden; Oxaden; Oxyadenine | Adenosine – In house impurity |
ADI-IMPM-01-00313 | 4-Hydroxy Estradiol 1-N3-Adenine | IH | (17β)-1-(6-Amino-3H-purin-3-yl)estra1,3,5(10)-triene-3,4,17-triol; 4-OH-E2-1- N3Ade; | 25MG,50MG | NA | 428506-88-1 | 421.49 | C23H27N5O3 | NA | Adenosine – In house impurity |
ADI-IMPM-01-00314 | 4-Hydroxy Estrone 1-N3-Adenine | IH | 1-(6-Amino-3H-purin-3-yl)-3,4- dihydroxyestra-1,3,5(10)-trien-17-one; 4- OH-E1-1-N3Ade; | 25MG,50MG | Refrigerato | 488841-24-3 | 419.48 | C23H25N5O3 | NA | Adenosine – In house impurity |
ADI-IMPM-01-00315 | N6-Isopentenyladenosine | IH | N-(3-Methyl-2-butenyl)-adenosine; 6-(3- Methyl-2-butenylamino)-9-β-Dribofuranosylpurine; NIsopentenyladenosine; N6-(2- Isopentenyl)adenosine; N6-(3-Methyl-2- butenyl)adenosine; N6-(Δ2- Isopentenyl)adenine riboside; N6-(Δ2- Isopentenyl)adenosine; | 25MG,50MG | Refrigerato | 7724-76-7 | 335.36 | C15H21N5O4 | 6-(3-Methyl-2-butenylamino)-9-βribofuranosylpurine; 6-(3-Methyl-2- butenylamino)-β,Dribofuranosylpurine; 6-(3-Methyl-2- butenylamino)purine riboside; 6- (γ,γ-Dimethylallylamino)purine riboside; IPA; Isopentenyladenine riboside; Isopentenyladenosine; Isopentenyladenosine riboside; N- (3-Methyl-2-butenyl)adenosine; |
Adenosine – In house impurity |
ADI-IMPM-01-00316 | Trans-Ned-19 | IH | (1R,3S)-1-[3-[[4-(2-Fluorophenyl)-1- piperazinyl]methyl]-4-methoxyphenyl]- 2,3,4,9-tetrahydro-1H-Pyrido[3,4-b]indole3-carboxylic Acid; | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere |
1354235-96-3 | 514.59 | C30H31FN4O3 | NA | Adenosine – In house impurity |
ADI-IMPM-01-00317 | Nicotinamide Riboside Triflate, α/β mixture | IH | 3-(Aminocarbonyl)-1-Dribofuranosylpyridinium Trifluoromethanesulfonic Acid Salt; | 25MG,50MG | NA | 445489-49-6 | 404.32 | C12H15F3N2O8S | NAR; Ribosylnicotinamide Triflate | Adenosine – In house impurity |
ADI-IMPM-01-00318 | β-Nicotinic Acid Mononucleotide | IH | 3-Carboxy-1-(5-O-phosphono-β-Dribofuranosyl)pyridinium Inner Salt; | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 321-02-8 | 335.2 | C11H14NO9P | 3-Carboxy-1-β-Dribofuranosylpyridinium Hydroxide 5′-Phosphate Inner Salt; Nicotinate Mononucleotide; Nicotinate Ribonucleotide; Nicotinic Acid Ribonucleotide; Nicotinic Acid Ribotide; Nicotinic Mononucleotide; β-NaMN; | Adenosine – In house impurity |
ADI-IMPM-01-00319 | Nicotinic Acid Riboside | IH | 3-Carboxy-1-β-D-ribofuranosylpyridinium Inner Salt; | 25MG,50MG | Refrigerat or | 17720-18-2 | 255.22 | C11H13NO6 | 3-Carboxy-1-β-D-ribofuranosyl- pyridinium Hydroxide Inner Salt; Nicotinic Acid Ribonucleoside; Nicotinic Riboside; | Adenosine – In house impurity |
ADI-IMPM-01-00320 | 2,6-Dichloropurine-9-β-D-riboside | IH | 2,6-Dichloro-9-β-D-ribofuranosyl9H-purine; (2R,3R,4S,5R)-2-(2,6- Dichloro-9H-purin-9-yl)-5- (hydroxymethyl)tetrahydrofuran3,4-diol; | 25MG,50MG | Refrigerat or | 13276-52-3 | 321.12 | C10H10Cl2N4O4 | (2S,3R,4S,5R)-2-(5,7- Dichloro-3H-pyrazolo[4,3- d]pyrimidin-3-yl)-5- (hydroxymethyl)tetrahydrofur an-3,4-diol; | Adenosine – In house impurity |
ADI-IMPM-01-00321 | Tetrahydrouridine | IH | Tetrahydro-4-hydroxy-1-β-Dribofuranosyl-2(1H)-pyrimidinone; 1-(β-D-Ribofuranosyl)-4- hydroxytetrahydro-1(1H)- pyrimidinone; 3,4,5,6- Tetrahydrouridine; | 25MG,50MG | Amber Vial, Freezer, Under inert atmospher e | 18771-50-1 | 248.23 | C9H16N2O6 | NA | Adenosine – In house impurity |
ADI-IMPM-01-00322 | 5′-Deoxy-5′-(methylthio)adenosine | IH | Methyl Thioadenosine; 5′-SMethyl-5′-thioadenosine; 5′- (Methylthio)-5′-deoxyadenosine; 5′-Deoxy(methylthio)adenosine | 25MG,50MG | Refrigerator | 2457-80-9 | 297.33 | C11H15N5O3S | 5’-S-Methylthioadenosine; 1- (6-Amino-9H-purin-9-yl)-1- deoxy-5-S-methyl-5-thio-β-Dribofuranose; Vitamin L2; | Adenosine – In house impurity |
ADI-IMPM-01-00323 | S-Adenosyl-L-homocysteine | IH | S-(5’-Adenosyl)-L-homocysteine; S-(5’-Deoxyadenosin-5’-yl)-Lhomocysteine; L-5’-S-(3-Amino-3- carboxypropyl)- 5’-thioadenosine; Adenosyl-L-homocysteine; | 25MG,50MG | Refrigerator | 979-92-0 | 384.41 | C14H20N6O5S | Adenosylhomocysteine; L-SAdenosylhomocysteine; SAdenosylhomocysteine; | Adenosine – In house impurity |
ADI-IMPM-01-00324 | Ademethionine | IH | (2S)-2-Amino-4-((((2S,3S,4R,5R)- 5-(6-amino-9H-purin-9-yl)-3,4- dihydroxytetrahydrofuran-2- yl)methyl)(methyl)sulfonio)butano ate; S-adenosylmethionine | 25MG,50MG | NA | 29908-03-0 | 398.44 | C15H22N6O5S | L-Methionine; 2-S-AdenosylL-methionine; | Adenosine – In house impurity |
ADI-IMPM-01-00325 | S-Adenosylmethioninamine | IH | S-Adenosyl-3- methylthiopropylamine; 3- Aminopropyl-[[(2S,3S,4R,5R)-5- (6-aminopurin-9-yl)-3,4- dihydroxyoxolan-2-yl]methyl]- methylsulfanium; (5-Deoxy-5- | 25MG,50MG | NA | 22365-13-5 | 355.44 | C14H23N6O3S+ | (((2S,3S,4R,5R)-5-(6-Amino9H-purin-9-yl)-3,4- dihydroxytetrahydrofuran-2- yl)methyl)(3- aminopropyl)(methyl)sulfoni um; | Adenosine – In house impurity |
ADI-IMPM-01-00326 | Aderbasib | API | (6S,7S)-7-[(Hydroxyamino)carbonyl]-6- [(4-phenyl-1-piperazinyl)carbonyl]-5- azaspiro[2.5]octane-5-carboxylic Acid Methyl Ester; INCB 007839; | 25MG,50MG | NA | 791828-58-5 | 416.47 | C21H28N4O5 | NA | Aderbasib – API |
ADI-IMPM-01-00327 | Adiphenine Hydrochloride | API | α-Phenylbenzeneacetic Acid 2- (Diethylamino)ethyl Ester Hydrochloride; Diphenylacetic Acid 2- (Diethylamino)ethyl Ester Hydrochloride; 2-Diethylaminoethyl Diphenylacetate Hydrochloride; Adifenin Hydrochloride; Adiphen Hydrochloride; | 25MG,50MG | Refrigerator | 50-42-0 | 347.88 | C20H26ClNO2 | Difacil Hydrochloride; Diphacil Hydrochloride; NSC 129224; Patrovina; Paxil; Sentiv; Spasmolytin; Spasmolytin Hydrochloride; Spasnil; Trasentin Hydrochloride; Trasentine Hydrochloride; Vegantin; βDiethylaminoethyl Diphenylacetate | Adiphenine Hydrochloride – API |
ADI-IMPM-01-00328 | Adipic Acid | API | Adipic Acid; 1,4-Butanedicarboxylic Acid; 1,6-Hexanedioic Acid; Acifloctin; Acinetten; Adilactetten | 25MG,50MG | NA | 124-04-9 | 146.14 | C6H10O4 | Adipinic Acid; Asapic; E 355; Inipol DS; NSC 7622; NSC 87836; | Adipic Acid – API |
ADI-IMPM-01-00329 | Glutaric Acid | Imp A | Pentanedioic Acid; 1,3- Propanedicarboxylic Acid; | 25MG,50MG | Refrigerator | 110-94-1 | 132.11 | C5H8O4 | 1,5-Pentanedioic Acid; NSC 9238 | Adipic Acid – Impurity A |
ADI-IMPM-01-00330 | Succinic Acid | Imp B | Butanedioic Acid; 1,2-Ethanedicarboxylic Acid; 1,4-Butanedioic Acid; A 12084; Amber Acid; Asuccin; | 25MG,50MG | NA | 110-15-6 | 118.09 | C4H6O4 | Dihydrofumaric Acid; Katasuccin; NSC 106449; NSC 25949; Wormwood Acid; Yantar-antitox; | Adipic Acid – Impurity B |
ADI-IMPM-01-00331 | Pimelic Acid | Imp C | 1,5-Pentanedicarboxylic Acid; 1,7- Heptanedioic Acid; | 25MG,50MG | Freezer | 111-16-0 | 160.17 | C7H12O4 | Pileric Acid; Heptanedioic Acid; | Adipic Acid – Impurity C |
ADI-IMPM-01-00332 | Adrenaline | API | Epinephrine; 4-[(1R)-1-Hydroxy-2- (methylamino)ethyl]benzene-1,2- diol; (R)-4-(1-Hydroxy-2- (methylamino)ethyl)benzene-1,2- diol; L-(-)-Epinephrine; 4-[(1R)-1- | 25MG,50MG | Freezer | 51-43-4 | 183.2 | C9H13NO3 | Renoform; Renostypticin; Adnephrine; Adrenal; Adrenalin; L-Epinephrine; Levoepinephrine; (−)- Adrenalin; (−)-Epinephrine; | Adrenaline – API |
ADI-IMPM-01-00333 | Noradrenaline | Imp B | (−)-Norepinephrine; (R)-4-(2- Amino-1-hydroxyethyl)-1,2- benzenediol; L-Arterenol; LNoradrenaline; Levarterenol; | 25MG,50MG | NA | 51-41-2 | 169.18 | C8H11NO3 | (R)-4-(2-Amino-1- hydroxyethyl)benzene-1,2- diol; (1R)-2-Amino-1-(3,4- dihydroxyphenyl)ethanol; Epinephrine Impurity B | Adrenaline – Impurity B |
ADI-IMPM-01-00334 | Adrenalone | Imp C | 1-(3,4-Dihydroxyphenyl)-2- (methylamino)ethanone; 3,4- Dihydroxy-αmethylaminoacetophenone; 3’,4’- Dihydroxy-2- | 25MG,50MG | Refrigerat or | 99-45-6 | 181.19 | C9H11NO3 | Adrenolone; Adrenon; Adrenone; Chemosan; Haemodan; Kephrine; Ketogaze; Methaminoacetocatechol; | Adrenaline – Impurity C |
ADI-IMPM-01-00335 | 4-[(1R)-2-(benzylmethylamino)-1- hydroxyethyl]benzene-1,2-diol | Imp D | (R)-4-(2-(Benzyl(methyl)amino)-1- hydroxyethyl)benzene-1,2-diol; | 25MG,50MG | NA | NA | 273.33 | C16H19NO3 | Epinephrine Impurity D; | Adrenaline – Impurity D |
ADI-IMPM-01-00336 | 2-(Benzylmethylamino)-1-(3,4- dihydroxyphenyl)ethanone | Imp E | 2-(Benzylmethylamino)-3′,4′- dihydroxyacetophenone; 1-(3,4- Dihydroxyphenyl)-2- [methyl(phenylmethyl)amino]etha none; | 25MG,50MG | Freezer | 36467-25-1 | 271.31 | C16H17NO3 | α-Benzylmethylamino-3,4- dihydroxyacetophenone; Epinephrine Impurity E; | Adrenaline – Impurity E |
ADI-IMPM-01-00337 | (1R)-1-(3,4-Dihydroxyphenyl)-2- (methylamino)ethanesulfonic Acid | Imp F | (R)-1-(3,4-Dihydroxyphenyl)-2- (methylamino)ethanesulfonic Acid; Adrenaline betaSulphonate; Adrenaline βSulphonate; | 25MG,50MG | NA | 78995-75-2 | 247.27 | C9H13NO5S | Epinephrine Impurity F | Adrenaline – Impurity F |
ADI-IMPM-01-00338 | D-(+)-Epinephrine | IH | (S)-4-(1-Hydroxy-2- (methylamino)ethyl)benzene-1,2- diol; 4-[(1S)-1-Hydroxy-2- (methylamino)ethyl]-1,2- benzenediol; (+)-3,4-Dihydroxy-α- | 25MG,50MG | Freezer | 150-05-0 | 183.2 | C9H13NO3 | (+)-1-(3,4-Dihydroxyphenyl)- 2-methylaminoethanol; (+)- Adrenaline; (+)-Epinephrine; (S)-Adrenaline; (S)- Epinephrine; D(+)- Adrenaline; D-Adrenaline; | Adrenaline – In house impurity |
ADI-IMPM-01-00339 | Adrenaline Tartrate | API | (−)-Epinephrine (+)-bitartrate Salt; L-3,4- Dihydroxy-α-(methylaminomethyl)benzyl alcohol D-hydrogen Bitartrate Salt; | 25MG,50MG | NA | 51-42-3 | 333.29 | C9H13NO3.C4H6O6 | L-Adrenaline (+)-bitartrate salt; LAdrenaline D-hydrogentartrate; LEpinephrine D-hydrogentartrate; Adrenaline Acid Tartrate; Epinephrine Acid Tartrate | Adrenaline Tartrate – API |
ADI-IMPM-01-00340 | Noradrenaline | Imp B | (−)-Norepinephrine; (R)-4-(2-Amino-1- hydroxyethyl)-1,2-benzenediol; LArterenol; L-Noradrenaline; Levarterenol; | 25MG,50MG | Freezer | 51-41-2 | 169.18 | C8H11NO3 | R)-4-(2-Amino-1- hydroxyethyl)benzene-1,2-diol; (1R)-2-Amino-1-(3,4- dihydroxyphenyl)ethanol; | Adrenaline Tartrate – Impurity B |
ADI-IMPM-01-00341 | Adrenalone Hydrochloride Monohydrate | IMP C | 3′,4′-Dihydroxy-2- (methylamino)acetophenone Hydrochloride Hydrate; 1-(3,4- Dihydroxyphenyl)-2- (methylamino)ethanone Hydrochloride Hydrate; | 25MG,50MG | NA | NA | 217.65 | C9H12ClNO3•H2O | Adrenone Hydrochloride Hydrate; Kephrine Hydrochloride Hydrate; Styphnonasal Hydrate; αMethylamino-3,4- dihydroxyacetophenone Hydrochloride Hydrate; αMethylamino-3’,4’- |
Adrenaline Tartrate – Impurity C |
ADI-IMPM-01-00342 | 4-[(1R)-2-(benzylmethylamino)-1- hydroxyethyl]benzene-1,2-diol | Imp D | (R)-4-(2-(Benzyl(methyl)amino)-1- hydroxyethyl)benzene-1,2-diol; | 25MG,50MG | NA | NA | 273.33 | C16H19NO3 | NA | Adrenaline Tartrate – Impurity D |
ADI-IMPM-01-00343 | 2-(Benzylmethylamino)-1-(3,4- dihydroxyphenyl)ethanone | Imp E | 2-(Benzylmethylamino)-3′,4′- dihydroxyacetophenone; 1-(3,4- Dihydroxyphenyl)-2- [methyl(phenylmethyl)amino]ethanone | 25MG,50MG | Refrigerator | 36467-25-1 | 271.31 | C16H19NO3 | α-Benzylmethylamino-3,4- dihydroxyacetophenone; | Adrenaline Tartrate – Impurity E |
ADI-IMPM-01-00344 | Aescin | API | Escin; 3-(4-O-β-D-glucopyranosyl-2-O-βD-xylopyranosyl-β-Dglucopyranuronoside)escigenin 3- Hydroxy-2-methylbutyrate Acetate; 3,5- Epoxypicene, escin deriv.; Oleanane Escin deriv.; Aescine; Aescusan; Ba 2672; Escusan; Eskuzan; Flebostasin Retard Venocin; β-Escinic Acid | 25MG,50MG | NA | 6805-41-0 | 1131.26 | C55H86O24 | (2S,3S,4S,5R,6R)-6- [[(4S,6aR,6bS,8R,8aR,9R,10R,14 bR)-9-acetoxy-8-hydroxy-4,8abis(hydroxymethyl)- 4,6a,6b,11,11,14b-hexamethyl-10- [(Z)-2-methylbut-2-enoyl]oxy1,2,3,4a,5,6,7,8,9,10,12,12a,14,14 a-tetradecahydropicen-3-yl]oxy]-4- hydroxy-3,5-bis[[(2S,3R,4S,5S,6R)- 3,4,5-trihydroxy-6- (hydroxymethyl)tetrahydropyran-2- yl]oxy]tetrahydropyran-2-carboxylic acid; |
Aescin – API |
ADI-IMPM-01-00345 | Afatinib | API | (2E)-N-[4-[(3-Chloro-4- fluorophenyl)amino]-7-[[(3S)-tetrahydro-3- furanyl]oxy]-6-quinazolinyl]-4- (dimethylamino)-2-butenamide; BIBW 2992; | 25MG,50MG | NA | 850140-72-6 | 485.94 | C24H25ClFN5O3 | NA | Afatinib – API |
ADI-IMPM-01-00346 | N-(3,4-dichlorophenyl)-7-fluoro-6- nitroquinazolin-4-amine | IH | Afatinib Impurity 4; | 25MG,50MG | NA | NA | 353.14 | C14H7Cl2FN4O2 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00347 | (S)-N4-(4-Fluorophenyl)-7- ((tetrahydrofuran-3-yl)oxy)quinazoline-4,6- diamine | IH | (S)-N4-(4-Fluorophenyl)-7- ((tetrahydrofuran-3-yl)oxy)quinazoline4,6-diamine; | 25MG,50MG | NA | NA | 340.35 | C18H17FN4O2 | Afatinib Impurity 6; | Afatinib – In house impurity |
ADI-IMPM-01-00348 | (S)-N4-phenyl-7-((tetrahydrofuran-3- yl)oxy)quinazoline-4,6-diamine | IH | (S)-N4-phenyl-7-((tetrahydrofuran-3- yl)oxy)quinazoline-4,6-diamine | 25MG,50MG | NA | NA | 322.36 | C18H18N4O2 | Afatinib Impurity 7; | Afatinib – In house impurity |
ADI-IMPM-01-00349 | (S)-N4-(3-chlorophenyl)-7- ((tetrahydrofuran-3-yl)oxy)quinazoline-4,6- diamine | IH | (S)-N4-(3-chlorophenyl)-7- ((tetrahydrofuran-3-yl)oxy)quinazoline4,6-diamine; | 25MG,50MG | NA | NA | 356.81 | C18H17ClN4O2 | Afatinib Impurity 8 | Afatinib – In house impurity |
ADI-IMPM-01-00350 | (S)-N4-(3-Chloro-4-fluorophenyl)-7- ((tetrahydrofuran-3- yl)oxy)quinazoline-4,6-diamine | IH | Afatinib-des(4-dimethylamino-2- en-1-oxo)butyl (Contained ~8.5% Ethanol); N4-(3-Chloro-4- fluorophenyl)-7-[[(3S)-tetrahydro3-furanyl]oxy]-4,6- quinazolinediamine; Des(4- dimethylamino-2-en-1-oxo)butyl | 25MG,50MG | Refrigerat or | 314771-76-1 | 374.8 | C18H16ClFN4O2 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00351 | (S)-N-(4-((3-Chloro-4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)formamide | IH | Des(N,N-Dimethylprop-2-enyl-1- Amine) Afatinib; Des(4- dimethylamino-2-en-1-oxo)butyl Afatinib N6 Formyl; | 25MG,50MG | NA | NA | 402.81 | C19H16ClFN4O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00352 | (S)-N-(((4-((3-Chloro-4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6- yl)amino)methylene)-Nmethylmethanaminium | IH | N-Methylmethanaminium, (S)-N- (((4-((3-chloro-4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6- yl)amino)methylene)-; | 25MG,50MG | NA | NA | 430.88 | C21H22ClFN5O2 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00353 | 1-(4-((3-Chloro-4- fluorophenyl)amino)-7-(((S)- tetrahydrofuran-3-yl)oxy)quinazolin6-yl)-5-hydroxypyrrolidin-2-one | IH | Des-(4-dimethylamino-2-en-1- oxo)butylamino 6-(5-Hydroxypyrrolidin-2-on-1-yl) Afatinib | 25MG,50MG | NA | NA | 458.87 | C22H20ClFN4O4 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00354 | (S)-N-(4-((3-Chloro-4- fluorophenyl)amino)-7-(((S)- tetrahydrofuran-3-yl)oxy)quinazolin6-yl)-4-(dimethylamino)-3- hydroxybutanamide | IH | 3-Hydroxybutanamide, (S)-N-(4- ((3-chloro-4-fluorophenyl)amino)- 7-(((S)-tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-4- (dimethylamino)-; Afatinib SHydroxy Analog | 25MG,50MG | NA | NA | 503.95 | C24H27ClFN5O4 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00355 | (R)-N-(4-((3-Chloro-4- fluorophenyl)amino)-7-(((S)- tetrahydrofuran-3-yl)oxy)quinazolin6-yl)-4-(dimethylamino)-3- hydroxybutanamide | IH | 3-Hydroxybutanamide, (R)-N-(4- ((3-chloro-4-fluorophenyl)amino)- 7-(((S)-tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-4- (dimethylamino)-; Afatinib RHydroxy Analog |
25MG,50MG | NA | NA | 503.95 | C24H27ClFN5O4 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00356 | (S,E)-N-(4-((4-Chloro-3- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-4- (dimethylamino)but-2-enamide | IH | 2-Enamide, (S,E)-N-(4-((4-chloro3-fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-4- (dimethylamino)but-; Afatinib 4- Chloro Analog; | 25MG,50MG | NA | NA | 485.94 | C24H25ClFN5O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00357 | (S,E)-4-(Dimethylamino)-N-(4-((4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)but-2- enamide | IH | 3-Dechloro Afatinib; | 25MG,50MG | NA | NA | 451.49 | C24H26FN5O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00358 | (S,Z)-N-(4-((3-Chloro-4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-4- (dimethylamino)but-2-enamide | IH | Z-Afatinib; (2Z)-Afatinib; | 25MG,50MG | Amber Vial, Freezer, Under inert atmospher e | 1680184-59-1 | 485.94 | C24H25ClFN5O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00359 | (R,E)-N-(4-((3-chloro-4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-4- (dimethylamino)but-2-enamide | IH | 2-Enamide, (R,E)-N-(4-((3-chloro4-fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-4- (dimethylamino)but-; | 25MG,50MG | NA | NA | 485.94 | C24H25ClFN5O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00360 | (S)-N-(3-Chloro-4-fluorophenyl)-6- nitro-7-(tetrahydrofuran-3- yloxy)quinazolin-4-amine | IH | ((Tetrahydrofuran-3- yl)oxy)quinazolin-4-amine, (S)-N- (3-chloro-4-fluorophenyl)-6-nitro-7 | 25MG,50MG | NA | 314771-88-5 | 404.78 | C18H14ClFN4O4 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00361 | (S,E)-N-(4-((3,4- Difluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-4- (dimethylamino)but-2-enamide | IH | 4-(Dimethylamino)but-2-enamide, (S,E)-N-(4-((3,4- difluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-; Afatinib Difluoro Analog; | 25MG,50MG | NA | NA | 469.48 | C24H25F2N5O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00362 | (S,E)-N-(4-((4-Chloro-3- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)but-2- enamide | IH | But-2-enamide, (S,E)-N-(4-((4- chloro-3-fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl); | 25MG,50MG | NA | NA | 442.87 | C22H20ClFN4O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00363 | (S,E)-N-(4-((3,4- Dichlorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-4- (dimethylamino)but-2-enamide | IH | 4-(Dimethylamino)but-2-enamide, (S,E)-N-(4-((3,4- dichlorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-; Afatinib Dichloro Analog; | 25MG,50MG | NA | NA | 502.39 | C24H25Cl2N5O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00364 | (S,E)-4-Bromo-N-(4-((3-chloro-4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)but-2- enamide | IH | But-2-enamide, (S,E)-4-bromo-N- (4-((3-chloro-4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl); | 25MG,50MG | NA | NA | 521.77 | C22H19BrClFN4O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00365 | (S,E)-4-(Dimethylamino)-N-(4- hydroxy-7-((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)but-2- enamide | IH | But-2-enamide, (S,E)-4- (dimethylamino)-N-(4-hydroxy-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl); Afatinib 4- keto Analog; | 25MG,50MG | NA | NA | 358.39 | C18H22N4O4 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00366 | (S,E)-N-(4-((3-Chloro-4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-4- (methylamino)but-2-enamide | IH | But-2-enamide, (S,E)-N-(4-((3- chloro-4-fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-4- (methylamino); N-Desmethyl Afatinib; Afatinib N-Desmethyl; | 25MG,50MG | NA | NA | 471.91 | C23H23ClFN5O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00367 | Afatinib N-Oxide | IH | (S,E)-4-((4-((3-Chloro-4- fluorophenyl)amino)-7- ((tetrahydrofuran-2- yl)oxy)quinazolin-6-yl)amino)-N,Ndimethyl-4-oxobut-2-en-1-amine Oxide; | 25MG,50MG | NA | NA | 501.94 | C24H25ClFN5O4 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00368 | (E)-N-(4-((3-Chloro-4- fluorophenyl)amino)-7- ethoxyquinazolin-6-yl)-4- (dimethylamino)but-2-enamide | IH | But-2-enamide, (E)-N-(4-((3- chloro-4-fluorophenyl)amino)-7- ethoxyquinazolin-6-yl)-4- (dimethylamino); Afatinib O-Ethyl Analog; |
25MG,50MG | NA | NA | 443.9 | C22H23ClFN5O2 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00369 | (E)-N-(4-((3-Chloro-4- fluorophenyl)amino)-7- methoxyquinazolin-6-yl)-4- (dimethylamino)but-2-enamide | IH | But-2-enamide, (E)-N-(4-((3- chloro-4-fluorophenyl)amino)-7- methoxyquinazolin-6-yl)-4- (dimethylamino); Afatinib OMethyl Analog; | 25MG,50MG | NA | NA | 429.88 | C21H21ClFN5O2 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00370 | (S)-N-(4-((4-Fluorophenyl)amino)- 7-((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)formamide | IH | Formamide, (S)-N-(4-((4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl); Afatinib NFormoyl Analog; | 25MG,50MG | NA | NA | 368.36 | C19H17FN4O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00371 | (S,E)-N-(4-((3-Chloro-4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-4- hydroxybut-2-enamide | IH | 4-Hydroxybut-2-enamide, (S,E)-N- (4-((3-chloro-4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)-; Afatinib 4- Hydroxy-2-butenoic Acid Anlog; | 25MG,50MG | NA | NA | 458.87 | C22H20ClFN4O4 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00372 | (S)-N-(4-((3-Chloro-4- fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl)but-3- enamide | IH | But-3-enamide, (S)-N-(4-((3- chloro-4-fluorophenyl)amino)-7- ((tetrahydrofuran-3- yl)oxy)quinazolin-6-yl); Afatinib 3- Butenoic Acid Analog; | 25MG,50MG | NA | NA | 442.87 | C22H20ClFN4O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00373 | N-(3-Chloro-4-fluorophenyl)-7- methoxy-6-nitroquinazolin-4-amine | IH | N-(3-Chloro-4-fluorophenyl)-7- methoxy-6-nitro-4- quinazolinamine; Afatinib Nitro Methoxy Analog; | 25MG,50MG | NA | 179552-74-0 | 348.72 | C15H10ClFN4O3 | NA | Afatinib – In house impurity |
ADI-IMPM-01-00374 | Afatinib Dimaleate | API | (2E)-N-[4-[(3-Chloro-4- fluorophenyl)amino]-7-[[(3S)- tetrahydro-3-furanyl]oxy]-6- quinazolinyl]-4-(dimethylamino)-2- butenamide (2Z)-2-butenedioate; | 25MG,50MG | Refrigerat or | 850140-73-7 | 718.09 | C32H33ClFN5O11 | NA | Afatinib Dimaleate – API |
ADI-IMPM-01-00375 | 25MG,50MG | NA | ||||||||
ADI-IMPM-01-00376 | Aflatoxin | API | Aflatoxin B1; (6aR,9aS)-2,3,6a,9aTetrahydro-4-methoxy-1H,11Hcyclopenta[c]furo[3’,2’:4,5]furo[2,3h][1]benzopyran-1,11-dione | 25MG,50MG | Freezer | 1162-65-8 | 312.27 | C17H12O7 | (-)-Aflatoxin B1; AFB1; NSC 529592; | Aflatoxin – API |
ADI-IMPM-01-00377 | AFB-Guanine Acetic Acid Salt | IH | (6aS,8R,9R,9aR)-8-(2-Amino-1,6dihydro-6-oxo-7H-purin-7-yl)2,3,6a,8,9,9a-hexahydro-9-hydroxy-4methoxycyclopenta[c]furo[3′,2′:4,5]furo[2,3h][1]benzopyran-1,11-dione Acetic Acid; | 25MG,50MG | Freezer | NA | 539.45 | C17H12O7 | NA | Aflatoxin – In house impurity |
ADI-IMPM-01-00378 | Aflatoxin Q1 | IH | (3S,6aR,9aS)-2,3,6a,9aTetrahydro-3-hydroxy-4methoxycyclopenta[c]furo[3′,2′:4, 5]furo[2,3-h][1]benzopyran-1,11dione | 25MG,50MG | Freezer | 52819-96-2 | 328.27 | C17H12O7 | [3S-(3α,6aα,9aα)]-2,3,6a,9aTetrahydro-3-hydroxy-4methoxycyclopenta[c]furo[3′, 2′:4,5]furo[2,3h][1]benzopyran-1,11-dione | Aflatoxin – In house impurity |
ADI-IMPM-01-00379 | epi-Aflatoxin Q1 | IH | [3R-(3α,6aα,9aα)]-2,3,6a,9aTetrahydro-3-hydroxy-4- methoxycyclopenta[c]furo[3′,2′:4, 5]furo[2,3-h][1]benzopyran-1,11dione | 25MG,50MG | NA | 56648-94-3 | 328.27 | C17H12O7 | NA | Aflatoxin – In house impurity |
ADI-IMPM-01-00380 | Aflatoxin G1 | IH | (7aR,10aS)-3,4,7a,10a-Tetrahydro-5methoxy-1H,12H-furo[3’,2’:4,5]furo[2,3h]pyrano[3,4-c][1]benzopyran-1,12dione; | 25MG,50MG | Freezer, Under Inert Atmosphere | 1165-39-5 | 328.27 | C17H12O7 | NA | Aflatoxin – In house impurity |
ADI-IMPM-01-00381 | Aflatoxin G2 | IH | (7aR,10aS)-3,4,7a,9,10,10a-Hexahydro5-methoxy-1H,12H-furo[3′,2′:4,5]furo[2,3h]pyrano[3,4-c][1]benzopyran-1,12dione; Dihydroaflatoxin G1 | 25MG,50MG | Freezer, Under Inert Atmosphere | 7241-98-7 | 330.29 | C17H14O7 | NA | Aflatoxin – In house impurity |
ADI-IMPM-01-00382 | Aflatoxin M1 | IH | (6aR,9aR)-2,3,6a,9a-Tetrahydro-9ahydroxy-4-methoxycyclopenta[c]furo[3’,2’:4,5]furo[2,3h][1]benzopyran-1,11-dione; AFM1 | 25MG,50MG | Freezer | 6795-23-9 | 328.27 | C17H12O7 | NA | Aflatoxin – In house impurity |
ADI-IMPM-01-00383 | Aflatoxin M2 | IH | 2,3,6a,8,9,9a-Hexahydro-9a-hydroxy-4methoxycyclopenta[c]furo[3’,2’:4,5]furo[2 ,3-h][1]benzopyran-1,11-dione; | 25MG,50MG | Freezer | 6885-57-0 | 330.29 | C17H14O7 | NA | Aflatoxin – In house impurity |
ADI-IMPM-01-00384 | Aflatoxin P1 | IH | (6aR,9aS)-2,3,6a,9a-Tetrahydro-4hydroxycyclopenta[c]furo[3’,2’:4,5]furo[2, 3-h][1]benzopyran-1,11-dione | 25MG,50MG | Freezer | 32215-02-4 | 298.25 | C16H10O6 | NA | Aflatoxin – In house impurity |
ADI-IMPM-01-00385 | Aflatoxin P2 | IH | (6aR,9aS)-2,3,6a,8,9,9a-Hexahydro-4hydroxycyclopenta[c]furo[3′,2′:4,5]furo[2,3h][1]benzopyran-1,11-dione; | 25MG,50MG | NA | 891197-67-4 | 300.26 | C16H12O6 | NA | Aflatoxin – In house impurity |
ADI-IMPM-01-00386 | Aflatoxin B2 | IH | (6aR,9aS)-2,3,6a,8,9,9aHexahydro-4methoxycyclopenta[c]furo[3’,2’:4, 5]furo[2,3-h][1]benzopyran-1,11dione; Dihydroaflatoxin B1; Dihydroaflatoxine B1 | 25MG,50MG | Freezer, Under Inert Atmosphere | 7220-81-7 | 314.29 | C17H14O6 | NA | Aflatoxin – In house impurity |
ADI-IMPM-01-00387 | Afloqualone | API | 6-Amino-2-(fluoromethyl)-3-(2methylphenyl)-quinazolin-4-one | 25MG,50MG | NA | 56287-74-2 | 283.3 | C16H14FN30 | NA | Afloqualone – API |
ADI-IMPM-01-00388 | Afloqualone Nitro Impurity | IH | 2-(Fluoromethyl)-6-nitro-3-(otolyl)-4(3H)-quinazolinone; | 25MG,50MG | NA | NA | 313.28 | C16H12FN303 | NA | Aflatoxin – In house impurity |
ADI-IMPM-01-00389 | Agmatine | API | N-(4-Aminobutyl)guanidine; 1-(4Aminobutyl)guanidine | 25MG,50MG | NA | 306-60-5 | 130.19 | C5H14N4 | NA | Afloqualone – API |
ADI-IMPM-01-00390 | Agmatine Sulfate | API | 1-(4-Aminobutyl)guanidine Sulfate; 1-Amino-4guanidinobutane Sulfate Salt; 4Guanidinobutylamine Sulfate | 25MG,50MG | room temp | 2482-00-0 | 228.27 | C5H16N404S | N-(4-Aminobutyl)guanidine Sulfate; | Agmatine Sulfate – API |
ADI-IMPM-01-00391 | Agomelatine | API | N-[2-(7-Methoxy-1naphthalenyl)ethyl]acetamide; N-[2-(7Methoxy-1-naphthyl) ethyl]acetamide; S 20098; Valdoxan; | 25MG,50MG | freezer | 138112-76-2 | 243.3 | C15H17NO2 | NA | Agomelatine – API |
ADI-IMPM-01-00392 | Agomelatine Dimer Acetamide | IH | N,N-Bis[2-(7-methoxy-1naphthalenyl)ethyl]acetamide; | 25MG,50MG | NA | 1385018-58-5 | 427.53 | C28H29N03 | NA | Agomelatine – In house impurity |
ADI-IMPM-01-00393 | Agomelatine Dimer Urea | IH | N,N’-Bis[2-(7-methoxy-1naphthalenyl)ethyl]urea | 25MG,50MG | NA | 185421-27-6 | 428.52 | C3H7NO2 | NA | Agomelatine – In house impurity |
ADI-IMPM-01-00394 | Desacetyl-7-desmethyl Agomelatine Hydrobromide | IH | 8-(2-Aminoethyl)-2-naphthalenol Hydrobromide | 25MG,50MG | NA | 144705-51-1 | 268.15 | C3H7NO2 | NA | Agomelatine – In house impurity |
ADI-IMPM-01-00395 | Alanine | API | DL-Alanine; (R,S)-Alanine; (±)-2Aminopropionic Acid; (±)-Alanine | 25MG,50MG | Refrigerator | 302-72-7 | 89.09 | C3H7NO2 | DL-Ala; DL-α-Alanine; DL-αAminopropionic acid; NSC 7602; dl2-Aminopropanoic Acid; dlAlanine | Alanine – API |
ADI-IMPM-01-00396 | Albendazole | API | N-[6-(Propylthio)-1H-benzimidazol-2yl]carbamic Acid Methyl Ester; [5(Propylthio)-1H-benzimidazol-2yl]carbamic Acid Methyl Ester; Albenza; Andazol | 25MG,50MG | freezer | 54965-21-8 | 265.33 | C12H15N3O2S | Ashialben; Atasol; Bruzol; Eskazole; Loveral; Lurdex; Proftril; Valbazen; Zentel; NSC 220008; Tobend; Valbazen; Vermisen; Vermitan; Vermizole; Zentel | Albendazole – API |
ADI-IMPM-01-00397 | Amino Albendazole | Imp A | 5-(Propylsulphanyl)-1H-benzimidazol-2amine; Desmethoxycarbonyl Albendazole, | 25MG,50MG | NA | 80983-36-4 | 207.3 | C12H15N3O3S | 5-(Propylthio)-1H-benzimidazol-2amine; Albendazole Amine; 5(Propylsulphanyl)-1H-benzimidazol2-amine | Albendazole – Impurity A |
ADI-IMPM-01-00398 | Albendazole Sulfoxide | Imp B | Methyl[5-Propylsulphonyl)-1Hbenzimidazol-2-yl]carbamate; Albendazole Oxide | 25MG,50MG | freezer | 54029-12-8 | 281.33 | C12H15N3O3S | Ricobendazole; RS-8852 | Albendazole – Impurity B |
ADI-IMPM-01-00399 | Albendazole Sulfone | Imp C | Methyl[5-Propylsulphonyl)-1Hbenzimidazol-2-yl]carbamate | 25MG,50MG | freezer | 75184-71-3 | 297.33 | C12H15N3O4S | N-[6-(Propylsulfonyl)-1Hbenzimidazol-2-yl]carbamic Acid Methyl Ester; | Albendazole – Impurity C |
ADI-IMPM-01-00400 | Amino Albendazole Sulfone | Imp D | 5-(Propylsulphonyl)-1H-benzimidazol-2amine; 6-(Propylsulfonyl)-1Hbenzimidazol-2-amine | 25MG,50MG | freezer | 80983-34-2 | 239.29 | C9H9N3O2 | Albendazole-2-aminosulfone; SKF 81038; | Albendazole – Impurity D |
ADI-IMPM-01-00401 | Methyl (1H-Benzimidazol-2-yl)carbamate | Imp E | N-1H-Benzimidazol-2-yl-carbamic Acid Methyl Ester; Carbendazim; Mercarzole; Carbendazole; | 25MG,50MG | Refrigerator | 10605-21-7 | 191.19 | C9H9N3O2 | 2-Benzimidazolecarbamic Acid Methyl Ester; Carbendazole; BMC; MBC; BCM; BAS-3460; BAS67054; CTR-6669; | Albendazole – Impurity E |
ADI-IMPM-01-00402 | Methyl [5-(methylsulphanyl)-1Hbenzimidazol-2-yl]carbamate | Imp F | Methyl (5-(methylthio)-1Hbenzo[d]imidazol-2-yl)carbamate; | 25MG,50MG | NA | NA | 237.28 | C10H11N302S | NA | Albendazole – Impurity F |
ADI-IMPM-01-00403 | 4-(Propylthio)benzene-1,2-diamine | IH | Albendazole Impurity 1; 4-(Propylthio)1,2-phenylenediamine; 1,2BenzenediaMine, 4-(propylthio)-; | 25MG,50MG | NA | 66608-52-4 | 182.29 | C9H14N2S | NA | Albendazole – In house impurity |
ADI-IMPM-01-00404 | Methylcyanocarbamate | IH | Methyl Cyanocarbamate; Methyl N-cyanocarbamate; Albendazole Impurity 7 | 25MG,50MG | NA | 21729-98-6 | 100.08 | C7H5N3O2S | Cyano-carbamic Acid Methyl Ester; N-cyanocarbamic Acid Methyl Ester; | Albendazole – In house impurity |
ADI-IMPM-01-00405 | 2-Nitro-4-thiocyanato Aniline | IH | 4-Amino-3-nitrophenyl Thiocyanate; 2-Nitro-4thiocyanatobenzenamine; 2-Nitro4-Thiocyanatoaniline | 25MG,50MG | Refrigerator | 54029-45-7 | 195.2 | C7H5N3O2S | 4-Thiocyanato-2-nitroaniline; 2-Nitro-4-tiociano Anilina | Albendazole – In house impurity |
ADI-IMPM-01-00406 | 2-Nitro-4-(propylthio)aniline | IH | 2-Nitro-4(propylthio)benzenamine; Albendazole Impurity 3; | 25MG,50MG | NA | 54393-89-4 | 212.27 | C9H12N2O2S | NA | Albendazole – In house impurity |
ADI-IMPM-01-00407 | Albuterol Sulfate | API | Salbutamol Sulphate; α1-[[(1,1Dimethylethyl)amino]methyl]-4-hydroxy1,3-benzenedimethanol Sulfate; Aerolin; 4-(2-(tert-Butylamino)-1-hydroxyethyl)-2(hydroxymethyl)phenol Hemisulfate | 25MG,50MG | freezer | 51022-70-9 | 576.7 | C26H44N2O10S | Albuterol Hemisulfate; Asmaven; Cobutolin; Ecovent; Loftan; Proventyl; Salbulin; Salbumol; Salbutamol Sulfate; Ventorline CR; Volma; dl-Salbutamol Sulfate; | Albuterol Sulfate – API |
ADI-IMPM-01-00408 | Salbutamol Deshydroxy Impurity | Imp C | (1RS)-2-[(1,1-Dimethylethyl)amino]-1-(4hydroxy-3-methylphenyl)ethanol; 3Dehydroxy Salbutamol; 4-[2-[(1,1Dimethylethyl)amino]-1-hydroxyethyl]-2methylphenol; | 25MG,50MG | Refrigerator | 18910-68-4 | 223.31 | C13H21NO2 | α-[[(1,1Dimethylethyl)amino]methyl]-4hydroxy-3methylbenzenemethanol; Albuterol Related Compound B; Levalbuterol Related Compound B; | albuterol Sulfate – Impurity |
ADI-IMPM-01-00409 | N-Benzyl Albuterol | Imp E | α1-[[(1,1Dimethylethyl)(phenylmethyl)amino]meth yl]-4-hydroxy-1,3-benzenedimethanol; 1(4-Hydroxy-3-hydroxymethylphenyl)-2(tert-butylbenzylamino)ethanol; (1RS)-2[Benzyl(1,1-dimethylethyl)amino]-1-[4hydroxy-3(hydroxymethyl)phenyl]ethanol; | 25MG,50MG | NA | 24085-03-8 | 329.43 | C20H27NO3 | α1-Benzyl-tert-butylaminomethyl-4hydroxy-m-xylene-α1,α3-diol; 1-(4Hydroxy-3-hydroxymethylphenyl)-2(tert-butylbenzylamino)ethanol; α1[(Benzyl-tert-butylamino)methyl]-4hydroxy-m-xylene-α,α’-diol; | albuterol Sulfate – Impurity |
ADI-IMPM-01-00410 | 4-[2-[(1,1-Dimethylethyl)amino]ethyl]-2methylphenol | Imp H | 4-tert-Butylaminoethyl-2-methylphenol | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 132183-64-3 | 207.31 | C13H21NO | NA | albuterol Sulfate – Impurity |
ADI-IMPM-01-00411 | Alcaftadine | API | 6,11-Dihydro-11-(1-methyl-4piperidinylidene)-5H-imidazo[2,1b][3]benzazepine-3-carboxaldehyde; R 89674; | 25MG,50MG | NA | 147084-10-4 | 307.39 | C19H21N30 | NA | alcafladine -API |
ADI-IMPM-01-00412 | Alclometasone Dipropionate | API | Alclometasone 17,21-Dipropionate; Aclovate; Almeta; Delonal; Sch 22219; Vaderm | 25MG,50MG | NA | 66734-13-2 | 521.04 | C28H37CI07 | 7α,11β,16α)-7-Chloro-11-hydroxy16-methyl-17,21-bis(1oxopropoxy)pregna-1,4-diene-3,20dione | Alclometasone Dipropionate – API |
ADI-IMPM-01-00413 | 11β,17,21-Trihydroxy-16α-methylpregna1,4-diene-3,20-dione 17,21-Dipropionate | IH | (8S,9S,10R,11S,13S,14S,16R,17R)-11Hydroxy-10,13,16-trimethyl-3-oxo-17-(2(propionyloxy)acetyl)6,7,8,9,10,11,12,13,14,15,16,17dodecahydro-3Hcyclopenta[a]phenanthren-17-yl Propionate; | 25MG,50MG | NA | 71868-53-6 | 486.6 | C28H38O7 | Alclometasone Dipropionate Related Compound A; | Alclometasone Dipropionate – In house impurity |
ADI-IMPM-01-00414 | Aldosterone | API | (11β)-11,21-Dihydroxy-3,20-dioxopregn4-en-18-al | 25MG,50MG | NA | 2827-21-6 | 360.44 | C21H28O5 | 11β,21-Dihydroxypregn-4-ene3,18,20-trione; 18-Formyl-11β,21dihydroxy -4-pregnene-3,20-dione; 18-Oxocorticosterone; Aldocorten; Aldocortene; Aldocortin; Electrocortin; Elektrocortin; NSC 73856; Reichstein X; | Aldosterone – API |
ADI-IMPM-01-00415 | Aldosterone 21-Acetate | IH | Aldosterone 21-Monoacetate; (11β)-21(Acetyloxy)-11,18-epoxy-18-hydroxypregn-4-ene-3,20-dione | 25MG,50MG | Refrigerator | 2827-21-6 | 402.48 | C23H30O6 | NA | Aldosterone – In house impurity |
ADI-IMPM-01-00416 | Aldosterone 18-Oxime 21-Acetate | IH | Aldosterone Oxime 21-Acetate; (11β)-21(Acetyloxy)-11-hydroxy-3,20-dioxo-pregn4-en-18-al 18-Oxime; | 25MG,50MG | NA | 74220-49-8 | 417.5 | C23H31NO6 | NA | Aldosterone – In house impurity |
ADI-IMPM-01-00417 | Canrenone | IH | (17α)-17-Hydroxy-3-oxo-pregna-4,6diene-21-carboxylic Acid γ-Lactone; | 25MG,50MG | freezer | 976-71-6 | 340.46 | C22H28O3 | 17α-2-Carboxyethyl-17βhydroxyandrosta-4,6-dien-3-one Lactone; Phanurane | Aldosterone – In house impurity |
ADI-IMPM-01-00418 | Δ9-Canrenone | IH | 17β-Hydroxy-4,6,9(11)-trien-3-one 21carboxylic Acid γ-Lactone; Δ9-11Canrenone | 25MG,50MG | NA | 95716-71-5 | 338.44 | C22H26O3 | NA | Aldosterone – In house impurity |
ADI-IMPM-01-00419 | Canrenoic Acid Potassium Salt | IH | (17α)-17-Hydroxy-3-oxopregna-4,6diene-21-carboxylic Acid Potassium Salt; Potassium β-(3-Oxo-17βhydroxyandrosta-4,6-dien-17α-yl) Propionate; SC 14266; SC 14266/371; Soldactona; Soldactone; Soludactone; Venactone; Potassium Aldadiene; | 25MG,50MG | Refrigerator | 2181-04-6 | 396.56 | C22H29K04 | Aldadiene Kalium; Aldadiene Potassium; CB 8109; Canrenoate Potassium; Kanrenol; MF 465 a; Potassium 17-Hydroxy-3-oxo-17αpregna-4,6-diene-21-carboxylate; Potassium 3-(17β-Hydroxy-3oxoandrosta-4,6-dien-17yl | Aldosterone – In house impurity |
ADI-IMPM-01-00420 | (17α)-7-Cyano-17-hydroxy-3-oxo-pregna4,9(11)-diene-21-carboxylic acid γLactone | IH | (17α)-7-Cyano-17-hydroxy-3-oxo-pregna4,9(11)-diene-21-carboxylic acid γLactone | 25MG,50MG | NA | 76959-24-5 | 365.47 | C23H27NO3 | NA | Aldosterone – In house impurity |
ADI-IMPM-01-00421 | 1-Dehydro Aldosterone | IH | (11β)-11,21-Dihydroxy-3,20dioxopregna-1,4-dien-18-al; Δ1Aldosterone; | 25MG,50MG | NA | 76959-24-5 | 358.43 | C21H26O5 | 11β,21-Dihydroxy-3,20dioxopregna-1,4-dien-18-al; 1Dehydroaldosterone | Aldosterone – In house impurity |
ADI-IMPM-01-00422 | 11-Deoxy Corticosterone | IH | 21-Hydroxypregn-4-ene-3,20-dione | 25MG,50MG | Refrigerator | 64-85-7 | 330.46 | C21H30O3 | 11-Deoxycorticosterone; 11Dehydroxy- corticosterone; 11Desoxycorticosterone; 21-Hydroxy3,20-dioxopregn -4-ene; 21Hydroxy-4-pregnane-3,20-dione; 21-Hydroxyprogesterone; Cortexone; DOC; Deoxycortone; Desoxycorticosterone; | Aldosterone – In house impurity |
ADI-IMPM-01-00423 | 3β,5-Dihydroxy-15β,16β-methylene-5βandrost-6-en-17-one | IH | (3β,5β,15α,16α)-15,16-Dihydro-3,5dihydroxy-3’H-cycloprop[15,16]androsta6,15-dien-17-one | 25MG,50MG | Refrigerator | 82543-15-5 | 316.43 | C20H28O3 | 15β,16β-Methylene-3β,5βdihydroxyandrost-6-en-17-one | Aldosterone – In house impurity |
ADI-IMPM-01-00424 | Eplerenone | IH | (7α,11α,17α)-9,11-Epoxy-17-hydroxy-3oxopregn-4-ene-7,21-dicarboxylic Acid | 25MG,50MG | freezer | 107724-20-9 | 414.49 | C24H30O6 | γ-Lactone 7-Methyl Ester; CGP 30083; Epoxymexrenone; Inspra; SC-66110; | Aldosterone – In house impurity |
ADI-IMPM-01-00425 | 18-Hydroxy Corticosterone IH | IH | (11β)-11,18,21-Trihydroxypregn-4-ene3,20-dione; | 25MG,50MG | NA | 561-65-9 | 362.46 | C21H30O5 | 11β,18,21-Trihydroxypregn-4-ene3,20-dione; 18Hydroxycorticosterone | Aldosterone – In house impurity |
ADI-IMPM-01-00426 | Spironolactone | IH | (7α,7α)-7-(Acetylthyo)-17-hydroxy-3oxopregn-4-one-21-carboxylic Acid γLactone; | 25MG,50MG | Refrigerator | 52-01-7 | 416.57 | C24H32O4S | 7α-Acetylthio-3-oxo-17α-pregn-4ene-21,17-carbolactone; SC-9420; Adactone; | Aldosterone – In house impurity |
ADI-IMPM-01-00427 | Tetrahydro Aldosterone | IH | (3α,5β,11β)-11,18-Epoxy-3,18,21trihydroxypregnan-20-one; | 25MG,50MG | NA | 13489-75-3 | 364.48 | C21H32O5 | 11β,18-Epoxy-3α,18,21-Τrihydroxy5β-pregnan-20-one; 3α,5βTetrahydro- aldosterone; Tetrahydroaldosterone | Aldosterone – In house impurity |
ADI-IMPM-01-00428 | Alendronic Acid | API | 4-Amino-1-hydroxybutane-1,1diphosphonic Acid; (4-Amino-1hydroxybutylidene)bisphosphonic Acid; | 25MG,50MG | NA | 66376-36-1 | 249.1 | C4H13NO7P2 | NA | Alendronic Acid – API |
ADI-IMPM-01-00429 | Aleuritic acid | API | (9R,10S)-rel-9,10,16Trihydroxyhexadecanoic acid; | 25MG,50MG | NA | 533-87-9 | 304.43 | C16H32O5 | 9,10,16-Trihydroxyhexadecanoic acid; Aleuritolic acid | Aleuritic acid – API |
ADI-IMPM-01-00430 | Alfacalcidol | API | 5-[(2E)-2-[(1R,3aS,7aR)-1-[(1R)-1,5Dimethylhexyl]octahydro-7a-methyl- 4Hinden-4-ylidene]ethylidene]-4-methylene1,3-cyclohexanediol | 25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphere | 41294-56-8 | 400.64 | 41294-56-8 | 1-α-Hydroxycholecalciferol; 1-αHydroxyvitamin D3; Alpharol; Alpha D3; Etalpha; Oxydevit; 1Hydroxyvitamin D3; | alcadcidol-API |
ADI-IMPM-01-00431 | Alfentanil Hydrochloride | API | N-(1-(2-(4-Ethyl-5-oxo-4,5dihydro-1H-tetrazol-1-yl)ethyl)-4(methoxymethyl)piperidin-4-yl)-Nphenylpropionamide Hydrochloride; | 25MG,50MG | NA | 69049-06-5 | 452.98 | C21H33ClN6O3 | N-[1-[2-(4-Ethyl-4,5-dihydro5-oxo-1H-tetrazol-1-yl)ethyl]4-(methoxymethyl)piperidin4-yl]-N-phenylpropanamide Hydrochloride; | Alfentanil Hydrochloride – API |
ADI-IMPM-01-00432 | 1-Ethyltetrazolinone | IH | 1-Ethyl-1,2-dihydro-5H-tetrazol-5one; 1-Ethyl-1H-tetrazol-5-ol; 1Ethyl-1H-tetrazol-5(4H)-one | 25MG,50MG | Refrigerat or | 69048-98-2 | 114.11 | C3H6N4O | NA | Alfentanil Hydrochloride – In house impurity |
ADI-IMPM-01-00433 | Alfuzosin Hydrochloride | API | N-[3-[(4-Amino-6,7-dimethoxy-2quinazolynyl)methylamino]propyl]tetrahy dro-2-furancarboxamide | 25MG,50MG | freezer | 81403-68-1 | 425.91 | C19H28ClN5O4 | Alfoten; SL 77-499-10; SL 7749910; Urion; Uroxatral; Xatral | Alfuzosin Hydrochloride – API |
ADI-IMPM-01-00434 | 2,3,4,5-Tetradehydro Alfuzosin Hydrochloride | Imp A | N-[3-[(4-Amino-6,7-dimethoxy-2quinazolinyl)methylamino]propyl]-2furancarboxamide Hydrochloride | 25MG,50MG | NA | 98902-29-5 | 421.88 | C19H24ClN5O4 | NA | Alfuzosin Hydrochloride – Impurity A |
ADI-IMPM-01-00435 | 4-Amino-2-chloro-6,7dimethoxyquinazoline | ImpB | 2-Chloro-6,7-dimethoxy-4quinazolinamine; | 25MG,50MG | freezer | 23680-84-4 | 239.66 | C10H10ClN3O2 | NA | Alfuzosin Hydrochloride – Impurity B |
ADI-IMPM-01-00436 | N2-Methyl Alfuzosin Hydrochloride | Imp C | (RS)-N-[3-[(4-Amino-6,7-dimethoxy-2quinazolinyl)amino]propyl]tetrahydro-Nmethyl-2-furancarboxamide Hydrochloride | 25MG,50MG | NA | 72104-34-8 | 425.91 | C19H28ClN5O4 | NA | Alfuzosin Hydrochloride – Impurity C |
ADI-IMPM-01-00437 | N-(4-Amino-6,7-dimethoxyquinazol-2-yl)-Nmethylpropylenediamine Hydrochloride | Imp D | N2-(3-Aminopropyl)-6,7-dimethoxy-N2methyl-2,4-quinazolinediamine Hydrochloride; | 25MG,50MG | NA | 81403-69-2 | 327.81 | C14H22ClN5O2 | Alfuzosin Related Compound D; | Alfuzosin Hydrochloride – Impurity D |
ADI-IMPM-01-00438 | N-(4-Amino-6,7-dimethoxyquinazol-2-yl)-Nmethylpropylenediamine Formamide Hydrochloride | Imp E | N[3-[(4-Amino-6,7-dimethoxyquinaolin-2yl)methylamino]propyl]formamide Hydrochloride | 25MG,50MG | NA | 1026411-59-5 | 355.82 | C14H17N5O2 | NA | Alfuzosin Hydrochloride – Impurity E |
ADI-IMPM-01-00439 | Algestone | API | (16α)-16,17-Dihydroxy-pregn-4-ene-3,20dione; 16α,17-Dihydroxyprogesterone; 16α,17α-Dihydroxypregn-4-ene-3,20dione | 25MG,50MG | NA | 595-77-7 | 346.46 | C21H30O4 | 4-Pregnen-16α,17α-diol-3,20dione; Alfasone; Alphasone | Algestone – API |
ADI-IMPM-01-00440 | Acetonide Dihydroxyprogesterone | IH | (6aR,6bS,8aS,8bS,11aR,12aS,12bR)-8bAcetyl-6a,8a,10,10-tetramethyl5,6,6a,6b,7,8,8a,8b,11a,12,12a,12bdodecahydro-1Hnaphtho[2′,1′:4,5]indeno[1,2-d][1,3]dioxol4(2H)-one; Algestone Acetonide; 16α,17αIsopropylidenedioxyprogesterone; Alphasone acetonide; Progesterone 16,17-acetonide; W 3395; (16α)-16,17[(1-Methylethylidene)bis(oxy)]-pregn-4 | 25MG,50MG | Refreigerator | 4968-09-6 | 386.52 | C24H34O4 | 16α,17-dihydroxy-Pregn-4-ene3,20-dione cyclic acetal with acetone (7CI,8CI); Progesterone, 16α,17-dihydroxy-, cyclic acetal with acetone (6CI); (16α)-16,17-[(1Methylethylidene)bis(oxy)]pregn-4ene-3,20-dione; 16α,17(Isopropylidenedioxy)progesterone ; 16α,17-Dihydroxypregn-4-ene3,20-dione cyclic acetal with acetone; | Algestone – In house impurity |
ADI-IMPM-01-00441 | Algestone Acetophenide | IH | Alphasone Acetophenide; Deladroxone; Dihydroxyprogesterone Acetophenide; Droxone; Neolutin Depositum; 2HNaphth[1’,2’:6,7]indeno[1,2d][1,3]dioxole, Pregn-4-ene-3, | 25MG,50MG | Refreigerator | 24356-94-3 | 448.59 | C24H34O4 | [16α(R)]-16,17-[(1Phenylethylidene)bis(oxy)]pregn-4-ene-3,20-dione | Algestone – In house impurity |
ADI-IMPM-01-00442 | Allantoin | API | (RS)-(2,5-Dioxoimidazolidin-4yl)urea; 5-Ureidohydantoin; (2,5Dioxo-4-imidazolidinyl)urea; Allantol; | 25MG,50MG | Refregerator | 97-59-6 | 158.12 | C4H6N4O3 | Cordianine; Glyoxyldiureid; Glyoxyldiureide; Glyoxylic Diureide; NSC 7606; Psoralon; Sebical; Septalan | Allantoin – API |
ADI-IMPM-01-00443 | Allobarbital | API | 5,5-Diallybarbituric acid; 5,5-Di-2propenyl2,4,6(1H,3H,5H)pyrimidinetrione; Allobarbitone | 25MG,50MG | NA | 52-43-7 | 208.21 | C10H12N2O3 | NA | Allobarbital – API |
ADI-IMPM-01-00444 | Allopurinol | API | 1,5-Dihydro-4H-pyrazolo[3,4-d]pyrimidin4-one; 1H-Pyrazolo(3,4-d)pyrimidin-4-ol; 4-Hydroxypyrazolo(3,4-d)pyrimidine; 4Hydroxypyrazolo[3,4-d]pyrimidine; HPP | 25MG,50MG | Refregerator | 315.30-0 | 136.11 | C5H4N4O | 4-Hydroxypyrazolo[3,4d]pyrimidine; 4-Oxopyrazolo[3,4d]pyrimidine; Adenock; Allopur; Caplenal; Cellidrin; NSC 101655; NSC 1390; | Allopurinol-API |
ADI-IMPM-01-00445 | 3-Amino-4-carbamoylpyrazole Hemisulfate | Imp A | 3-Amino-Pyrazole-4-carboxamide Hemisulfate; Allopurinol Related Compound A; | 25MG,50MG | freezer | 27511-79-1 | 175.16 | C4H6N4O•1/2H2O4S | 5-Amino-1H-pyrazole-4-carboxylic acid amide; | Allopurinol – Impurity A |
ADI-IMPM-01-00446 | 3-(Formylamino)-1H-pyrazole-4carboxamide | Imp B | 5-Formylamino-1H-pyrazole-4-carboxylic Acid Amide; | 25MG,50MG | NA | 22407-20-1 | 154.13 | C5H6N4O2 | Allopurinol Related Compound B; | Allopurinol – Impurity B |
ADI-IMPM-01-00447 | 3-(4H-1,2,4-Triazol-4-yl)-1H-pyrazole-4carboxamide | Imp C | 5-[1,2,4]Triazol-4-yl-1H-pyrazole-4carboxylic Acid Amide; | 25MG,50MG | NA | 1346604-13-4 | 178.15 | C6H6N60 | Allopurinol Related Compound C | Allopurinol – Impurity C |
ADI-IMPM-01-00448 | Ethyl 3-Amino-4-pyrazolecarboxylate | Imp D | 5-Amino-1H-pyrazole-4-carboxylic Acid Ethyl Ester; | 25MG,50MG | Amber Vial, Freezer | 6994.25-8 | 155.15 | C6H9N302 | Allopurinol Related Compound D | Allopurinol – Impurity D |
ADI-IMPM-01-00449 | 3-(Formylamino)-1H-pyrazole-4-carboxylic Acid Ethyl Ester | Imp E | 5-Formylamino-1H-pyrazole-4carboxylic acid Ethyl Ester; | 25MG,50MG | NA | 31055-19-3 | 183.16 | C7H9N303 | 3-Formamidopyrazole-4carboxylic Acid Ethyl Ester; Ethyl 3(Formylamino)-1H-pyrazole-4carboxylate; Allopurinol Impurity E; | Allopurinol – Impurity E |
ADI-IMPM-01-00450 | (E/Z)-3-[(2-Cyano-3-ethoxy-3-oxo-1propenyl)amino]-1H-Pyrazole-4-carboxylic Acid Ethyl Ester | Imp F | 3-[(2-Cyano-3-ethoxy-3-oxo-1-propen-1yl)amino]-1H-pyrazole-4-carboxylic Acid Ethyl Ester | 25MG,50MG | NA | 321571-07-7 | 278.26 | C12H14N4O4 | (Ethyl-(E/Z)-3-(2-carbethoxy-2cyanoethenyl)amino-1H-pyrazole-4carboxylate); Allopurinol Related Compound F; | Allopurinol – Impurity F |
ADI-IMPM-01-00451 | 3-Amino-4-cyanopyrazole | IH | Allopurinol Nitrile Impurity; 3Aminopyrazole-4-carbonitrile; 3-Amino1H-pyrazole-4-carbonitrile | 25MG,50MG | Freezer | 16617-46-2 | 108.1 | C4H4N4 | 3-Amino-4-pyrazolecarbonitrile; NSC 44932 | Allopurinol – In house impurity |
ADI-IMPM-01-00452 | Allylamine | API | 2-Propen-1-amine; 1-Aminoprop-2-ene; 2-Propenamine; 2-Propenylamine | 25MG,50MG | NA | 107-11-9 | 57.09 | C3H7N | 3-Amino-1-propene; 3Aminopropene; 3-Aminopropylene; Monoallylamine; NSC 760 | Allylamine – API |
ADI-IMPM-01-00453 | Aloe-emodin | API | 1,8-Dihydroxy-3-(hydroxymethyl)-9,10anthracenedione; 1,8-Dihydroxy-3 (hydroxymethyl)anthraquinone | 25MG,50MG | Freezer | 481-72-1 | 270.24 | C15H10O5 | 3-Hydroxymethylchrysazin; 3Hydroxymethylchrysazine; Aloeemodol; NSC 38628; Rhabarberone; Diacerein Impurity B; | Aloe-emodin – API |
ADI-IMPM-01-00454 | Triacetyl Aloe-emodin | Imp A | 1,8-Bis(acetyloxy)-3-[(acetyloxy)methyl]9,10-anthracenedione; | 25MG,50MG | Freezer | 25395-11-3 | 396.35 | C21H16O8 | 1,8-Dihydroxy-3(hydroxymethyl)anthraquinone Triacetate; | Aloe-emodin – Impurity A |
ADI-IMPM-01-00455 | Alogliptin | API | 2-[[6-[(3R)-3-Amino-1-piperidinyl]3,4-dihydro-3-methyl-2,4-dioxo1(2H)pyrimidinyl]methyl]benzonitrile | 25MG,50MG | Refrigerat or | 850649-61-5 | 339.39 | C18H21N5O2 | NA | Alogliptin – API |
ADI-IMPM-01-00456 | Alogliptin Benzoate | API | 2-[[6-[(3R)-3-Amino-1-piperidinyl]-3,4dihydro-3-methyl-2,4-dioxo-1(2H)pyrimidinyl]methyl]benzonitrile Benzoate | 25MG,50MG | NA | 850649-62-6 | 461.51 | C25H27N504 | (R)-2-((6-(3-Aminopiperidin-1-yl)-3methyl-2,4-dioxo-3,4dihydropyrimidin-1(2H)yl)methyl)benzonitrile Benzoate; | Alogliptin Benzoate – API |
ADI-IMPM-01-00457 | (R)-N-(1-(3-(2-cyanobenzyl)-1methyl-2,6-dioxo-1,2,3,6tetrahydropyrimidin-4-yl)piperidin-3yl)-N-((2hydroxyethyl)carbamoyl)benzamid e | IH | (R)-N-(1-(3-(2-cyanobenzyl)-1methyl-2,6-dioxo-1,2,3,6tetrahydropyrimidin-4-yl)piperidin3-yl)-N-((2hydroxyethyl)carbamoyl)benzami de; | 25MG,50MG | NA | NA | 530.57 | C28H30N6O5 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00458 | 2-(2-Hydroxyethyl)isoindoline-1,3-dione | IH | N-(2-Hydroxyethyl)phthalimide; 2-(2Hydroxyethyl)-1H-isoindole-1,3(2H)dione; 2-(2-Hydroxyethyl)isoindole-1,3dione; | 25MG,50MG | NA | 3891-07-4 | 191.18 | C10H9NO3 | 2-(N-Phthalimidyl)ethyl Alcohol; 2Phthalimidoethanol; NHydroxyethylphthalimide | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00459 | (S)-2-((6-(3-(1,3-Dioxoisoindolin-2yl)piperidin-1-yl)-3-methyl-2,4dioxo-1,2,3,4-tetrahydropyrimidin5-yl)methyl)benzonitrile | IH | (S)-2-((6-(3-(1,3-Dioxoisoindolin-2yl)piperidin-1-yl)-3-methyl-2,4dioxo-1,2,3,4-tetrahydropyrimidin5-yl)methyl)benzonitrile; | 25MG,50MG | NA | NA | 469.49 | C26H23N5O4 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00460 | 2,2′-((6-Chloro-2,4-dioxopyrimidine1,3(2H,4H)diyl)bis(methylene))dibenzonitrile | IH | (R)-2-((6-(3-((3-(2-Cyanobenzyl)-1methyl-2,6-dioxo-1,2,3,6tetrahydropyrimidin-4-yl)amino)piperidin1-yl)-3-methyl-2,4-dioxo-3,4dihydropyrimidin-1(2H)yl)methyl)benzonitrile | 25MG,50MG | Freezer | 1618644-29-3 | 376.8 | C20H13ClN4O2 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00461 | (R)-2-((6-(3-((3-(2-Cyanobenzyl)-1-methyl2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4yl)amino)piperidin-1-yl)-3-methyl-2,4-dioxo3,4-dihydropyrimidin-1(2H)yl)methyl)benzonitrile | IH | (R)-2,2′-((6-(3-Aminopiperidin-1-yl)2,4-dioxopyrimidine-1,3(2H,4H)diyl)bis(methylene))dibenzonitrile | 25MG,50MG | NA | 1268836-55-0 | 578.62 | C31H30N8O4 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00462 | (R)-2,2′-((6-(3-Aminopiperidin-1-yl)2,4-dioxopyrimidine-1,3(2H,4H)diyl)bis(methylene))dibenzonitrile | IH | (R)-2,2′-((6-(3-Aminopiperidin-1yl)-2,4-dioxopyrimidine1,3(2H,4H)diyl)bis(methylene))dibenzonitrile | 25MG,50MG | NA | NA | 440.5 | C25H24N6O2 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00463 | 2-(Dibromomethyl)benzonitrile | IH | o-Cyanobenzal bromide; oCyanobezylidene Bromide | 25MG,50MG | NA | 655-63-0 | 274.94 | C8H5Br2N | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00464 | Alogliptin Benzoate S-Isomer | IH | (S)-2-((6-(3-Aminopiperidin-1-yl)3-methyl-2,4-dioxo-3,4dihydropyrimidin-1(2H)yl)methyl)benzonitrile Benzoate | 25MG,50MG | NA | NA | 461.51 | C25H27N5O4 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00465 | (R)-2-((1-(3-(2-Cyanobenzyl)-1-methyl-2,6dioxo-1,2,3,6-tetrahydropyrimidin-4yl)piperidin-3-yl)carbamoyl)benzoic Acid | IH | (R)-2-((1-(3-(2-Cyanobenzyl)-1-methyl2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4yl)piperidin-3-yl)carbamoyl)benzoic Acid | 25MG,50MG | NA | NA | 487.51 | C26H25N5O5 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00466 | (R)-2-((6-(3-Aminopiperidin-1-yl)-3-methyl2,4-dioxo-3,4-dihydropyrimidin-1(2H)yl)methyl)benzamide | IH | (R)-2-((6-(3-Aminopiperidin-1-yl)-3methyl-2,4-dioxo-3,4-dihydropyrimidin1(2H)-yl)methyl)benzamide; | 25MG,50MG | NA | NA | 357.41 | C18H23N5O3 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00467 | (R)-2-((6-(3-Aminopiperidin-1-yl)2,4-dioxo-3,4-dihydropyrimidin1(2H)-yl)methyl)benzonitrile | IH | (R)-2-((6-(3-Aminopiperidin-1-yl)2,4-dioxo-3,4-dihydropyrimidin1(2H)-yl)methyl)benzonitrile; | 25MG,50MG | NA | NA | 325.37 | C17H19N5O2 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00468 | (R)-N-(1-(3-(2-Cyanobenzyl)-1methyl-2,6-dioxo-1,2,3,6tetrahydropyrimidin-4-yl)piperidin-3yl)formamide | IH | (R)-N-(1-(3-(2-Cyanobenzyl)-1methyl-2,6-dioxo-1,2,3,6tetrahydropyrimidin-4-yl)piperidin3-yl)formamide; | 25MG,50MG | NA | NA | 367.4 | C19H21N5O3 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00469 | 2-((3-Methyl-2,4,6trioxotetrahydropyrimidin-1(2H)yl)methyl)benzonitrile | IH | Alogliptin-1-oxo-1-de(piperidin-3-amine); 2-[(tetrahydro-3-methyl-2,4,6-trioxo1(2H)-pyrimidinyl)methyl]benzonitrile; | 25MG,50MG | NA | 1246610-72-9 | 257.24 | C13H11N3O3 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00470 | 2-((6-Chloro-3-ethyl-2,4-dioxo-3,4dihydropyrimidin-1(2H)yl)methyl)benzonitrile | IH | 2-[(6-Chloro-3-ethyl-3,4-dihydro-2,4dioxo-1(2H)-pyrimidinyl)methyl]benzonitrile; | 25MG,50MG | NA | 1430222-06-2 | 289.72 | C14H12ClN3O2 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00471 | 2-((3-Aminopiperidin-1yl)methyl)benzonitrile | IH | 2-((3-Aminopiperidin-1yl)methyl)benzonitrile; | 25MG,50MG | NA | NA | 215.29 | C13H17N3 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00472 | (R)-N-(1-(3-(4-Cyanobenzyl)-1methyl-2,6-dioxo-1,2,3,6tetrahydropyrimidin-4-yl)piperidin-3yl)benzamide | IH | (R)-N-(1-(3-(4-Cyanobenzyl)-1methyl-2,6-dioxo-1,2,3,6tetrahydropyrimidin-4-yl)piperidin3-yl)benzamide | 25MG,50MG | NA | NA | 443.5 | C25H25N5O3 | NA | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00473 | Alosetron Hydrochloride | API | 2,3,4,5-Tetrahydro-5-methyl-2-[(4-methyl1H-imidazol-5-yl)methyl]-1H-pyrido[4,3b]indol-1-one Hydrochloride | 25MG,50MG | Refregerator | 122852-69-1 | 330.81 | C17H19ClN4O | GR 68755; GR 68755X; Lotronex; | Alogliptin Benzoate – In house impurity |
ADI-IMPM-01-00474 | N-Desmethyl Alosetron | IH | 2,3,4,5-Tetrahydro-2-[(5-methyl-1Himidazol-4-yl)methyl]-1H-pyrido[4,3b]indol-1-one; N-Desmethyl Lotronex | 25MG,50MG | NA | 122852-63-5 | 280.32 | C16H16N4O | 2,3,4,5-Tetrahydro-2-[(4-methyl-1Himidazol-5-yl)methyl]-1H-pyrido[4,3b]indol-1-one | Alosetron Hydrochloride – In house impurity |
ADI-IMPM-01-00475 | 6-Hydroxy Alosetron | IH | 2,3,4,5-Tetrahydro-6-hydroxy-5-methyl-2[(5-methyl-1H-imidazol-4-yl)methyl]-1Hpyrido[4,3-b]indol-1-one; | 25MG,50MG | NA | 128486-89-5 | 310.35 | C17H18N4O2 | 2,3,4,5-Tetrahydro-6-hydroxy-5methyl-2-[(4-methyl-1H-imidazol-5yl)methyl]-1H-pyrido[4,3-b]indol-1one; 6-Hydroxy Lotronex; | Alosetron Hydrochloride – In house impurity |
ADI-IMPM-01-00476 | 7-Hydroxy Alosetron | IH | 2,3,4,5-Tetrahydro-7-hydroxy-5-methyl-2[(5-methyl-1H-imidazol-4-yl)methyl]-1Hpyrido[4,3-b]indol-1-one; 7-Hydroxy Lotronex | 25MG,50MG | NA | 863485-44-3 | 310.35 | C17H18N4O2 | NA | Alosetron Hydrochloride – In house impurity |
ADI-IMPM-01-00477 | Alprazolam | API | 8-Chloro-1-methyl-6-phenyl-4H[1,2,4]triazolo[4,3-a][1,4]benzodiazepine; 8-Chloro-1-methyl-6-phenyl-4H-striazolo[4,3-a][1,4]benzodiazepine; Tensivan; Trankimazin; Tranquinal; Tricalma; U 31889; Valeans; Xanagis; Xanax; Xanax TS; Xanolam; Xanor; Zolam; Zolarem; Zoldac; Zopax; Zopic; Zotran; | 25MG,50MG | NA | 28981-97-7 | 308.76 | C17H13ClN4 | 8-Chloro-1-methyl-6-phenyl-4H2,3,5,10btetraazabenzo[e]azulene; 8-Chloro1-methyl-6-phenyl-4H-striazolo[4,3-a][1,4]benzodiazepine; Alcelam; Alpaz; Alplax; Alpralid; Alpram; Alprax; Alprazolam; Alprazolam Intensol; Alprozolam; Altraxic; Alzam; Alzolam; Anpress; Ansiopax; Apo-Alpraz; Azor; Cassadan; Constan; D 65MT; | Alprazolam – API |
ADI-IMPM-01-00478 | 5-Chloro-2-(3-methyl-4H-1,2,4-triazol-4yl)benzophenone | Imp C | [5-Chloro-2-(3-methyl-4H-1,2,4-triazol-4yl)phenyl]phenylmethanone; | 25MG,50MG | Refrigerator | 36916-19-5 | 297.74 | C16H12ClN3O | NA | Alprazolam – Impurity C |
ADI-IMPM-01-00479 | (2-Amino-5-chlorophenyl)phenylmethanone | Imp E | (2-Amino-5chlorophenyl)phenylmethanone; | 25MG,50MG | Freezer | 719-59-5 | 231.68 | C13H10ClNO | 2-Amino-5-chlorobenzylphenone; 2-Benzoyl-4-chloroaniline; 5Chloro-2-aminobenzophenone; NSC 84157; Oxazepam Benzophenone | Alprazolam – Impurity E |
ADI-IMPM-01-00480 | 7-Chloro-1-methyl-5-phenyl[1,2,4]triazolo[4,3-a]quinolin-4amine | Imp G | Triazolo[4,3-a]quinolin-4-amine, 7chloro-1-methyl-5-phenyl-[1,2,4 | 25MG,50MG | Freezer | 448950-89-8 | 308.76 | C17H13ClN4 | NA | Alprostadil – API |
ADI-IMPM-01-00481 | Alprostadil | API | 7-[(1R,2R,3R)-3-Hydroxy-2[(1E,3S)-3-hydroxyoct-1-enyl]-5oxocyclopentyl]heptanoic acid; Prostaglandin E; (11α,13E,15S)11,15-Dihydroxy-9-oxoprost-13en-1-oic Acid; 3-Hydroxy-2-(3 | 25MG,50MG | Hygroscop ic, Freezer, Under Inert Atmosphe | 745-65-3 | 354.48 | C20H34O5 | Alprox TD; Caveject; Liprostin; Palux; Prostandin; Minprog; | Alprostadil – API |
ADI-IMPM-01-00482 | Prostaglandin A1 | Imo A | 2-(3-Hydroxy-1-octenyl)-5-oxo-3cyclopentene-1-heptanoic Acid; 15-Hydroxy-9-oxoprosta-10,13dienoic Acid; 15α-Hydroxy-9ketoprosta-10,13-dienoic Acid; 15α-Hydroxy-9-oxo-10,13E | 25MG,50MG | Amber Vial, Freezer, Under inert | 14152-28-4 | 336.47 | C20H32O4 | NA | Alprostadil – Impurity A |
ADI-IMPM-01-00483 | Prostaglandin B1 | Imp B | 2-(3-Hydroxy-1-octenyl)-5-oxo-1cyclopentene-1-heptanoic Acid; 15-Hydroxy-9-oxoprosta-8(12),13dienoic Acid; 15α-Hydroxy-9ketoprosta-8(12),13-dienoic Acid; 15α-Hydroxy-9-oxo-8(12),13E | 25MG,50MG | NA | 13345-51-2 | 336.47 | C20H32O4 | NA | Alprostadil – Impurity B |
ADI-IMPM-01-00484 | 15-Keto Prostaglandin E1 | Imp C | (11α,13E)-11-Hydroxy-9,15-dioxoprost-13-en-1-oic Acid; 3-Hydroxy5-oxo-2-(3-oxo-1-octenyl)cyclopentaneheptanoic Acid; 15Keto-PGE1; | 25MG,50MG | Freezer | 22973-19-9 | 352.47 | C20H32O5 | (5Z)-7-[(1R,2R,3R)-3Hydroxy-2-[(1E,3S)-3hydroxyoct-1-enyl]-5- oxocyclopentyl]hept-5-enoic Acid; | Alprostadil – Impurity C |
ADI-IMPM-01-00485 | 15-epiprostaglandin E1 | Imp D | 7-[(1R,2R,3R)-3-hydroxy-2[(1E,3R)-3-Hydroxyoct-1-enyl]-5- oxocyclopentyl]heptanoic Acid; 7((1R,2R,3R)-3-Hydroxy-2-((R,E)-3hydroxyoct-1-en-1-yl)-5 | 25MG,50MG | NA | NA | 354.48 | C20H34O5 | NA | Alprostadil – Impurity D |
ADI-IMPM-01-00486 | 11-epiprostaglandin E1 | Imp E | 7-[(1R,2R,3S)-3-hydroxy-2[(1E,3S)-3-Hydroxyoct-1-enyl]-5- oxocyclopentyl]heptanoic Acid; 7((1R,2R,3S)-3-Hydroxy-2-((S,E)-3hydroxyoct-1-en-1-yl)-5oxocyclopentyl | 25MG,50MG | NA | NA | 354.48 | C20H34O6 | NA | Alprostadil – Impurity E |
ADI-IMPM-01-00487 | 8-epiprostaglandin E1 | Imp F | 7-[(1S,2R,3R)-3-hydroxy-2[(1E,3S)-3-Hydroxyoct-1-enyl]-5- oxocyclopentyl]heptanoic Acid; 7((1S,2R,3R)-3-Hydroxy-2-((S,E)-3hydroxyoct-1-en-1-yl)-5 | 25MG,50MG | NA | NA | 354.48 | C20H34O7 | NA | Alprostadil – Impurity F |
ADI-IMPM-01-00488 | Dinoprostone | Imp G | Prostaglandin E2; (5Z,11α,13E,15S)-11,15Dihydroxy-9-oxoprosta-5,13-dien1-oic Acid; 7-[3-Hydroxy-2-(3hydroxy-1-octenyl)-5oxocyclopentyl]-5-heptenoic Acid | 25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphe | 363-24-6 | 352.47 | C20H32O5 | NA | Alprostadil – Impurity G |
ADI-IMPM-01-00489 | (5E)-prostaglandin E2 | Imp H | (5E)-7-[(1R,2R,3R)-3-Hydroxy-2[(1E,3S)-3-hydroxyoct-1-enyl]-5- oxocyclopentyl]hept-5-enoic Acid; (E)-7-((1R,2R,3R)-3-Hydroxy-2((S,E)-3-hydroxyoct-1-en-1-yl)-5 | 25MG,50MG | NA | NA | 352.47 | C20H32O6 | NA | Alprostadil – Impurity H |
ADI-IMPM-01-00490 | Prostaglandin E1, Ethyl Ester | Imp I | Ethyl 7-[(1R,2R,3R)-3-hydroxy-2[(1E,3S)-3-hydroxyoct-1-enyl]-5- oxocyclopentyl]heptanoate; Ethyl 7-((1R,2R,3R)-3-hydroxy-2-((S,E)3-hydroxyoct-1-en-1-yl)-5 | 25MG,50MG | NA | NA | 382.53 | C22H38O5 | NA | Alprostadil – Impurity I |
ADI-IMPM-01-00491 | Prostaglandin E1, Isopropyl Ester | Imp J | 1-Methylethyl 7-[(1R,2R,3R)-3hydroxy-2-[(1E,3S)-3-hydroxyoct- 1-enyl]-5oxocyclopentyl]heptanoate; Isopropyl 7-((1R,2R,3R)-3hydroxy-2-((S,E)-3-hydroxyoct | 25MG,50MG | NA | NA | 396.56 | C23H40O5 | NA | Alprostadil – Impurity J |
ADI-IMPM-01-00492 | Triphenylphosphine Oxide | imp K | Triphenyl Phosphorus Oxide; Triphenylphosphine Monoxide; Orlistat Related Compound C | 25MG,50MG | NA | 791-28-6 | 278.28 | C18H15OP | NA | Alprostadil – Impurity K |
ADI-IMPM-01-00493 | Aluminum Hydroxide | API | Aluminum Hydroxide; 40CD; 42STE; A 02; A 3011; AC 400; AC 400 (hydroxide); AC 450; AC 470; AC 714KC; AE 107; AF 260; AKP-DA; ALH; ALH 3L; ALH-F; AS 5; AS 5 (hydroxide); ATH 100; Amphojel; Antipollon HT; Apyral; | 25MG,50MG | NA | 21645-51-2 | 78 | AlH3O3 | Alcan SF 4; Alcoa 331; Alumina Hydrate; Alumina Trihydrate; Aluminic Acid (H3AlO3); Aluminum Hydroxide Gel; Aluminum Oxide (Al2O3), Trihydrate; Aluminum Oxide Hydrate; Aluminum Oxide Trihydrate; Aluminum | Aluminum Hydroxide – API |
ADI-IMPM-01-00494 | Alverine Citrate | API | N-Ethyl-N-(3phenylpropyl)benzenepropanamine 2Hydroxy-1,2,3- propanetricarboxylate | 25MG,50MG | Refrigerator | 5560-59-8 | 473.56 | C26H35NO7 | N-Ethyl-3,3’diphenyldipropylamine Citrate; Antispasmin; Calmabel; Gamatran; NSC 35459; Profenine; Prophelan; Proverine; Spacolin; | Alverine Citrate – API |
ADI-IMPM-01-00495 | 1-Chloro-3-phenylpropane | Imp A | 1-Chloro-3-phenylpropane | 25MG,50MG | NA | 104-52-9 | 154.64 | C9H11Cl | NA | Alverine Citrate – Impurity A |
ADI-IMPM-01-00496 | 3-Phenylpropan-1-ol | Imp B | 3-Phenylpropan-1-ol; | 25MG,50MG | NA | 122-97-4 | 136.19 | C9H12O | NA | Alverine Citrate – Impurity B |
ADI-IMPM-01-00497 | N-Ethyl-3-phenylpropan-1-amine Hydrochloride | Imp C | N-Ethyl-3-phenylpropan-1-amine Hydrochloride; | 25MG,50MG | NA | 13125-63-8 | 199.72 | C11H17N.Cl H | NA | Alverine Citrate – Impurity C |
ADI-IMPM-01-00498 | (3-Cyclohexyl-propyl)-ethyl-(3-phenylpropyl)-amine Hydrochloride | Imp D | N-(3-Cyclohexylpropyl)-N-ethyl-3phenylpropan-1-amine Hydrochloride; 3Cyclohexyl-N-ethyl-N-(3phenylpropyl)propan-1-amine Hydrochloride; | 25MG,50MG | NA | NA | 323.94 | C20H34ClN | NA | Alverine Citrate – Impurity D |
ADI-IMPM-01-00499 | Tris-(3-phenyl-propyl)-amine Hydrochloride | Imp E | 3-Phenyl-N,N-bis(3-phenylpropyl)propan1-amine Hydrochloride; | 25MG,50MG | NA | 878784-75-9 | 408.02 | C27H33N.ClH | ANA | Alverine Citrate – Impurity E |
ADI-IMPM-01-00500 | Alvimopan | API | N-[(2S)-2-[[(3R,4R)-4-(3-Hydroxyphenyl)3,4-dimethyl-1-piperidinyl]methyl]-1-oxo3-phenylpropyl]glycine; | 25MG,50MG | Refrigerator | 156053-89-3 | 424.53 | C25H32N2O4 | ADL 8-2698; LY 246736; Entereg | Alverine Citrate – Impurity F |
ADI-IMPM-01-00501 | (R)-Ethyl-2-(2((methylsulfonyloxy)methyl)-3phenylpropanamido)acetate | IH | (R)-Ethyl 2-(2-benzyl-3((methylsulfonyl)oxy)propanamid o)acetate; | 25MG,50MG | NA | 343.4 | C15H21NOBS | NA | Alvimopan – In house impurity | |
ADI-IMPM-01-00502 | Ethyl 2-(2-benzyl-3hydroxypropanamido)acetate | IH | (S)-Ethyl 2-(2-benzyl-3hydroxypropanamido)acetate; Ethyl 2-[(2S)-2-benzyl-3-hydroxy propanamido]acetate | 25MG,50MG | NA | NA | 265.3 | C14H19N04 | NA | Alvimopan – In house impurity |
ADI-IMPM-01-00503 | Ethyl 2-(2-benzylprop-2-enamido)acetate | IH | N-[1-Oxo-2-(phenylmethyl)-2propenyl]glycine Ethyl Ester; [(2Methylene-1-oxo-3phenylpropyl)amino]acetic Acid Ethyl Ester; | 25MG,50MG | NA | 660848-81-7 | 247.29 | C14H17N03 | NA | Alvimopan – In house impurity |
ADI-IMPM-01-00504 | 2-[(2S)-2-Benzyl-3(methanesulfonyloxy) propanamido]acetic Acid | IH | (S)-2-(2-Benzyl-3((methylsulfonyl)oxy)propanamid o)acetic Acid; | 25MG,50MG | NA | NA | 315.34 | C13H17NO6S | NA | Alvimopan – In house impurity |
ADI-IMPM-01-00505 | Ethyl 2-((S)-2-benzyl-3-(benzyloxy) propanamido)acetate | IH | (S)-Ethyl 2-(2-benzyl-3(benzyloxy)propanamido)acetate | 25MG,50MG | NA | NA | 355.43 | C21H25NO4 | NA | Alvimopan – In house impurity |
ADI-IMPM-01-00506 | 3-((3S,4S)-3,4-Dimethylpiperidin-4yl)phenol | IH | 3-((3R,4S)-3,4-Dimethylpiperidin4-yl)phenol | 25MG,50MG | NA | NA | 205.3 | C13H19NO | NA | Alvimopan – In house impurity |
ADI-IMPM-01-00507 | 3-((3S,4S)-3,4-Dimethylpiperidin-4yl)phenol | IH | 3-((3S,4R)-3,4-Dimethylpiperidin4-yl)phenol | 25MG,50MG | NA | NA | 205.3 | C13H19NO | NA | Alvimopan – In house impurity |
ADI-IMPM-01-00508 | 3-((3S,4S)-3,4-Dimethylpiperidin-4yl)phenol | IH | 3-((3S,4R)-3,4-Dimethylpiperidin4-yl)phenol | 25MG,50MG | NA | NA | 205.3 | C13H19NO | NA | Alvimopan – In house impurity |
ADI-IMPM-01-00509 | (R)-1,2,3,6-Tetrahydro-4-(3isopropoxyphenyl)-1,3dimethylpyridine | IH | (R)-4-(3-Isopropoxyphenyl)-1,3dimethyl-1,2,3,6tetrahydropyridine; | 25MG,50MG | NA | NA | 245.36 | C16H23NO | NA | Alvimopan – In house impurity |
ADI-IMPM-01-00510 | (3R,4S)-1,2,3,4-Tetrahydro-4-(3isopropoxyphenyl)-1,3,4trimethylpyridine | IH | (3R,4S)-4-(3-Isopropoxyphenyl)1,3,4-trimethyl-1,2,3,4tetrahydropyridine; | 25MG,50MG | NA | NA | 259.39 | C17H25NO | NA | Alvimopan – In house impurity |
ADI-IMPM-01-00511 | (3R,4R)-Phenyl 4-(3isopropoxyphenyl)-3,4dimethylpiperidine-1-carboxylate | IH | (3R,4R)-Phenyl 4-(3isopropoxyphenyl)-3,4dimethylpiperidine-1-carboxylate | 25MG,50MG | NA | NA | 367.48 | C23H29NO3 | NA | Alvimopan – In house impurity |
ADI-IMPM-01-00512 | Amantadine Hydrochloride | API | Tricyclo[3.3.1.13,7]decan-1-amine Hydrochloride | 25MG,50MG | NA | 665-66-7 | 187.71 | C10H18ClN | EXP-105-1; NSC-83653; Adekin; Lysovir; Mantadan; Mantadine; Mantadix; Symmetrel; Virofral; | Amantadine Hydrochloride – API |
ADI-IMPM-01-00513 | Ambrisentan | API | (αS)-α-[(4,6-Dimethyl-2pyrimidinyl)oxy]-β-methoxy-βphenylbenzenepropanoic Acid; | 25MG,50MG | NA | 177036-94-1 | 378.42 | C22H22N2O4 | NA | Ambrisentan – API |
ADI-IMPM-01-00514 | 4,6-Dimethyl-2(methylsulfonyl)pyrimidine | IH | 2-(Methylsulfonyl)-4,6dimethylpyrimidine; 2Methanesulfonyl-4,6dimethylpyrimidine; Ambrisentan Sulfonyl Pyrimidine Impurity; | 25MG,50MG | Refrigerator | 35144-22-0 | 186.23 | C7H10N2O2S | NA | Ambrisentan – In house impurity |
ADI-IMPM-01-00515 | Ambrisentan Hydroxy Acid Impurity | IH | (S)-2-Hydroxy-3-methoxy-3,3diphenylpropionic Acid; (S)-2Hydroxy-3-methoxy-3,3diphenylpropionic Acid; 2S-2Hydroxy-3-methoxy-3,3 | 25MG,50MG | NA | 178306-52-0 | 272.3 | C16H16O4 | (S)-α-Hydroxy-β-methoxy-βphenyl-benzenepropanoic Acid; | Ambrisentan – In house impurity |
ADI-IMPM-01-00516 | (S)-Methyl 2-hydroxy-3-methoxy3,3-diphenylpropanoate | IH | 3-Diphenylpropanoate, (S)-methyl 2-hydroxy-3-methoxy-3; Ambrisentan Hydroxyester Impurity; | 25MG,50MG | NA | 177036-78-1 | 286.32 | C17H18O4 | NA | Ambrisentan – In house impurity |
ADI-IMPM-01-00517 | Ambrisentan Pyrimidine Ester Impurity | IH | (S)-Methyl 2-((4,6dimethylpyrimidin-2-yl)oxy)-3methoxy-3,3-diphenylpropanoate | 25MG,50MG | NA | NA | 392.45 | C23H24N2O4 | NA | Ambrisentan – In house impurity |
ADI-IMPM-01-00518 | Ambrisentan Vinyloxy Impurity | IH | 2-((2,2-Diphenylvinyl)oxy)-4,6dimethylpyrimidine; | 25MG,50MG | NA | 1639429-81-4 | 302.37 | C20H18N2O | NA | Ambrisentan – In house impurity |
ADI-IMPM-01-00519 | (R)-Ambrisentan | IH | (R)-2-((4,6-Dimethylpyrimidin-2yl)oxy)-3-methoxy-3,3diphenylpropanoic Acid; Ambrisentan R-isomer; | 25MG,50MG | NA | 1007358-76-0 | 378.16 | C22H22N2O4 | NA | Ambrisentan – In house impurity |
ADI-IMPM-01-00520 | Ambroxol | API | trans-4-[(2-Amino-3,5dibromobenzyl)amino]cyclohexanol; trans-4-[[(2-Amino3,5dibromophenyl)methyl]amino]cycl ohexanol; | 25MG,50MG | NA | 18683-91-5 | 378.1 | C13H18Br2N2O | 2-Amino-3,5-dibromo-N(trans-4hydroxycyclohexyl)benzylam ine; N-(trans-4Hydroxycyclohexyl)-2-amino3,5-dibromobenzylamine | Ambroxol – API |
ADI-IMPM-01-00521 | Ambroxol Hydrochloride | API | 4-[[(2-Amino-3,5dibromophenyl)methyl]amino]cycophexa nol Hydrochloride; | 25MG,50MG | Freezer | 23828-92-4 | 414.56 | C13H19Br2ClN2O | Abramen; Ambril; Bronchopront; Duramucal; Bluibron; Fluixol; Frenopect | Ambroxol Hydrochloride – API |
ADI-IMPM-01-00522 | (2-Amino-3,5-dibromophenyl)methanol | Imp A | 2-Amino-3,5-dibromobenzyl Alcohol; | 25MG,50MG | Refrigerator | 50739-76-9 | 280.94 | C7H7Br2NO | NA | Ambroxol Hydrochloride – Impurity A |
ADI-IMPM-01-00523 | trans-4-(6,8-Dibromo-1,4dihydroquinazolin-3(2H)-yl)cyclohexanol Hydrochloride | Imp B | trans-4-(6,8-Dibromo-1,4dihydroquinazolin-3(2H)-yl)cyclohexanol Hydrochloride; | 25MG,50MG | NA | 15942-08-2 | 426.57 | C14H19Br2ClN2O | NA | Ambroxol Hydrochloride – Impurity B |
ADI-IMPM-01-00524 | trans-4-[[(E)-2-Amino-3,5dibromobenzyliden]amino]cyclohexanol | Imp C | trans-Ambroxol | 25MG,50MG | NA | 50910-53-7 | 376.09 | C13H16Br2N2O | NA | Ambroxol Hydrochloride – Impurity C |
ADI-IMPM-01-00525 | rac-cis-Ambroxol | Imp D | cis-4-[[(2-Amino-3,5dibromophenyl)methyl]amino]cyclohexan ol; | 25MG,50MG | NA | 107814-37-9 | 378.1 | C13H18Br2N2O | NA | Ambroxol Hydrochloride – Impurity D |
ADI-IMPM-01-00526 | 2-Amino-3,5-dibromobenzaldehyde | Imp E | 2-Amino-3,5-dibromobenzaldehyde; 3,5Dibromo-2-aminobenzaldehyde | 25MG,50MG | Freezer | 50910-55-9 | 278.93 | C7H5Br2NO | NA | Ambroxol Hydrochloride – Impurity E |
ADI-IMPM-01-00527 | trans-4-Aminocyclohexanol Hydrochloride | IH | trans-1-Amino-4-hydroxycyclohexane Hydrochloride | 25MG,50MG | NA | 50910-54-8 | 151.63 | C6H14ClNO | trans-4-Amino-1-cyclohexanol Hydrochloride; trans-4Aminocyclohexanol Monohydrochloride; trans-4Hydroxycyclohexylamine | Ambroxol Hydrochloride – In house impurity |
ADI-IMPM-01-00528 | cis-4-Aminocyclohexanol Hydrochloride | IH | cis-4-Hydroxycyclohexylamine Hydrochloride; | 25MG,50MG | NA | 56239-26-0 | 151.63 | C6H14ClNO | NA | Ambroxol Hydrochloride – In house impurity |
ADI-IMPM-01-00529 | Ambroxol Monobromo Impurity | IH | Ambroxol Monobromine; trans-4-[[(2Amino-5-bromophenyl)methyl]amino]cyclohexanol | 25MG,50MG | Refrigerator | 101900-43-0 | 299.21 | C13H19BrN2O | NA | Ambroxol Hydrochloride – In house impurity |
ADI-IMPM-01-00530 | 4-(6,8-Dibromo-3(4H)-quinazolinyl)cyclohexanol | IH | 4-(6,8-Dibromoquinazolin-3(4H)yl)cyclohexanol; Ambroxol Cycloimine Impurity | 25MG,50MG | NA | 388.1 | C14H16Br2N2O | NA | Ambroxol Hydrochloride – In house impurity | |
ADI-IMPM-01-00531 | Amidotrizoic Acid Dihydrate | API | Diatrizoic Acid Dihydrate; 3,5Bis(acetylamino)-2,4,6triiodobenzoic Acid Dihydrate; | 25MG,50MG | Amber Vial, Freezer | 50978-11-5 | 649.94 | C11H13I3N2O6 | NA | Amidotrizoic Acid Dihydrate – API |
ADI-IMPM-01-00532 | 3,5-bis(Acetylamino)-2,4diiodobenzoic Acid | Imp B | 3,5-Diacetamido-2,4diiodobenzoic Acid; | 25MG,50MG | NA | 488.02 | C11H10I2N2O4 | NA | Amidotrizoic Acid Dihydrate – Impurity B | |
ADI-IMPM-01-00533 | 3,5-bis(Acetylamino)-2,6diiodobenzoic Acid | Imp C | 3,5-Diacetamido-2,6diiodobenzoic Acid; | 25MG,50MG | NA | 162193-53-5 | 488.02 | C11H10I2N2O4 | NA | Amidotrizoic Acid Dihydrate – Impurity C |
ADI-IMPM-01-00534 | 3-(Acetylamino)-5[(iodoacetyl)amino]-2,4,6triiodobenzoic Acid | Imp D | 3-Acetamido-2,4,6-triiodo-5-(2iodoacetamido)benzoic Acid | 25MG,50MG | NA | 739.81 | C11H8I4N2O4 | NA | Amidotrizoic Acid Dihydrate – Impurity D | |
ADI-IMPM-01-00535 | Amikacin | API | 6-O-(3-Amino-3-deoxy-α-Dglucopyranosyl)-4-O-(6-amino-6-deoxy-αD- glucopyranosyl)-1-N-[(2S)-4-amino-2hydroxybutanoyl]-2-deoxy-Dstreptamine; Amikacillin; Amikacin; Amikozit; Amukin; Antibiotic BB-K 8; Arikace; Lukadin; Potentox; | 25MG,50MG | Hygroscopic, Refrigerator, under inert atmosphere | 37517-28-5 | 585.6 | C22H43N5O13 | (S)-O-3-Amino-3-deoxy-α-Dglucopyranosyl-(1→6)-O-[6-amino6-deoxy-α-D-glucopyranosyl(1→4)]-N1-(4-amino-2-hydroxy-1oxobutyl)-2-deoxy-D-streptamine; 1-N-[L-(-)-γ-Amino-αhydroxybutyryl]kanamycin A; Amicacin; BAY 41-6551; BAY 416651; BB-K 8; | Amikacin – AP |
ADI-IMPM-01-00536 | Amikacin Sulfate | API | Amikacin Disulfate Salt; 1-N-[L-(-)-γAmino-α-hydroxybutyryl]kanamycin A Sulfate; 6-O-(3-Amino-3-deoxy-α-Dglucopyranosyl)-4-O-(6-amino-6-deoxy-αD- glucopyranosyl)-1-N-[(2S)-4-amino-2hydroxybutanoyl]-2-deoxy-D-streptamine Sulfate; Mikavir; Novamin; Pierami; Selemycin | 25MG,50MG | Hygroscopic, Refrigerator, under inert atmosphere | 39831-55-5 | 781.76 | C22H47N5O21S2 | O-3-Amino-3-deoxy-α-Dglucopyranosyl-(1→6)-O-[6-amino6-deoxy-α-D-glucopyranosyl(1→4)]-N1-[(2S)-4-amino-2hydroxy-1-oxobutyl]-2-deoxy-Dstreptamine Sulfate; Amiglyde V; Amika; Amikacin Disulfate; Amikacin Sulfate; Amikavet; Amikin; Amiklin; Antibiotic BB-K | Amikacin Sulfate – API |
ADI-IMPM-01-00537 | Amiloride Hydrochloride | API | N-Amidino-3,5-diamino-6chloropyrazinecarboxamide Hydrochloride Dihydrate; Amiloride Hydrochloride Dihydrate | 25MG,50MG | NA | 17440-83-4 | 302.12 | C6H13Cl2N7O3 | NA | Amiloride Hydrochloride – API |
ADI-IMPM-01-00538 | Methyl 3,5-diamino-6-chloropyrazine-2carboxylate | Imp A | 3,5-Diamino-6-chloropyrazine-2carboxylic Acid Methyl Ester; Methyl 3,5Diamino-6-chloropyrazinecarboxylate; | 25MG,50MG | Refrigerator | 1458-01-1 | 202.6 | C6H7ClN4O2 | 3,5-Diamino-6-chloro-2pyrazinecarboxylic Acid Methyl Ester; Amiloride Related Compound A; | Amiloride Hydrochloride – Impurity A |
ADI-IMPM-01-00539 | Amiodarone Hydrochloride | API | (2-Butyl-3-benzofuranyl)[4-[2(diethylamino)ethoxy]-3,5diiodophenyl]methanone Hydrochloride; | 25MG,50MG | Freezer | 19774-82-4 | 681.77 | C25H30ClI2NO3 | 4-[2-(Diethylamino)ethoxy]-3,5diiodophenyl 2-butyl-3benzofuranyl Ketone Hydrochloride; Amiodar; Amiodaronum Hydrochloride; Ancoron; Angiodarona; Atlansil; Cordarex; Cordarone; Cordarone X; L 3428; L 3428-Labaz; Miocard; | Amiodarone Hydrochloride – API |
ADI-IMPM-01-00540 | Di-Desiodo Amiodarone Hydrochloride | Imp A | (2-Butylbenzofuran-3-yl)[4-[2(diethylamino) ethoxy]phenyl]methanone Hydrochloride; | 25MG,50MG | NA | 95820-13-6 | 429.21 | C25H32ClNO3 | Amiodarone Related Compound A | Amiodarone Hydrochloride – Impurity A |
ADI-IMPM-01-00541 | Desethyl Amiodarone Hydrochloride | Imp B | 2-Butyl-3-benzofuranyl-4-[2(ethylamino)ethoxy]-3,5-diiodophenyl Ketone Hydrochloride; | 25MG,50MG | Freezer, Under Inert Atmosphere | 96027-74-6 | 653.72 | C23H26ClI2NO3 | Desethylamiodarone Hydrochloride; | Amiodarone Hydrochloride – Impurity B |
ADI-IMPM-01-00542 | Deiodo Amiodarone | Imp C | Monodesiodo Amiodarone; (2-Butyl-3benzofuranyl)[4-[2-(diethylamino)ethoxy]3-iodophenyl]methanone; L 6355 | 25MG,50MG | NA | 85642-08-6 | 519.42 | C25H30INO3 | NA | Amiodarone Hydrochloride – Impurity C |
ADI-IMPM-01-00543 | 2-Butyl-3-(3,5-diiodo-4hydroxybenzoyl)benzofuran | Imp D | (2-Butyl-benzofuran-3-yl)-(4-hydroxy-3,5diiodo-phenyl)-methanone; | 25MG,50MG | Refrigerator | 1951-26-4 | 546.14 | C19H16I2O3 | Amiodarone Related Compound D; | Amiodarone Hydrochloride – Impurity D |
ADI-IMPM-01-00544 | 2-Butyl-3-(4-hydroxybenzoyl)benzofuran | Imp E | (2-Butyl-benzofuran-3-yl)-(4-hydroxyphenyl)-methanone; (2-Butylbenzofuran3-yl)-(4-hydroxyphenyl)ketone | 25MG,50MG | Refrigerator | 52490-15-0 | 294.34 | C19H18O3 | Amiodarone Related Compound E; | Amiodarone Hydrochloride – Impurity E |
ADI-IMPM-01-00545 | De(diethylaminoethyl-5-iodo) Amiodarone | Imp F | (2-Butyl-3-benzofuranyl)(4-hydroxy-3iodophenyl)methanone; L 6424 | 25MG,50MG | Refrigerator | 147030-50-0 | 420.24 | C19H17IO3 | NA | Amiodarone Hydrochloride – Impurity F |
ADI-IMPM-01-00546 | Methoxy Amiodarone | Imp G | 1-Methoxy Amiodarone; [2-[(1RS)-1Methoxybutyl]benzofuran-3-yl][4-[2(diethylamino)ethoxy]-3,5-diiodophenyl] methanone; | 25MG,50MG | Amber Vial, Refrigerator | 1087223-70-8 | 675.34 | C26H31I2NO4 | [2-[(1RS)-1Methoxybutyl]benzofuran-3-yl][4-[2(diethylamino)ethoxy] -3,5diiodophenyl]methanone; [4-[2(Diethylamino)ethoxy]-3,5diiodophenyl][2-(1-methoxybutyl)-3benzofuranyl]methanone; | Amiodarone Hydrochloride – Impurity G |
ADI-IMPM-01-00547 | 2-Chloro-N,N-diethylethanamine Hydrochloride | Imp H | (2-Chloroethyl)diethylamine Hydrochloride; 1-Chloro-2(diethylamino)ethane Hydrochloride; 1Diethylamino-2-chloroethane Hydrochloride; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 869-24-9 | 172.1 | C6H15Cl2N | 2-(Diethylamino)-1-chloroethane Hydrochloride; Diethyl(2chloroethyl)amine Hydrochloride; Diethylaminoethyl Chloride; Amiodarone Related Compound | Amiodarone Hydrochloride – Impurity H |
ADI-IMPM-01-00548 | N,N-Di-Desethyl Amiodarone IH | IH | Di(N-desethyl) Amiodarone Hydrochloride; Metabolite; | 25MG,50MG | Refrigerator | 757220-04-5 | C21H22ClI2NO3 | [4-(2-Aminoethoxy)-3,5diiodophenyl](2-butyl-3benzofuranyl)methanone Hydrochloride; L 33530; LB 32922; (2-Butylbenzofuran-3-yl)[4-[2aminoethoxy]-3,5diiodophenyl]methanone | Amiodarone Hydrochloride – In house impurity | |
ADI-IMPM-01-00549 | Amiodarone N-Oxide Hydrochloride | IH | 2-(4-(2-Butylbenzofuran-3carbonyl)-2,6-diiodophenoxy)-N,Ndiethylethanamine oxide Hydrochloride | 25MG,50MG | NA | 318267-30-0 | 625.67 | C25H30ClI2NO4 | NA | Amiodarone Hydrochloride – In house impurity |
ADI-IMPM-01-00550 | 3-Bromo-2-(1methoxybutyl)benzofuran | IH | 3-Bromo-2-(1methoxybutyl)benzofuran | 25MG,50MG | NA | 1391053-512 | 697.77 | C13H15BrO2 | NA | Amiodarone Hydrochloride – In house impurity |
ADI-IMPM-01-00551 | Amisulpride | API | 4-Amino-N-[(1-ethyl-2pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2methoxybenzamide; Aminosultopride; DAN-2163; Socian; Solian; Sulamid | 25MG,50MG | freezer | 71675-85-9 | 283.16 | C17H27N3O4S | NA | Amisulpride – API |
ADI-IMPM-01-00552 | 2-(Aminomethyl)-1-ethylpyrrolidine | Imp A | [(2RS)-1-Ethylpyrrolidin-2yl]methanamine; Sulpiride Imp A; | 25MG,50MG | NA | 26116-12-1 | 369.48 | C7H16N2 | NA | Amisulpride – Impurity A |
ADI-IMPM-01-00553 | 4-Amino-N-[[(2RS)-1-ethylpyrrolidin-2yl]methyl]-5-(ethylsulphonyl)-2hydroxybenzamide | Imp B | 4-Amino-N-[[(2RS)-1-ethylpyrrolidin-2yl]methyl]-5-(ethylsulfonyl)-2Hydroxybenzamide; | 25MG,50MG | Refrigerator | 148516-54-5 | 128.22 | C16H25N3O4S | 4-amino-N-[[(2RS)-1ethylpyrrolidin-2-yl]methyl]-5(ethylsulphonyl)-2hydroxybenzamide | Amisulpride – Impurity B |
ADI-IMPM-01-00554 | 4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]2-methoxy-5-(methylsulfonyl)-benzamide | Imp D | 4-Amino-N-[[(2RS)-1-ethylpyrrolidin-2yl]methyl]-2-methoxy-5(methylsulphonyl)benzamide; | 25MG,50MG | NA | 71676-00-1 | 355.45 | C16H25N3O4S | NA | Amisulpride – Impurity C |
ADI-IMPM-01-00555 | 4-Amino-5-(ethylsulfonyl)-2methoxybenzoic Acid | Imp E | 2-Methoxy-4-amino-5ethylsulfonylbenzoic Acid; | 25MG,50MG | Freezer | 71675-87-1 | 355.45 | C10H13NO5S | NA | Amisulpride – Impurity D |
ADI-IMPM-01-00556 | 4-Amino-N-(1-ethyl-3-piperidinyl)-5(ethylsulfonyl)-2-methoxybenzamide | IH | 2-Methoxy-4-amino-5ethylsulfonylbenzoic Acid; | 25MG,50MG | NA | 148516-68-1 | 259.28 | C17H27N3O4S | NA | Amisulpride – Impurity E |
ADI-IMPM-01-00557 | Amisulpride N-Oxide | IH | N-Des[(1-ethyl-2-pyrrolidinyl)methyl]-N(1-ethyl-3-piperidinyl) Amisulpride | 25MG,50MG | Freezer | 71676-01-2 | 369.48 | C17H27N3O4S | 4-Amino-N-[(1-ethyl-2pyrrolidinyl)methyl]-5(ethylsulfonyl)- 2methoxybenzamide N-Oxide; | Amisulpride – In house impurity |
ADI-IMPM-01-00558 | 1-Ethyl-2-[(methylamino)methyl]pyrrolidine Hydrochloride | IH | 1-(1-Ethylpyrrolidin-2-yl)-Nmethylmethanamine Hydrochloride; 1Ethyl-N-methyl-2pyrrolidinemethanamine Hydrochloride | 25MG,50MG | NA | NA | 178.7 | C8H19ClN2 | NA | Amisulpride – In house impurity |
ADI-IMPM-01-00559 | 5′-Oxo Amisulpride | IH | 4-Amino-N-[(1-ethyl-5-oxo-2pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2methoxybenzamide; | 25MG,50MG | NA | 1391052-47-3 | 383.46 | C17H25N3O5S | NA | Amisulpride – In house impurity |
ADI-IMPM-01-00560 | Methyl 4-Amino-2-methoxy-5thiocyanatobenzoate | IH | 4-Amino-5-(cyanosulfanyl)-2methoxybenzoic Acid Methyl Ester; Methyl 4-Amino-2-methoxy5-thiocyanobenzoate; | 25MG,50MG | NA | 59168-56-8 | 238.26 | C8H9NO3S | NA | Amisulpride – In house impurity |
ADI-IMPM-01-00561 | 2-Methoxy-4-amino-5ethylthiobenzoic Acid | IH | 4-Amino-5-(ethylthio)-2-methoxybenzoic Acid | 25MG,50MG | NA | 71675-86-0 | 227.28 | C10H13NO3S | NA | Amisulpride – In house impurity |
ADI-IMPM-01-00562 | Amitraz | API | N’-(2,4-Dimethylphenyl)-N-[[(2,4dimethylphenyl)imino]methyl]-N-methylmethanimidamide; | 25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphere | 33089-61-1 | 293.41 | C19H23N3 | N-Methyl-N’-2,4-xylyl-N-(N-2,4xylylformimidoyl)formamidine; Acarac; Amigard; Apivar ND; Azaform; BAAM; Ovasyn; Parsec; TCL; Taktic; Triazid; U 36059; Varamit | Amitraz – API |
ADI-IMPM-01-00563 | 2,4-Dimethylaniline | Imp A | 2,4-Dimethylaniline; 1-Amino-2,4dimethylbenzene; 2,4-Dimethylaniline; 2,4-Dimethylbenzenamine; 2,4-Xylidine | 25MG,50MG | NA | 95-68-1 | 121.18 | C8H11N | 2,4-Dimethylphenylamine; 2,4Xylylamine; 4-Amino-1,3dimethylbenzene; 4-Amino-1,3xylene; NSC 7640; m-Xylidine | Amitraz – Impurity A |
ADI-IMPM-01-00564 | N,N’-Bis(2,4-xylyl)formamidine | IH | N,N’-Bis(2,4dimethylphenyl)methanimidamide; N,N’Di-2,4-xylylformamidine; N,N’-Bis(2,4dimethylphenyl)formamidine | 25MG,50MG | Freezer | \16596-04-6 | 252.35 | C17H20N2 | NA | Amitraz – In house impurity |
ADI-IMPM-01-00565 | N,N’-Bis(2,4-xylyl)-N-methylformamidine Hydrochloride | IH | N,N’-Bis(2,4-dimethylphenyl)-Nmethylmethanimidamide Hydrochloride; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 1391062-43-3 | 302.84 | C18H23ClN2 | NA | Amitraz – In house impurity |
ADI-IMPM-01-00566 | N-(2,4-Dimethylphenyl)formamide | IH | 2,4-Dimethylformanilide; 2,4Dimethylphenylformamide; BTS 27919; NSC 406488 | 25MG,50MG | Refregerator | 60397-77-5 | 149.19 | C9H11NO | NA | Amitraz – In house impurity |
ADI-IMPM-01-00567 | N’-(2,4-Dimethylphenyl)-Nmethylformamide Hydrochloride | IH | N-(2,4-Dimethylphenyl)-N’methylmethanimidamide Hydrochloride; | 25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphere | 60397-77-5 | 198.69 | C10H15ClN2 | N-(2,4-Dimethylphenyl)-N’-methyl methylamidine Hydrochloride; Danjiami; N-(2,4-Dimethylphenyl)N’-methylmethanimidamide Hydrochloride; N-Methyl-N’-(2,4xylyl)formamidine Hydrochloride; N’-(2,4-Xylyl)-NMethylformamidine Hydrochloride; Semiamitraz Chloride; U 40481A | Amitraz – In house impurity |
ADI-IMPM-01-00568 | Amitriptyline | API | 3-(10,11-dihydro-5Hdibenzo[a,d]cycloheptene-5-ylidene)-N,Ndimethylpropan-1-amine; | 25MG,50MG | NA | 50-48-6 | 277.4 | C20H23N | NA | Amitriptyline – API |
ADI-IMPM-01-00569 | Amitriptyline Hydrochloride | API | 3-(10,11-Dihydro-5Hdibenzo[a,d]cyclohepten-5-ylidene)-N,Ndimethyl-1-propanamine Hydrochloride; | 25MG,50MG | Refrigerator | 549-18-8 | 313.86 | C20H24ClN | Adepril; Amineurin; Domical; Elavil; Endep; Euplit; Laroxyl; Tryptanol; Tryptizol; | Amitriptyline Hydrochloride – API |
ADI-IMPM-01-00570 | Dibenzosuberone | Imp A | 10,11-Dihydro-5H-dibenzo- [a,d][7]annulen-5-one; Dibenzocycloheptenone; Dibenzosuberan-5-one; Dibenzosuberone; 10,11-Dihydro-5Hdibenzo[a,d] cycloheptatrien-5-one; | 25MG,50MG | Room Temp | 1210-35-1 | 208.26 | C15H12O | 2,3:6,7-Dibenzosuberone; Dibenzo[a,d]cyclohepta[1,4]dien-5- one; Dibenzo[a,d]cycloheptadien-5- one; Amitriptyline Related Compound A; NSC 49727; | Amitriptyline Hydrochloride – Impurity A |
ADI-IMPM-01-00571 | Cyclobenzaprine Hydrochloride | Imp B | 3-(5H-Dibenzo[a,d]cyclohepten-5- ylidene)-N,N-dimethyl-1-propanamine Hydrochloride; Flexeril; Flexiban; | 25MG,50MG | Freezer | 6202-23-9 | 311.85 | C20H22ClN | NA | Amitriptyline Hydrochloride – Impurity B |
ADI-IMPM-01-00572 | Nortriptyline Hydrochloride I | Imp C | 3-(10,11-Dihydro-5Hdibenzo[a,d]cyclohepten-5-ylidene)-Nmethyl-1- propanamine Hydrochloride | 25MG,50MG | Refrigerator | 894-71-3 | 299.84 | C19H22ClN | Acetexa; Allegron; Nortrilen; Norzepine; Pamelor; Sensival; Vividyl; | Amitriptyline Hydrochloride – Impurity C |
ADI-IMPM-01-00573 | 5-[3-(Dimethylamino)propyl]-10,11-dihydro5H-dibenzo[a,d][7]annulen-5-ol | Imp D | 10,11-dihydro-5H-dibenzo[a,d][7]annulen5-ol, 5-[3-(Dimethylamino)propyl]-; | 25MG,50MG | Refrigerator | 1159-03-1 | 295.42 | C20H25NO | Amitriptyline Related Compound B; | Amitriptyline Hydrochloride – Impurity D |
ADI-IMPM-01-00574 | N,N-Dimethyl-3- (1,2,3,4,4a,10,11,11a-octahydro5H-dibenzo[a,d][7]annulen-5- ylidene)propan-1-amine Hydrochloride | Imp E | 3-(2,3,4,4a,11,11a-Hexahydro-1Hdibenzo[a,d][7]annulen-5(10H)- ylidene)-N,N-dimethylpropan-1- amine Hydrochloride; | 25MG,50MG | NA | 27867-02-3 | 319.91 | C20H30ClN | NA | Amitriptyline Hydrochloride – Impurity E |
ADI-IMPM-01-00575 | 0 10-Hydroxy Amitriptyline Oxalate | Imp F | 5-[3-(Dimethylamino)propylidene]- 10,11-dihydro-5Hdibenzo[a,d]cyclohepten-10-ol Oxalate; | 25MG,50MG | Hygroscop ic, Freezer, Under Inert Atmosphe | 1246833-15-7 | 383.44 | C22H25NO5 | (E)-5-(3- (Dimethylamino)propylidene)- 10,11-dihydro-5Hdibenzo[a,d][7]annulen-10-ol Oxalate; | Amitriptyline Hydrochloride – Impurity F (Oxalate Salt) |
ADI-IMPM-01-00576 | 10-Hydroxy Amitriptyline | Imp F | 5-[3-(Dimethylamino)propylidene]- 10,11-dihydro-5Hdibenzo[a,d]cyclohepten-10-ol | 25MG,50MG | NA | 1159-82-6 | 293.4 | C20H23NO | NA | Amitriptyline Hydrochloride – Impurity F (Freebase) |
ADI-IMPM-01-00577 | 10,11-Dihydro-5H-dibenzo[a,d][7]-annulen5-ol | Imp G | Dibenzosuberol; 5-Hydroxy-10,11- dihydro-5H- dibenzo[a,d]cycloheptene; NSC 86157; | 25MG,50MG | NA | 1210-34-0 | 210.27 | C15H14O | NA | Amitriptyline Hydrochloride – Impurity G |
ADI-IMPM-01-00578 | Amitriptyline N-Oxide Hydrochloride | IH | [3-(10,11-Dihydro-5Hdibenzo[a,d][7]annulen-5-ylidene)propyl]- dimethylamine Oxide Hydrochloride; | 25MG,50MG | NA | 4290-60-2 | 329.86 | C20H23NO.ClH | Amitriptyline N-Oxide Hydrochloride, Nortriptyline Hydrochloride Imp. J (EP) as Hydrochloride | Amitriptyline Hydrochloride – In house impurity |
ADI-IMPM-01-00579 | 10,11-Dihydro-5Hdibenzo[a,d]cycloheptene | IH | Dibenzosuberane; 1,2:4,5- Dibenzocycloheptane; | 25MG,50MG | NA | 833-48-7 | 194.27 | C15H14 | 10,11- Dihydrodibenzo[a,d]cycloheptene; 2,3:6,7-Dibenzosuberan; Dibenzo[a,d][1,4]cycloheptadiene; NSC 86156; Suberane; | Amitriptyline Hydrochloride – In house impurity |
ADI-IMPM-01-00580 | Amlodipine | API | 2-[(2-Aminoethoxy)methyl]-4-(2- chlorophenyl)-3-ethoxycarbonyl-5- methoxycarbonyl)-6-methyl-1,4- dihydropyridine; | 25MG,50MG | Freezer | 88150-42-9 | 408.88 | C20H25ClN2O5 | (R,S)-Amlodipine; Amlopres; Intervask; Pelmec; UK-48340; | Amlodipine – API |
ADI-IMPM-01-00581 | Dehydro Amlodipine | Imp D | 2-[(2-Aminoethoxy)methyl]-4-(2- chlorophenyl)-6-methyl-3,5- pyridinedicarboxylic Acid 3-Ethyl 5- Methyl Ester | 25MG,50MG | NA | 113994-41-5 | 406.86 | C20H23ClN2O5 | UK 55-410; Amlodipine Related Compound A; | Amlodipine Besilate (Freebase) – Impurity D |
ADI-IMPM-01-00582 | Amlodipine Azido Impurity | IH | Amlodipine Azido Analog; 3-Ethyl 5- methyl 2-[(2-azidoethoxy)methyl]-4-(2- chlorophenyl)-6-methyl-1,4- dihydropyridine-3,5-dicarboxylate; | 25MG,50MG | Refregerator | 88150-46-3 | 434.87 | C20H23ClN4O5 | 2-[(2-Azidoethoxy)methyl]-4-(2- chlorophenyl)-1,4-dihydro-6-methyl3,5-pyridinedicarboxylic Acid 3- Ethyl 5-Methyl Ester; 2-[(2- Azidoethoxy)methyl]-4-(2- chlorophenyl)-3-ethoxycarbonyl-5- methoxycarbonyl)-6-methyl-1,4- dihydropyridine; | Amlodipine – In house impurity |
ADI-IMPM-01-00583 | Amlodipine 4-chloro Isomer | IH | 3-Ethyl 5-methyl 2-[(2- aminoethoxy)methyl]-4-(4- chlorophenyl)-6-methyl-1,4- dihydropyridine-3,5-dicarboxylate; 6-Methyl-1,4-dihydropyridine-3,5- dicarboxylate, 3-ethyl 5-methyl 2- ((2-aminoethoxy)methyl)-4-(4- | 25MG,50MG | NA | NA | 408.88 | C20H25ClN2O5 | NA | Amlodipine – In house impurity |
ADI-IMPM-01-00584 | (R)-Amlodipine | IH | (4R)-2-[(2-Aminoethoxy)methyl]-4- (2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylic Acid 3-Ethyl 5-Methyl Ester; (+)- Amlodipine; | 25MG,50MG | Freezer | 103129-81-3 | 408.88 | C20H25ClN2O5 | (R)-(+)-Amlodipine; dAmlodipine; | Amlodipine – In house impurity |
ADI-IMPM-01-00585 | 2-((2-Aminoethoxy)methyl)-4-(2- chlorophenyl)-6-methyl-1,4- dihydropyridine-3,5-dicarboxylic Acid | IH | Amlodipine Impurity 18; | 25MG,50MG | NA | NA | 366.8 | 0 C17H19ClN2O5 | NA | Amlodipine – In house impurity |
ADI-IMPM-01-00586 | Amlodipine N-Galactopyranoside | IH | Amlodipine Galactose Adduct; 2- [[2-[(DGalactopyranosyl)amino]ethoxy] methyl]-4-(2-chlorophenyl)-1,4- dihydro-6-methyl-3,5- pyridinedicarboxylic Acid 3-Ethyl 5-Methyl Ester; | 25MG,50MG | Freezer | NA | 571.02 | C26H35ClN2O10 | Amlodipine N-Galactose; | Amlodipine – In house impurity |
ADI-IMPM-01-00587 | Amlodipine Besilate | API | 2-[(2-Aminoethoxy)methyl]-4-(2- chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylic Acid 3-Ethyl 5- Methyl Ester Benzenesulfonate; Amlodipine Besylate; | 25MG,50MG | Freezer | 111470-99-6 | 567.05 | C26H31ClN2O8S | Amdepin; Amdipin; Amlodin; Norvasc; UK 48340-26; Vazkor; | Amlodipine Besilate – API |
ADI-IMPM-01-00588 | Phthaloyl Amlodipine | Imp A | 4-(2-Chlorophenyl)-2-[[2-(1,3-dihydro-1,3- dioxo-2H-isoindol-2-yl)ethoxy]methyl]-1,4- dihydro-6-methyl-3,5-pyridinedicarboxylic Acid 3-Ethyl 5-Methyl Ester; | 25MG,50MG | Refrigerator | 88150-62-3 | 538.98 | C28H27ClN2O7 | 4-(2-Chlorophenyl)-3- (ethoxycarbonyl)-5- (methoxycarbonyl)-6-methyl-2-[(2- phthalimidoethoxy)methyl]-1,4- dihydropyridine; 3-Ethyl 5-methyl 4- (2-chlorophenyl)-2-{[2-(1,3- dioxoisoindolin-2-yl)ethoxy]methyl}- 6-methyl-1,4-dihydropyridine-3,5- dicarboxylate; Amlodipine Related Compound D; | Amlodipine Besilate – Impurity A |
ADI-IMPM-01-00589 | 3-Ethyl 5-methyl 4-(2-chlorophenyl)-6- methyl-2-[[2-[[2- (methylcarbamoyl)benzoyl]amino]ethoxy] methyl]-1,4- dihydropyridine-3,5- dicarboxylate | Imp B | 4-(2-Chlorophenyl)-1,4-dihydro-2-methyl6-[[2-[[2- [(methylamino)carbonyl]benzoyl]amino]et hoxy]methyl]-5-pyridinedicarboxylic Acid 5-Ethyl 3-Methyl Ester; |
25MG,50MG | NA | 721958-72-1 | 570.03 | C29H32ClN3O7 | 3-Ethyl 5-Methyl (4RS)-4-(2- Chlorophenyl)-6-methyl-2-[[2-[[2- (methylcarbamoyl)benzoyl]amino]e thoxy]methyl]-1,4-dihydropyridine3,5-dicarboxylate; | Amlodipine Besilate – Impurity B |
ADI-IMPM-01-00590 | Bis(aminoethoxy) Amlodipine | Imp C | 2,6-Bis[(2-aminoethoxy)methyl]-4-(2- chlorophenyl)-1,4-dihydro-3,5- pyridinedicarboxylic Acid 3-Ethyl 5- Methyl Ester; | 25MG,50MG | NA | 721958-74-3 | 467.94 | C22H30ClN3O6 | Ethyl methyl 2,6-bis[(2- aminoethoxy)methyl]-4-(2- chlorophenyl)-1,4-dihydropyridine3,5-dicarboxylate; | Amlodipine Besilate – Impurity C |
ADI-IMPM-01-00591 | Dehydro Amlodipine Oxalate | Imp D | 2-[(2-Aminoethoxy)methyl]-4-(2- chlorophenyl)-6-methyl-3,5- pyridinedicarboxylic Acid 3-Ethyl 5- Methyl Ester Oxalate; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 1216406-90-4 | 496.89 | C22H25ClN2O9 | 2-(2-Amino-ethoxymethyl)-4-(2- chloro-phenyl)-6-methyl-pyridine3,5-dicarboxylic Acid 3-ethyl Ester; | Amlodipine Besilate – Impurity D |
ADI-IMPM-01-00592 | Amlodipine Diethyl Ester | Imp E | Diethyl 2-((2-Aminoethoxy)methyl)-4-(2- chlorophenyl)-6-methyl-1,4- dihydropyridine-3,5-dicarboxylate; 3- Ethyl 5-Ethyl 4-(2-Chlorophenyl)-6- methyl-2-[[2- [(2-aminoethoxy)methyl]- 1,4-dihydropyridine-3,5-dicarboxylate; Amlodipine Ethyl Analog; | 25MG,50MG | NA | 140171-65-9 | 422.9 | C21H27ClN2O5 | 2-[(2-Aminoethoxy)methyl]-4-(2- chlorophenyl)-1,4-dihydro-6-methyl3,5-pyridinedicarboxylic Acid 3,5- Diethyl Ester; Amlodipine Related Compound E; | Amlodipine Besilate – Impurity E |
ADI-IMPM-01-00593 | Amlodipine Dimethyl Ester | Imp F | 2-[(2-Aminoethoxy)methyl]-4-(2- chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylic Acid 3,5-dimethyl Ester; | 25MG,50MG | NA | 140171-66-0 | 394.85 | C19H23ClN2O5 | 3-Methyl 5-Methyl 4-(2- Chlorophenyl)-6-methyl-2-[[2- [(2- aminoethoxy)methyl]-1,4- dihydropyridine-3,5-dicarboxylate; Amlodipine Related Compound F | Amlodipine Besilate – Impurity F |
ADI-IMPM-01-00594 | Dimethyl 4-(2-Chlorophenyl)-2,6-dimethyl1,4-dihydro-pyridine-3,5-dicarboxylate | Imp G | 4-(2-Chlorophenyl)-1,4-dihydro-2,6- dimethyl-3,5-pyridinedicarboxylic Acid 3,5-Dimethyl Ester; | 25MG,50MG | NA | 43067-01-2 | 335.78 | C17H18ClNO4 | 4-(2-Chlorophenyl)-3,5- di(methoxycarbonyl)-2,6-dimethyl1,4- dihydropyridine; | Amlodipine Besilate – Impurity G |
ADI-IMPM-01-00595 | 2-Carboxybenzoyl Amlodipine | Imp H | 2-[[2-[(2- Carboxybenzoyl)amino]ethoxy]methyl]-4- (2-chlorophenyl)-1,4-dihydro-6-methyl3,5-pyridinedicarboxylic Acid 3-Ethyl 5- Methyl Ester; | 25MG,50MG | NA | 318465-73-5 | 556.99 | C28H29ClN2O8 | 2-[[2-[[(4R)-4-(2-Chlorophenyl)-3- (ethoxycarbonyl)-5- (methoxycarbonyl)-6-methyl-1,4- dihydropyridin-2- yl]methoxy]ethyl]carbamoyl]benzoi c Acid; | Amlodipine Besilate – Impurity H |
ADI-IMPM-01-00596 | Amlodipine N-Lactoside | IH | Amlodipine Besylate Glycosyl; 2-[[2-[(4- O-β-D-Galactopyranosyl-Dglucopyranosyl)amino]ethoxy]methyl]-4- (2-chlorophenyl)-1,4-dihydro-6-methyl3,5-pyridinedicarboxylic Acid 3-Ethyl 5- Methyl Ester; Amlodipine Lactose Adduct; | 25MG,50MG | NA | NA | 733.16 | C32H45ClN2O15 | 3-Ethyl 5-methyl 4-(2- chlorophenyl)-2-((2- (((3R,4R,5S,6R)-3,4-dihydroxy-6- (hydroxymethyl)-5- (((2S,3R,4S,5R,6R)-3,4,5- trihydroxy-6- (hydroxymethyl)tetrahydro-2Hpyran-2-yl)oxy)tetrahydro-2H-pyran | Amlodipine Besilate – In house impurity |
ADI-IMPM-01-00597 | Amlodipine Methyl Monoester Impurity | IH | 3,5-Pyridinedicarboxylic Acid, 2- [(2-aminoethoxy)methyl]-4-(2- chlorophenyl)-1,4-dihydro-6- methyl-, 5-methyl Ester; 2-((2- Aminoethoxy)methyl)-4-(2- chlorophenyl)-5- (methoxycarbonyl)-6-methyl-1,4 | 25MG,50MG | NA | 1809326-44-0 | 380.82 | C18H21ClN2O5 | NA | Amlodipine Besilate – In house impurity |
ADI-IMPM-01-00598 | Amlodipine Ethyl Monoester Impurity | IH | 3,5-Pyridinedicarboxylic acid, 2- [(2-aminoethoxy)methyl]-4-(2- chlorophenyl)-1,4-dihydro-6- methyl-, 3-ethyl Ester; 6-((2- Aminoethoxy)methyl)-4-(2- chlorophenyl)-5-(ethoxycarbonyl)- 2-methyl-1,4-dihydropyridine-3- | 25MG,50MG | NA | 113994-37-9 | 394.85 | C19H23ClN2O5 | NA | Amlodipine Besilate – In house impurity |
ADI-IMPM-01-00599 | Amlodipine Maleate | API | 3-Ethyl 5-methyl 2-((2- aminoethoxy)methyl)-4-(2-chlorophenyl)- 6-methyl-1,4-dihydropyridine-3,5- dicarboxylate Maleate; 3-Ethyl 5-methyl (+-)-2-((2-aminoethoxy)methyl)-4-(ochlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, maleate (1:1) | 25MG,50MG | Refrigerator, under inert atmosphere | 88150-47-4 | 524.95 | C24H29ClN2O9 | 2-[(2-Aminoethoxy)methyl]-4-(2- chlorophenyl)-1,4-dihydro-6-methyl3,5-pyridinedicarboxylic acid 3- ethyl 5-methyl ester (Z)-2- butenedioate; | Amlodipine Maleate – API |
ADI-IMPM-01-00600 | Amlodipine Mesilate | API | 3-Ethyl 5-methyl 2-((2- aminoethoxy)methyl)-4-(2-chlorophenyl)- 6-methyl-1,4-dihydropyridine-3,5- dicarboxylate Methanesulfonate; | 25MG,50MG | NA | 246852-12-0 | 504.98 | C21H29ClN2O8S | NA | Amlodipine Maleate – API |
ADI-IMPM-01-00601 | Ammonium Glycyrrhizinate | API | (3β,20β)-20-Carboxy-11-oxo-30- norolean-12-en-3-yl 2-O-β-Dglucopyranuronosyl- α-Dglucopyranosiduronic Acid Ammonium Salt; (3β,20β)-20-Carboxy-11-oxo-30- norolean-12-en-3-yl-2-O-β-DGlucopyranuronosyl-α-DGlucopyranosiduronic Acid Monoammonium Salt; | 25MG,50MG | NA | 53956-04-0 | 839.96 | C42H65NO16 | (+)-Glycyram; 18β-Glycyrrhizic acid Monoammonium Salt; Ammonium Glycyrrhizate; Glycamil; Glycymin; Glycyron Ammonium Salt; Glycyron monoammonium salt; Glycyrram; Glycyrrhizic Acid Ammonium Salt; | Ammonium Glycyrrhizinate – API |
ADI-IMPM-01-00602 | Amodiaquine Dihydrochloride Dihydrate | API | 4-[(7-Chloro-4-quinolinyl)amino]-2- [(diethylamino)methyl]phenol Dihydrochloride Dihydrate; 4-[(7-chloro-4- quinolyl)amino]-α-(diethylamino)-cresol Dihydrochloride Dihydrate; | 25MG,50MG | NA | 6398-98-7 | 464.81 | C20H28Cl3N3O3 | Amodiaquin Dihydrochloride Dihydrate; 4-((7-Chloroquinolin-4- yl)amino)-2- ((diethylamino)methyl)phenol Dihydrochloride Dihydrate; | Amodiaquine Dihydrochloride Dihydrate – API |
ADI-IMPM-01-00603 | 4,7-Dichloroquinoline | IH | NSC 593; | 25MG,50MG | NA | 86-98-6 | 198.05 | C9H5Cl2N | NA | Amodiaquine Dihydrochloride Dihydrate – In house impurity |
ADI-IMPM-01-00604 | 3-Diethylamino Acetaminophen | IH | 4-Acetamido-2- diethylaminomethylphenol; N-(3- ((Diethylamino)methyl)-4- hydroxyphenyl)acetamide; | 25MG,50MG | NA | 121-78-8 | 236.31 | C13H20N2O2 | NA | Amodiaquine Dihydrochloride Dihydrate – In house impurity |
ADI-IMPM-01-00605 | 7-Chloro-4-(4-hydroxyanilino)quinoline | IH | p-[(7-Chloro-4-quinolyl)amino]phenol; 7- chloro-4-p-hydroxyanilinoquinoline; | 25MG,50MG | NA | 81099-86-7 | 270.71 | C15H11ClN2O | 4-(7-Chloroquinolin-4- ylamino)phenol; NSC 12488; NSC 130792; | Amodiaquine Dihydrochloride Dihydrate – In house impurity |
ADI-IMPM-01-00606 | Amonafide | API | 5-Amino-2-[2-(dimethylamino)ethyl]-1Hbenz[de]isoquinoline-1,3(2H)-dione; | 25MG,50MG | freezer | 69408-81-7 | 283.33 | C16H17N3O2 | FA 142; M-FA 142; MADE-FA 142; NCI 308847; NSC 308847; Nafidimide; | Amonafide – API |
ADI-IMPM-01-00607 | N-Acetyl Amonafide | IH | N-[2-[2-(Dimethylamino)ethyl]-2,3- dihydro-1,3-dioxo-1H-benz[de]isoquinolin5-yl]acetamide; | 25MG,50MG | Refregerator | 69409-02-5 | 325.36 | C16H17N3O2 | MADE-FA 4512; NAcetylamonafide; | Amonafide – In house impurity |
ADI-IMPM-01-00608 | Amorolfine Hydrochloride | API | (2R,6S)-rel-4-[3-[4-(1,1- Dimethylpropyl)phenyl]-2- methylpropyl]-2,6-dimethylmorpholine Hydrochloride; cis-4- [3-[4-(1,1-Dimethylpropyl)phenyl]- 2-methylpropyl]-2,6-dimethylmorpholine Hydrochloride; | 25MG,50MG | Refregerator | 78613-38-4 | 353.97 | C21H36ClNO | NA | Amorolfine Hydrochloride – API |
ADI-IMPM-01-00609 | Amoxicillin Trihydrate | API | Amoxicillin; (2S,5R,6R)-6-[[(2R)-2-Amino2-(4-hydroxyphenyl)acetyl]amino]-3,3- dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylic Acid; | 25MG,50MG | Freezer | 61336-70-7 | 419.45 | C16H25N3O8S | AMPC; Amoxillat; Ardine; Helvamox; Pasetocin; Penimox; Zamocillin; | Amoxicillin Trihydrate – API |
ADI-IMPM-01-00610 | 6-Aminopenicillanic Acid | Imp A | 2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo4-thia-1-azabicyclo[3.2.0]heptane-2- carboxylic Acid;6-APA; 6-APS; 6βAminopenicillanic Acid; | 25MG,50MG | Freezer | 551-16-6 | 216.26 | C8H12N2O3S | NSC 50071; [2S-(2α,5α,6β)]-6- Amino-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2- carboxylic Acid; 6- Aminopenicillinate; Amoxicillin Related Compound A; | Amoxicillin Trihydrate – Impurity A |
ADI-IMPM-01-00611 | L-Amoxicillin | Imp B | (2S,5R,6R)-6-[[(2S)-2-Amino-2-(4- hydroxyphenyl)acetyl]amino]-3,3- dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylic Acid; | 25MG,50MG | NA | 26889-93-0 | 365.4 | C16H19N3O5S | Amoxicillin Related Compound B | Amoxicillin Trihydrate – Impurity B |
ADI-IMPM-01-00612 | Amoxicillin Diketopiperazine | Imp C | 2-[5-(4-Hydroxyphenyl)-3,6-dioxo-2- piperazinyl]-5,5-dimethyl-4- thiazolidinecarboxylic Acid; | 25MG,50MG | Freezer | 94659-47-9 | 365.4 | C16H19N3O5S | 2,5-Amoxipiperazinedione; Amoxicillin Piperazine-2,5-dione; Amoxicillin Related Compound C; | Amoxicillin Trihydrate – Impurity C |
ADI-IMPM-01-00613 | Penicilloic Acids of Amoxicillin Sodium Salt | Imp D | α-[[Amino(4-hydroxyphenyl)acetyl]amino]- 4-carboxy-5,5-dimethyl-2-thiazolidine Acetic Acid Monosodium Salt; | 25MG,50MG | NA | 68728-47-2 | 405.4 | C16H20N3NaO6S | (4S)-2-[[[(2R)-2-Amino-2-(4- hydroxyphenyl)acetyl]amino]- carboxymethyl]-5,5- dimethylthiazolidine-4-carboxylic Acid Sodium Salt; Amoxicillin Related Compound D; | Amoxicillin Trihydrate – Impurity D |
ADI-IMPM-01-00614 | Penilloic Acids of Amoxicillin | Imp E | (2RS,4S)-2-[[[(2R)-2-Amino-2-(4- hydroxyphenyl)acetyl]amino]methyl]-5,5- dimethylthiazolidine-4-carboxylic Acid; | 25MG,50MG | NA | 1356020-01-3 | 339.41 | C15H21N3O4S | 2-{[2-Amino-2-(4-hydroxy-phenyl)- acetylamino]-methyl}-5,5-dimethylthiazolidine-4-carboxylic acid; | Amoxicillin Trihydrate – Impurity E |
ADI-IMPM-01-00615 | 3-(4-hydroxyphenyl)pyrazin-2-ol | Imp F | 2-ol, 3-(4-hydroxyphenyl)pyrazin-; Amoxicillin Related Compound F; | 25MG,50MG | NA | 126247-63-0 | 188.18 | C10H8N2O2 | NA | Amoxicillin Trihydrate – Impurity F |
ADI-IMPM-01-00616 | 0 p-Hydroxy-(D)-phenylglycyl Amoxicillin | Imp G | (2R)-(2R)-2-(4-hydroxyphenyl)glycyl-N- [(2S,5R,6R)-2-carboxy-3,3-dimethyl-7- oxo-4-thia-1-azabicyclo[3.2.0]hept-6-yl]-2- (4-hydroxyphenyl)glycinamide; | 25MG,50MG | NA | 188112-75-6 | 514.55 | C24H26N4O7S | Amoxicillin Related Compound G; | Amoxicillin Trihydrate – Impurity G |
ADI-IMPM-01-00617 | (R)-α-[(2,2-Dimethyl-1-oxopropyl)amino]-4- hydroxybenzeneacetic Acid | Imp H | H (2R)-2-[(2,2-Dimethylpropanoyl)amino]-2- (4-hydroxyphenyl)acetic acid; | 25MG,50MG | NA | 205826-86-4 | 251.28 | C13H17NO4 | NA | Amoxicillin Trihydrate – Impurity H |
ADI-IMPM-01-00618 | (2R)-2-Amino-2-(4-hydroxyphenyl)acetic Acid | Imp I | (αR)-α-Amino-4-hydroxybenzeneacetic Acid; R)-(4-Hydroxyphenyl)glycine; (R)-2- (4-Hydroxyphenyl)glycine; (R)-Ethyl 2- Amino-2-(4-hydroxyphenyl)acetate; (αR)- α-Amino-4-hydroxybenzeneacetic acid; 4- Hydroxy-D-phenylglycine; D-(-)-2-(4- Hydroxyphenyl)glycine; | 25MG,50MG | Refrigerator | 22818-40-2 | 167.16 | C8H9NO3 | D-(-)-2-(p-Hydroxyphenyl)glycine; D-(-)-4-Hydroxyphenylglycine; D-(- )-Amino(4-hydroxyphenyl)acetic Acid; D-(-)-pHydroxyphenylglycine; D-(-)-α-(4- Hydroxyphenyl)glycine; D-(-)-αAmino-4-hydroxyphenylacetic Acid; D-(-)-α-Amino-phydroxyphenylacetic Acid; D-2-(4- | Amoxicillin Trihydrate – Impurity I |
ADI-IMPM-01-00619 | (4S)-2-[1-[[(2R)-2-Amino-2-(4- hydroxyphenyl)acetyl]amino]-2- [[(1R)-2-[[carboxy[(4S)- 4-carboxy-5,5-dimethyl-1,3- thiazolidin-2-yl]methyl]amino]-1-(4- hydroxyphenyl)-2- oxoethyl]amino]-2-oxoethyl]-5,5- dimethyl-1,3-thiazolidine-4- carboxylic Acid; |
Imp K | (4S)-2-(1-((R)-2-Amino-2-(4- hydroxyphenyl)acetamido)-2- (((1R)-2-((carboxy((4S)-4-carboxy5,5-dimethylthiazolidin-2- yl)methyl)amino)-1-(4- hydroxyphenyl)-2- oxoethyl)amino)-2-oxoethyl)-5,5- dimethylthiazolidine-4-carboxylic Acid; Open Dimer Impurity; | 25MG,50MG | NA | NA | 748.82 | C32H40N6O11S2 | NA | Amoxicillin Trihydrate – Impurity K |
ADI-IMPM-01-00620 | APA Amoxicillin Amide | Imp L | (2S,5R,6R)-6-[[(2S,5R,6R)-6-[[(2R)-2- amino-2-(4-hydroxyphenyl)acetyl]amino]- 3,3- dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2- carbonyl]amino]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2- carboxylic Acid; 6-APA amoxicillin amide; | 25MG,50MG | Freezer | NA | 563.65 | C24H29N5O7S2 | NA | Amoxicillin Trihydrate – Impurity L |
ADI-IMPM-01-00621 | (2S,5R,6R)-6-[[(2R,8R,14R)-14- Amino-5,11-bis[(4S)-4-carboxy-5,5- dimethyl-1,3-thiazolidin-2- yl]-2,8,14-tris(4-hydroxyphenyl)- 4,7,10,13-tetraoxo-3,6,9,12- tetraazatetradecan-1-oyl]amino]- 3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2- carboxylic Acid |
Imp M | Amoxicillin Trimer Impurity; (4S,4’S)-2,2′-((1R,7R,13R)-1- Amino-14-(((2S,5R,6R)-2-carboxy3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptan-6- yl)amino)-1,7,13-tris(4- hydroxyphenyl)-2,5,8,11,14- pentaoxo-3,6,9,12- tetraazatetradecane-4,10- diyl)bis(5,5-dimethylthiazolidine-4- | 25MG,50MG | NA | NA | 1096.21 | C48H57N9O15S3 | NA | Amoxicillin Trihydrate – Impurity M |
ADI-IMPM-01-00622 | (2R)-2-Amino-2-(4-hydroxyphenyl) Acetamide | IH | (2R)-2-Amino-2-(4- hydroxyphenyl)acetamide; (R)-2-Amino2-(4-hydroxyphenyl)acetamide; | 25MG,50MG | NA | 54397-23-8 | 166.18 | C8H10N2O2 | NA | Amoxicillin Trihydrate – In house impurity |
ADI-IMPM-01-00623 | Amoxicillin Dimer | Imp J | (2R)-(2R)-2-(4-Hydroxyphenyl)glycyl- (2S)-2-[(2R,4S)-4-carboxy-5,5-dimethyl2-thiazolidinyl]glycyl-N-[(2S,5R,6R)-2- carboxy-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]hept-6-yl]-2-(4- hydroxyphenyl)glycinamide; | 25MG,50MG | NA | 73590-06-4 | 730.81 | C32H38N6O10S2 | [2(2R-trans),3[2S-(2α,5α,6β)]]-D-2- (4-hydroxyphenyl)glycyl-L-2-(4- carboxy-5,5-dimethyl-2- thiazolidinyl)glycyl-N-(2-carboxy3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]hept-6-yl)-D-2-(4- hydroxyphenyl)glycinamide; coOligomers of Amoxicillin and of Penicilloic Acids of Amoxicillin; Amoxicillin Related Compound J; |
Amoxicillin Trihydrate – Impurity J |
ADI-IMPM-01-00624 | Amoxicillin Trimer | IH | (2R)-(2R)-2-(4-Hydroxyphenyl)glycyl- (2R)-2-[(2R,4S)-4-carboxy-5,5-dimethyl2-thiazolidinyl]glycyl-(2R)-2-(4- hydroxyphenyl)glycyl-(2R)-2-[(2R,4S)-4- carboxy-5,5-dimethyl-2- thiazolidinyl]glycyl-N-[(2S,5R,6R)-2- carboxy-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]hept-6-yl]-2-(4- hydroxyphenyl)glycinamide; |
25MG,50MG | NA | 174391-69-6 | 1096.21 | C48H57N9O15S3 | [2(2R-trans),4(2R-trans),5[2S- (2α,5α,6β)]]-D-2-(4- Hydroxyphenyl)glycyl-L-2-(4- carboxy-5,5-dimethyl-2- thiazolidinyl)glycyl-D-2-(4- hydroxyphenyl)glycyl-L-2-(4- carboxy-5,5-dimethyl-2- thiazolidinyl)glycyl-N-(2-carboxy3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]hept-6-yl)-D-2-(4- hydroxyphenyl)gly |
Amoxicillin Trihydrate – In house impurity |
ADI-IMPM-01-00625 | N-Pivaloyl Amoxicillin | IH | N-(2,2,Dimethyl-1-oxopropyl)-Amoxicillin; (2S,5R,6R)-6-[[(2R)-2-[(2,2-Dimethyl-1- oxopropyl)amino]-2-(4- hydroxyphenyl)acetyl]amino]-3,3- dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylic Acid; | 25MG,50MG | NA | 1313237-94-3 | 449.52 | C21H27N3O6S | NA | Amoxicillin Trihydrate – In house impurity |
ADI-IMPM-01-00626 | (R)-Methyl 2-amino-2-(4- hydroxyphenyl)acetate | IH | Hydroxy Phenyl Glycine Methyl Ester; (R)-Amino-(4- hydroxyphenyl)acetic Acid Methyl Ester; | 25MG,50MG | NA | 37763-23-8 | 181.19 | C9H11NO3 | Methyl D-4- hydroxyphenylglycine; Methyl D-2-phydroxyphenylglycine; αAmino-4-hydroxy | Amoxicillin Trihydrate – In house impurity |
ADI-IMPM-01-00627 | Amphotericin B | API | Abelcet; Abelecet; AmBisome; AmphoMoronal; Amphocin; Amphozone; Apothecon; Fungilin; Fungizona; Fungizone; Halizon; LNS-AmB; NS 718; NSC 527017; | 25MG,50MG | Freezer | 1397-89-3 | 924.08 | C47H73NO17 | NA | Amphotericin B – API |
ADI-IMPM-01-00628 | Amphotericin B Methyl Ester | IH | Amphotericin B Monomethyl Ester; | 25MG,50MG | Freezer | 36148-89-7 | 938.11 | C48H75NO17 | NA | Amphotericin B – In house impurity |
ADI-IMPM-01-00629 | Ampicillin Sodium | API | D-(-)-6-(2-Amino-2-phenylacetamido)- 3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylic Acid Monosodium Salt; Binotal Sodium; Britapen Injection; Cilleral; D-αAminobenzylpenicillin Sodium Salt; Ampicillin Sodium Salt; Ampicillin-Na; Ampicin; Anhypen; | 25MG,50MG | NA | 69-52-3 | 371.39 | C16H18N3NaO4S | [2S-[2α,5α,6β(S*)]]-6- [(Aminophenylacetyl)amino]-3,3- dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2- carboxylic Acid Monosodium Salt; (2S,5R,6R)-6-[[(2R)- Aminophenylacetyl]amino]-3,3- dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2- carboxylic Acid Monosodium Salt; Alpen N; Amcill S; Ampi-Dry 5000; Ampicillin Sodium; |
Ampicillin Trihydrate – API |
ADI-IMPM-01-00630 | Ampicillin Trihydrate | API | D-(−)-α-Aminobenzylpenicillin; | 25MG,50MG | NA | 7177-48-2 | 403.45 | C16H19N3O4S.3H2O | NA | Ampicillin Trihydrate – API |
ADI-IMPM-01-00631 | 6-Aminopenicillanic Acid | Imp A | (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo4-thia-1-azabicyclo[3.2.0]heptane-2- carboxylic Acid;6-APA; 6-APS; 6βAminopenicillanic Acid; | 25MG,50MG | Freezer | 551-16-6 | 216.26 | C8H12N2O3S | NSC 50071; [2S-(2α,5α,6β)]-6- Amino-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2- carboxylic Acid; 6- Aminopenicillinate; Amoxicillin Related Compound A; | Ampicillin Trihydrate – Impurity A |
ADI-IMPM-01-00632 | L-Ampicillin | Imp B | (2S,5R,6R)-6-[[(2S)-2-Amino-2- phenylacetyl]amino]-3,3-dimethyl-7-oxo4-thia-1-azabicyclo[3.2.0]heptane-2- carboxylic Acid; | 25MG,50MG | NA | 19379-33-0 | 349.4 | C16H19N3O4S | NA | Ampicillin Trihydrate – Impurity B |
ADI-IMPM-01-00633 | Diketopiperazines of Ampicillin | Imp C | 2-(3,6-Dioxo-5-phenyl-2-piperazinyl)-5,5- dimethyl-4-thiazolidinecarboxylic Acid; | 25MG,50MG | NA | 49841-96-5 | 349.4 | C16H19N3O4S | (4S)-2-(3,6-dioxo-5- phenylpiperazin-2-yl)-5,5- dimethylthiazolidine-4-carboxylic acid; NSC 362657; | Ampicillin Trihydrate – Impurity C |
ADI-IMPM-01-00634 | Penicilloic Acids of Ampicillin Sodium Salt | Imp D | (4S)-2-[[[(2R)-2-Amino-2- phenylacetyl]amino]carboxymethyl]-5,5- dimethylthiazolidine-4-carboxylic Acid Sodium Salt; | 25MG,50MG | NA | NA | 389.4 | C16H20N3NaO5S | Sodium (4S)-2-(((R)-2-Amino-2- phenylacetamido)(carboxy)methyl)- 5,5-dimethylthiazolidine-4- carboxylate; | Ampicillin Trihydrate – Impurity D |
ADI-IMPM-01-00635 | Ampicillinyl-D-phenylglycine | Imp E ‘ | 2R)-2-[[[(2S,5R,6R)-6-[[(2R)-2-amino-2- phenylacetyl]amino]-3,3-dimethyl-7-oxo4-thia-1-azabicyclo[3.2.0]hept-2- yl]carbonyl]amino]-2-phenylacetic Acid; | 25MG,50MG | NA | 1207726-28-0 | 482.56 | C24H26N4O5S | 2R)-2-[[[(2S,5R,6R)-6-[[(2R)-2- amino-2-phenylacetyl]amino]-3,3- dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]hept-2- yl]carbonyl]amino]-2-phenylacetic acid; |
Ampicillin Trihydrate – Impurity E |
ADI-IMPM-01-00636 | Penilloic Acids of Ampicillin | Imp F | (2RS,4S)-2-[[[(2R)-2-Amino-2- phenylacetyl]amino]methyl]-5,5- dimethylthiazolidine-4-carboxylic Acid; |
25MG,50MG | Freezer, Under Dark Atmosphere | 124774-48-7 and 124774-49-8 | 323.41 | C15H21N3O3S | NA | Ampicillin Trihydrate – Impurity F |
ADI-IMPM-01-00637 | (3R,6R)-3,6-Diphenylpiperazine2,5-dione | Imp G | R,6R)-3,6-diphenylpiperazine-2,5-dio | 25MG,50MG | NA | 31485-02-6 | 266.3 | C16H14N2O2 | NA | Ampicillin Trihydrate – Impurity G |
ADI-IMPM-01-00638 | 3-Phenylpyrazine-2-ol | Imp H | 3-Phenyl-1H-pyrazin-2-one; 3-Phenyl-2- pyrazinol; | 25MG,50MG | Refrigerator | 2882-18-0 | 172.18 | C10H8N2O | NA | Ampicillin Trihydrate – Impurity H |
ADI-IMPM-01-00639 | D-Phenylglycylampicillin | Imp I | (2S,5R,6R)-6-[[(2R)-2-[[(2R)-2- amino-2-phenylacetyl]amino]-2- phenylacetyl]amino]-3,3-dimethyl7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2- carboxylic Acid; | 25MG,50MG | NA | 10001-82-8 | 482.56 | C24H26N4O5S | NA | Ampicillin Trihydrate – Impurity I |
ADI-IMPM-01-00640 | (2S,5R,6R)-6-[(2,2- Dimethylpropanoyl)amino]-3,3- dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2- carboxylic Acid | Imp J | (2S,5R,6R)-3,3-Dimethyl-7-oxo-6- pivalamido-4-thia-1- azabicyclo[3.2.0]heptane-2- carboxylic Acid; | 25MG,50MG | NA | 6489-58-3 | 300.38 | C13H20N2O4S | NA | Ampicillin Trihydrate – Impurity J |
ADI-IMPM-01-00641 | (2R)-2-[(2,2-Dimethylpropanoyl)amino]-2- phenylacetic Acid | Imp K | (R)-2-Phenyl-2-pivalamidoacetic Acid; | 25MG,50MG | NA | 40610-41-1 | 235.28 | C13H17NO3 | NA | Ampicillin Trihydrate – Impurity K |
ADI-IMPM-01-00642 | (2R)-2-Amino-2-phenylacetic Acid | Imp L | (-)-(R)-Phenylglycine; (-)-Phenylglycine; (2R)-Amino-2-phenylethanoic Acid; (R)-(- )-2-Phenylglycine; (R)-2-Amino-2- phenylacetic Acid; D-α-Phenylglycine; D2-Phenylglycine; (R)-αAminobenzeneacetic Acid; (αR)-αAminobenzeneacetic Ac; D-2- Phenylglycine; D-C-Phenylglycine; DPhenylglycine; D-α-Aminophenylacetic Acid; |
25MG,50MG | Room Temp | 875-74-1 | 151.16 | C8H9NO2 | (R)-2-Amino-2-phenylethanoic Acid; (R)-2-Phenyl-2- aminoethanoic Acid; (R)-2- Phenylglycine; (R)-2- Phenylglycine; (R)-Phenylglycine; (R)-Phenylglycine; (R)-αPhenylglycine; D-(-)- Aminophenylacetic Acid; D-(-)- Phenylglycine; D-(-)-αAminophenylacetic Acid; D-(-)-αPhenylglycine; | Ampicillin Trihydrate – Impurity L |
ADI-IMPM-01-00643 | 6-{2-[2-(2-Amino-2-phenylacetylamino)-2-(4-carboxy-5,5- dimethyl-thiazolidin-2-yl)- acetylamino]-2-phenylacetylamino}-3,3-dimethyl-7-oxo-4- thia-1-aza-bicyclo[3.2.0]heptane-2- carboxylic Acid | Imp M | Co-oligomers of Ampicillin and of Penicilloic Acids of Ampicillin; Ampicillin Dimer; | 25MG,50MG | Room Temp | NA | 698.22 | C32H38N6O8S2 | NA | Ampicillin Trihydrate – Impurity M |
ADI-IMPM-01-00644 | (3S)-6-[[(2R)-2-Amino-2- phenylacetyl]amino]-2,2-dimethyl7-oxo-2,3,4,7-tetrahydro-1,4- thiazepine-3-carboxylic Acid | Imp N | (S)-6-((R)-2-Amino-2- phenylacetamido)-2,2-dimethyl-7- oxo-2,3,4,7-tetrahydro-1,4- thiazepine-3-carboxylic Acid; | 25MG,50MG | Room Temp | NA | 349.41 | C16H19N3O4S | NA | Ampicillin Trihydrate – Impurity N |
ADI-IMPM-01-00645 | Ampicillin Trimer | IH | (4S,4’S)-2,2′-((1R,7R,13S)-1- Amino-14-(((2S,5R,6R)-2-carboxy3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptan-6- yl)amino)-2,5,8,11,14-pentaoxo1,7,13-triphenyl-3,6,9,12- tetraazatetradecane-4,10- diyl)bis(5,5-dimethylthiazolidine-4- carboxylic Acid); Ampicillin Impurity 2; | 25MG,50MG | NA | NA | 1048.21 | C48H57N9O12S3 | NA | Ampicillin Trihydrate – In house impurity |
ADI-IMPM-01-00646 | Ampicillin Open Ring Dimer | IH | (2R,4S)-2-((S)-1-((R)-2-Amino-2- phenylacetamido)-2-(((R)-2- ((((2R,4S)-4-carboxy-5,5- dimethylthiazolidin-2- yl)methyl)amino)-2-oxo-1- phenylethyl)amino)-2-oxoethyl)- 5,5-dimethylthiazolidine-4- carboxylic Acid; | 25MG,50MG | NA | NA | 672.82 | C31H40N6O7S2 | NA | Ampicillin Trihydrate – In house impurity |
ADI-IMPM-01-00647 | Amsacrine | API | N-(4-(Acridin-9-ylamino)-3- methoxyphenyl)methanesulfona mide; | 25MG,50MG | NA | 51264-14-3 | 393.46 | C21H19N3O3S | NA | Amsacrine – API |
ADI-IMPM-01-00648 | 9-Chloroacridine | Imp B | Acridine, 9-chloro-; | 25MG,50MG | NA | 1207-69-8 | 213.66 | C13H8ClN | NA | Amsacrine – Impurity B |
ADI-IMPM-01-00649 | Acridin-9(10H)-one | Imp C | Acridin-9(10H)-one; | 25MG,50MG | NA | 758-95-0 | 195.22 | C13H9NO | NA | Amsacrine – Impurity C |
ADI-IMPM-01-00650 | Amylmetacresol | API | 6-Pentyl-m-Cresol; 5-Methyl-2- pentylphenol; 6-n-Amyl-m-cresol; | 25MG,50MG | NA | 1300-94-3 | 178.27 | C12H18O | NA | Amylmetacresol – API |
ADI-IMPM-01-00651 | m-Cresol | Imp B | 3-Methylphenol; 1-Hydroxy-3- methylbenzene; 3- Hydroxytoluene; 3-Methylphenol; m-Cresylic acid; mHydroxytoluene; m-Methylphenol | 25MG,50MG | Refrigerator | 108-39-4 | 108.14 | C7H8O | NA | Amylmetacresol – Impurity B |
ADI-IMPM-01-00652 | p-Cresol | Imp D | 4-Methylphenol; 1-Hydroxy-4- methylbenzene; 1-Methyl-4- hydroxybenzene; 4-Cresol; 4- Hydroxytoluene; 4-Methylphenol; | 25MG,50MG | Refrigerator | 106-44-5 | 108.14 | C7H8O | p-Cresylic Acid; pHydroxytoluene; pMethylhydroxybenzene; pMethylphenol; p-Oxytoluene; | Amylmetacresol – Impurity D |
ADI-IMPM-01-00653 | Anagrelide Hydrochloride | API | 6,7-Dichloro-1,5-dihydroimidazo[2,1- b]quinazolin-2(3H)-one; | 25MG,50MG | Freezer | 58579-51-4 | 292.55 | C10H8Cl3N3O | BL-4162A; BMY-26538-01; Agrylin; Tromboreductin; Xagrid; RL 603; | Anagrelide Hydrochloride – API |
ADI-IMPM-01-00654 | Ethyl-2-(6-amino-2,3- dichlorobenzylamino)acetate Hydrochloride | IH | N-[(6-amino-2,3- dichlorophenyl)methyl]glycine Ethyl Ester Hydrochloride | 25MG,50MG | NA | 85325-12-8 | 277.15 | C11H14Cl2N2O2•xHC | Anagrelide Related Impurity A; | Anagrelide Hydrochloride – In house impurity |
ADI-IMPM-01-00655 | (2-Amino-5,6-dichloroquinazolin-3(4H)- yl)acetic Acid | IH | 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid; | 25MG,50MG | Refrigerator | 1159977-03-3 | 274.1 | C10H9Cl2N3O2 | Anagrelide Related Impurity B; | Anagrelide Hydrochloride – In house impurity |
ADI-IMPM-01-00656 | Ethyl 2-(5,6-dichloro-2-imino-1,2- dihydroquinazolin-3(4H)-yl)acetate Hydrobromide | IH | 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Ethyl Ester Hydrobromide; | 25MG,50MG | NA | 70381-75-8 | 383.07 | C12H14BrCl2N3O2 | Anagrelide Related Compound C; | Anagrelide Hydrochloride – In house impurity |
ADI-IMPM-01-00657 | Anagrelide Trichloro Derivatived | IH | 6,7,8-Trichloro-3,5- dihydroimidazo[2,1-b]quinazolin2(1H)-one; 8-Chloro Anagrelide; 6,7,8-Trichloro-1,5- dihydroimidazo[2,1-b]quinazolin | 25MG,50MG | NA | 1092352-99-2 | 290.53 | C10H6Cl3N3O | NA | Anagrelide Hydrochloride – In house impurity |
ADI-IMPM-01-00658 | Anastrozole | API | α1,α1,α3,α3-Tetramethyl-5-(1H-1,2,4- triazol-1-ylmethyl)-1,3- benzenediacetonitrile; | 25MG,50MG | Freezer | 120511-73-1 | 293.37 | C17H19N5 | 2-[3-(2-Cyano-2-propyl)-5-(1,2,4- triazol-1-ylmethyl)phenyl]-2- methylpropiononitrile; Anastrazole; Anastrol; Arimidex; ICI-D 1033; ZD 1033; | Anastrozole – API |
ADI-IMPM-01-00659 | α-Desmethyl Anastrozole | Imp A | 2-[3-(1-Cyanoethyl)-5-(1H,1,2,4-triazole1-ylmethyl)phenyl]-2-methylpropionitrile; | 25MG,50MG | Refrigerator | 1215780-15-6 | 279.34 | C16H17N5 | α1,α1,α3-Trimethyl-5-(1H-1,2,4- triazol-1-ylmethyl)-1,3- benzenediacetonitrile; 2-[3-[(1RS)- 1-cyanoethyl]-5-(1H-1,2,4-triazol-1- ylmethyl)phenyl]-2- methylpropanenitrile; | Anastrozole – Impurity A |
ADI-IMPM-01-00660 | Anastrozole Dimer Impurity | Imp B | 2,3-Bis[3-(1-cyano-1-methylethyl)-5- (1H,1,2,4-triazole-1-ylmethyl)phenyl]-2- methylpropionitrile; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 1216898-82-6 | 279.34 | C16H17N5 | (2RS)-2,3-bis[3-(1-cyano-1- methylethyl)-5-(1H-1,2,4-triazol-1- ylmethyl)phenyl]-2- methylpropanenitrile | Anastrozole – Impurity B |
ADI-IMPM-01-00661 | 2,2′-[5-(Bromomethyl)benzene-1,3- diyl]bis(2-methylpropanenitrile) | Imp C | α,α,α’,α’-Tetramethyl-5-bromomethyl-1,3- benzenediacetonitrile; 5-(Bromomethyl)- α1,α1,α3,α3-tetramethyl-1,3- benzenediacetonitrile; | 25MG,50MG | Refrigerator | 120511-84-4 | 305.21 | C15H17BrN2 | 3,5-Bis(1-cyano-1- methylethyl)benzyl Bromide; 3,5- Bis(2-cyanoprop-2-yl)benzyl Bromide; 2,2’-(5-Bromomethyl)-1,3- phenylene)- bis(methylpropionitrile); | Anastrozole – Impurity C |
ADI-IMPM-01-00662 | 2,2′-[5-(Dibromomethyl)benzene-1,3- diyl]bis(2-methylpropanenitrile) | Imp D | 2,2’-[5-(Dibromomethyl)-1,3-phenylene]- bis(methylpropionitrile); α,α,α’,α’- Tetramethyl-5-(dibromomethyl)-1,3- benzenediacetonitrile; | 25MG,50MG | Freezer | 1027160-12-8 | 384.11 | C15H16Br2N2 | NA | Anastrozole – Impurity D |
ADI-IMPM-01-00663 | 2,2′-[5-(Hydroxymethyl)benzene1,3-diyl]bis(2-methylpropanenitrile) | Imp E | 2,2′-(5-(Hydroxymethyl)-1,3- phenylene)bis(2- methylpropanenitrile); | 25MG,50MG | NA | NA | 242.32 | C15H18N2O | NA | Anastrozole – Impurity E |
ADI-IMPM-01-00664 | 4-Methylbenzenesulfonic Acid | Imp F | p-Toluenesulfonic Acid; | 25MG,50MG | NA | 104-15-4 | 172.2 | C7H8O3S | NA | Anastrozole – Impurity F |
ADI-IMPM-01-00665 | Isoanastrozole | Imp G | 2,2′-[5-(4H-1,2,4-Triazol-4- ylmethyl)benzene-1,3-diyl]bis(2- methylpropanenitrile); | 25MG,50MG | NA | 120511-92-4 | 293.37 | C17H19N5 | α1,α1,α3,α3-Tetramethyl-5-(4H1,2,4-triazol-4-ylmethyl)-1,3- benzenediacetonitrile; | Anastrozole – Impurity G |
ADI-IMPM-01-00666 | 2,2′-(5-Methylbenzene-1,3-diyl)bis(2- methylpropanenitrile) | Imp H | 2,2′-(5-Methyl-1,3-phenylene)bis(2- methylpropanenitrile); α,α,α’,α’- Tetramethyl-5-methyl-1,3- benzenediacetonitrile; α1,α1,α3,α3,5- Pentamethyl-1,3-benzenediacetonitrile; 2,2′-(5-Methyl-1,3-phenylene) di(2- methylpropionitrile) | 25MG,50MG | Refrigerator | 120511-72-0 | 226.32 | C15H18N2 | 2-[3-(Cyanodimethylmethyl)-5- methylphenyl] -2- methylpropionitrile; 3,5-Bis(2- cyano-2-methylethyl)toluene; 3,5- Bis(2-cyanoprop-2-yl)toluene; Anastrozole Related Compound A; | Anastrozole – Impurity H |
ADI-IMPM-01-00667 | 2,2′-[5-(Chloromethyl)benzene-1,3- diyl]bis(2-methylpropanenitrile) | Imp I | 2,2′-(5-(Chloromethyl)-1,3- phenylene)bis(2- methylpropanenitrile); | 25MG,50MG | NA | NA | 260.76 | C15H17ClN2 | NA | Anastrozole – Impurity I |
ADI-IMPM-01-00668 | Anastrozole Diamide Impurity | IH | 2,2′-(5-((1H-1,2,4-Triazol-1-yl)methyl)- 1,3-phenylene)bis(2- methylpropanamide); | 25MG,50MG | NA | 120512-04-1 | 329.4 | C17H23N5O2 | NA | Anastrozole – In house impurity |
ADI-IMPM-01-00669 | Anastrozole Diacid | IH | 2,2′-(5-((1H-1,2,4-Triazol-1-yl)methyl)- 1,3-phenylene)bis(2-methylpropanoic Acid); | 25MG,50MG | NA | 1338800-81-9 | 331.37 | C17H21N3O4 | NA | Anastrozole – In house impurity |
ADI-IMPM-01-00670 | Androstanolone | API | (5α,17β)-17-Hydroxyandrostan-3-one; Dihydrotestosterone; 5αDihydrotestosterone; Stanolone; | 25MG,50MG | Refrigerator | 521-18-6 | 290.44 | C19H30O2 | 5α-Androstan-17β-ol-3-one; 17βHydroxy-5α-androstan-3-one; 4,5αDihydrotestosterone | Androstanolone – API |
ADI-IMPM-01-00671 | Androstenone | IH | 5α-Androstenone; (5α)-Androst-16-en-3- one; 16,(5α)-Androsten-3-one; | 25MG,50MG | Refrigerator | 18339-16-7 | 272.43 | C19H28O | 5α-Androst-16-ene-3-one; E 282 | Anastrozole – In house impurity |
ADI-IMPM-01-00672 | Androsterone | API | 3α-Hydroxy-5α-androstan-17- one; 5α-Androstan-3α-ol-17-one; | 25MG,50MG | NA | 53-41-8 | 290.44 | C19H30O2 | (3R,5S,8R,9S,10S,13S,14S)- 3-hydroxy-10,13-dimethyl1,2,3,4,5,6,7,8,9,11,12,14,1 5,16- tetradecahydrocyclopenta[a] | Androstanolone – API |
ADI-IMPM-01-00673 | (5α,16β)-N-Acetyl-16-[2- (acetyloxy)acetyloxy)-2’H-androst2-eno[3,2-c]pyrazol-17-one | IH | (5α,16β)-N-Acetyl-16-[2- (acetyloxy)acetyloxy)-2’H-androst2-eno[3,2-c]pyrazol-17-one; | 25MG,50MG | Refrigerator | NA | 470.56 | C26H34N2O6 | NA | Anastrozole – In house impurity |
ADI-IMPM-01-00674 | (5α,16β)-N-Acetyl-16-acetyloxy2’H-androst-2-eno[3,2-c]pyrazol-17- one | IH | (5α,16β)-N-Acetyl-16-acetyloxy2’H-androst-2-eno[3,2-c]pyrazol17-one; | 25MG,50MG | Refrigerator | NA | 412.52 | C24H32N2O4 | NA | Anastrozole – In house impurity |
ADI-IMPM-01-00675 | 5α-N-Acetyl-2’H-androst-2-eno[3,2- c]pyrazol-17-one | IH | 5a-N-Acetyl-2’H-androst-2- eno[3,2-c]pyrazol-17-one; | 25MG,50MG | Refrigerator | NA | 339.45 | C21H27N2O2 | NA | Anastrozole – In house impurity |
ADI-IMPM-01-00676 | 0 5α-N-Acetyl-2’H-androst-16-en-2- eno[3,2-c]pyrazol-17-ol Acetate | IH | 5α-N-Acetyl-17-acetyloxy-2’Handrost-16-en-2-eno[3,2- c]pyrazol; | 25MG,50MG | Refrigerator | NA | 390.52 | C24H32N2O3 | NA | Anastrozole – In house impurity |
ADI-IMPM-01-00677 | Anidulafungin | API | 1-[(4R,5R)-4,5-Dihydroxy-N2-[[4”- (pentyloxy)[1,1′:4′,1”-terphenyl]-4- yl]carbonyl]-L-ornithine]echinocandin B; Ecalta; Eraxis; LY 303366; | 25MG,50MG | NA | 166663-25-8 | 1140.24 | C58H73N7O17 | NA | Anidulafungin – API |
ADI-IMPM-01-00678 | Echinocandin B | IH | Ecb;Nsc287461;Aids008606;Aids008606;Antibiotic A 22082 | 25MG,50MG | NA | 54651-05-7 | 1060.24 | C52H81N7O16 | Antibiotic sl 7810f;Antibiotic A 30912a;Cyclo[L-Thr- [(3S,4S)-3-hydroxy-4-methylL-Pro-]-[(4R,5R)-4,5- dihydroxy-N2-[(9Z,12Z)-1- oxo-9,12-octadecadien-1-yl]- L-Orn*-]-L-Thr-L-t4Hyp- [(3S,4S)-3,4-dihydroxy-4-(4- hydroxyphenyl)-L-Abu-]] | Anastrozole – In house impurity |
ADI-IMPM-01-00679 | Antazoline Hydrochloride | API | 4,5-Dihydro-N-phenyl-N-(phenylmethyl)- 1H-Imidazole-2-methanamine Hydrochloride 4,5-Dihydro-N-phenyl-N- (phenylmethyl)-1H-Imidazole-2- methanamine Monohydrochloride; | 25MG,50MG | NA | 2508-72-7 | 301.81 | C17H20ClN3 | 2-[(N-Benzylanilino)methyl]-2- imidazoline Monohydrochloride; 2- (N-Benzylanilinomethyl)-2- imidazoline Hydrochloride; 5512M; Antastan; Antasten; Antazoline chloride; Antazoline hydrochloride; Antihistal; Antistin; Antistina; Antistine hydrochloride; Azalone; Ben-a-hist; Dibistin; Fenazolina; Histazine; Histostab; Imidamine; Phenazoline Hydrochloride; |
Antazoline Hydrochloride – API |
ADI-IMPM-01-00680 | N-Benzylaniline | IH | Benzylphenylamine; N-Benzyl-Nphenylamine; | 25MG,50MG | NA | 103-32-2 | 183.25 | C13H13N | Benzylaniline; NBenzylbenzenamine; NBenzylphenylamine; N-Phenyl-Nbenzylamine; NPhenylbenzenemethanamine; NSC 147284; Phenylbenzylamin | Anastrozole – In house impurity |
ADI-IMPM-01-00681 | 2-Chloromethyl-4,5-dihydro-1H-imidazole Hydrochloride | IH | 2-Chloromethyl-4,5-dihydro-1Himidazole Hydrochloride; | 25MG,50MG | NA | 13338-49-3 | 155.03 | C4H8Cl2N2 | NA | Anastrozole – In house impurity |
ADI-IMPM-01-00682 | Antazoline Methansulfonate | IH | Antazoline Methanesulfonate; 2- ((Benzyl(phenyl)amino)methyl)- 4,5-dihydro-1H-imidazol-1-ium Methanesulfonate; | 25MG,50MG | NA | 3131-32-6 | 361.46 | C18H23N3O3S | NA | Anastrozole – In house impurity |
ADI-IMPM-01-00683 | Antazoline Phosphate | API | Antistine Phosphate; 2-[(NBenzylanilino)methyl]-2-imidazoline Phosphate; | 25MG,50MG | Refrigerator | 154-68-7 | 363.35 | C17H22N3O4P | 4,5-Dihydro-N-phenyl-N- (phenylmethyl)-1H-imidazole-2- methanamine Phosphate; | Antazoline Phosphate – API |
ADI-IMPM-01-00684 | Antipyrine | API | 1,2-Dihydro-1,5-dimethyl-2-phenyl-3Hpyrazol-3-one; 2-Trideuteromethyl-3- methyl-1-phenyl-3-pyrazolin-5-one; | 25MG,50MG | Refrigerator | 60-80-0 | 188.23 | C11H12N2O | Analgesine; Anodynine; Sedatine; Parodyne; Phenazon; Phenazone; | Antipyrine – API |
ADI-IMPM-01-00685 | 4-Methylamino Antipyrine | IH | 1,2-Dihydro-1,5-dimethyl-4- (methylamino)-2-phenyl-3H-pyrazol-3- one; 4-Methylaminophenazone; | 25MG,50MG | Freezer | 519-98-2 | 217.27 | C12H15N3O | 4-Monomethylaminoantipyrine; NMethyl-4-aminoantipyrine; Noramidopyrine; Noraminopyrine; | Antipyrine – In house impurity |
ADI-IMPM-01-00686 | Apigenin | API | 5,7-Dihydroxy-2-(4-hydroxyphenyl)-4H-1- benzopyran-4-one; 4′,5,7- Trihydroxyflavone; Pelargidenon 1449; | 25MG,50MG | Freezer | 520-36-5 | 270.24 | C15H10O5 | NA | Apigenin – API |
ADI-IMPM-01-00687 | Apigenin 7-glucoside | Imp B | Apigetrin; Cosmosiin; | 25MG,50MG | NA | 578-74-5 | 432.38 | C21H20O10 | NA | Apigenin – Impurity B |
ADI-IMPM-01-00688 | Apixaban | API | 4,5,6,7-Tetrahydro-1-(4-methoxyphenyl)- 7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]- 1H-pyrazolo[3,4-c]pyridine-3- carboxamide; | 25MG,50MG | Refrigerator | 503612-47-3 | 459.5 | C25H25N5O4 | BMS 562247-01; 1-(4- Methoxyphenyl)-7-oxo-6-[4-(2- oxopiperidin-1-yl)phenyl]-4,5,6,7- tetrahydro-1H-pyrazolo[3,4- c]pyridine-3-carboxylic Acid Amide; | Apixaban – API |
ADI-IMPM-01-00689 | O-Desmethyl Apixaban | IH | 4-Demethoxy-4-hydroxy Apixaban; 4,5,6,7-Tetrahydro-1-(4-hydroxyphenyl)- 7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]- 1H-pyrazolo[3,4-c]pyridine-3- carboxamide; | 25MG,50MG | NA | 503612-76-8 | 445.47 | C24H23N5O4 | 1-(4-Hydroxyphenyl)-7-oxo-6-[4-(2- oxopiperidin-1-yl)phenyl]-4,5,6,7- tetrahydro-1H-pyrazolo[3,4- c]pyridine-3-carboxamide; | Apixaban – In house impurity |
ADI-IMPM-01-00690 | O-Desmethyl Apixaban Sulfate | IH | 4-(3-Carbamoyl-7-oxo-6-(4-(2- oxopiperidin-1-yl)phenyl)-4,5,6,7- tetrahydro-1H-pyrazolo[3,4-c]pyridin-1- yl)phenyl hydrogen Sulfate; |
25MG,50MG | NA | NA | 525.53 | C24H23N5O7S | NA | Apixaban – In house impurity |
ADI-IMPM-01-00691 | Hydroxy Apixaban | IH | 6-(4-(3-Hydroxy-2-oxopiperidin-1- yl)phenyl)-1-(4-methoxyphenyl)-7-oxo4,5,6,7-tetrahydro-1H-pyrazolo[3,4- c]pyridine-3-carboxamide; | 25MG,50MG | NA | NA | 475.5 | C25H25N5O5 | NA | Apixaban – In house impurity |
ADI-IMPM-01-00692 | Hydroxy O-Demethyl Apixaban | IH | 6-(4-(3-Hydroxy-2-oxopiperidin-1- yl)phenyl)-1-(4-hydroxyphenyl)-7-oxo4,5,6,7-tetrahydro-1H-pyrazolo[3,4- c]pyridine-3-carboxamide | 25MG,50MG | NA | NA | 461.47 | C24H23N5O5 | NA | Apixaban – In house impurity |
ADI-IMPM-01-00693 | Hydroxy O-Demethyl Apixaban Sulfate | IH | 4-(3-Carbamoyl-6-(4-(3-hydroxy-2- oxopiperidin-1-yl)phenyl)-7-oxo-4,5,6,7- tetrahydro-1H-pyrazolo[3,4-c]pyridin-1- yl)phenyl Hydrogen Sulfate; | 25MG,50MG | NA | NA | 541.53 | C24H23N5O8S | NA | Apixaban – In house impurity |
ADI-IMPM-01-00694 | 3-Carbamoyl-1-(4-methoxyphenyl)- 4-(2-(4-(2-oxopiperidin-1- yl)phenylamino)ethyl)-1H-pyrazole5-carboxylic Acid | IH | 3-Carbamoyl-1-(4- methoxyphenyl)-4-(2-((4-(2- oxopiperidin-1- yl)phenyl)amino)ethyl)-1Hpyrazole-5-carboxylic Acid; | 25MG,50MG | NA | NA | 477.51 | C25H27N5O5 | NA | Apixaban – In house impurity |
ADI-IMPM-01-00695 | Apixaban Carboxylic Acid Impurity | IH | Apixaban Acid; 1-(4-Methoxyphenyl)-7- oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]- 4,5,6,7-tetrahydro-1H-pyrazolo[3,4- c]pyridine-3-carboxylic Acid; | 25MG,50MG | NA | 503614-92-4 | 460.48 | C25H24N4O5 | 4,5,6,7-Tetrahydro-1-(4- methoxyphenyl)-7-oxo-6-[4-(2-oxo1-piperidinyl) phenyl]-1Hpyrazolo[3,4-c]pyridine-3- carboxylic Acid; | Apixaban – In house impurity |
ADI-IMPM-01-00696 | 6-(4-Aminophenyl)-1-(4- methoxyphenyl)-7-oxo-4,5,6,7- tetrahydro-1H-pyrazolo[3,4- c]pyridine-3-carboxylic Acid | IH | 6-(4-Aminophenyl)-1-(4- methoxyphenyl)-7-oxo-4,5,6,7- tetrahydro-1H-pyrazolo[3,4- c]pyridine-3-carboxylic Acid; | 25MG,50MG | NA | NA | 378.38 | C20H18N4O4 | NA | Apixaban – In house impurity |
ADI-IMPM-01-00697 | Apixaban Amino Acid Impurity | IH | 5-((4-(3-Carbamoyl-1-(4-methoxyphenyl)- 7-oxo-4,5-dihydro-1H-pyrazolo[3,4- c]pyridin-6(7H)- yl)phenyl)amino)pentanoic Acid; | 25MG,50MG | NA | NA | 477.51 | C25H27N5O5 | Apixaban Metabolite 5; Valeric Lactam Ring-opened Apixaban; | Apixaban – In house impurity |
ADI-IMPM-01-00698 | Methyl 6-(4-Aminophenyl)-1-(4- methoxyphenyl)-7-oxo-4,5,6,7- tetrahydro-1H-pyrazolo[3,4- c]pyridine-3-carboxylate | IH | Methyl 6-(4-Aminophenyl)-1-(4- methoxyphenyl)-7-oxo-4,5,6,7- tetrahydro-1H-pyrazolo[3,4- c]pyridine-3-carboxylate; |
25MG,50MG | NA | NA | 392.41 | C21H20N4O4 | NA | Apixaban – In house impurity |
ADI-IMPM-01-00699 | Apixaban Methyl Ester Impurity | IH | 4,5,6,7-Tetrahydro-1-(4-methoxyphenyl)- 7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]- 1H-Pyrazolo[3,4-c]pyridine-3-carboxylic Acid Methyl Ester; Apixaban Acid Methyl Ester; | 25MG,50MG | NA | 1074365-84-6 | 474.51 | C26H26N4O5 | Methyl 1-(4-methoxyphenyl)-7-oxo6-(4-(2-oxopiperidin-1-yl)phenyl)- 4,5,6,7-tetrahydro-1H-pyrazolo[3,4- c]pyridine-3-carboxylate; | Apixaban – In house impurity |
ADI-IMPM-01-00700 | Methyl 5-((4-(3-Carbamoyl-1-(4- methoxyphenyl)-7-oxo-4,5-dihydro1H-pyrazolo[3,4-c]pyridin-6(7H)- yl)phenyl)amino)pentanoate | IH | Methyl 5-((4-(3-Carbamoyl-1-(4- methoxyphenyl)-7-oxo-4,5- dihydro-1H-pyrazolo[3,4-c]pyridin6(7H)- yl)phenyl)amino)pentanoate; | 25MG,50MG | NA | NA | 491.54 | C26H29N5O5 | NA | Apixaban – In house impurity |
ADI-IMPM-01-00701 | Apixaban Dehydro Impurity | IH | Apixaban 4,5-Dehydro Impurity; 4,5-Dehydro Apixaban; 6,7- Dihydro-1-(4-methoxyphenyl)-7- oxo-6-[4-(2-oxo-1- piperidinyl)phenyl]-1HPyrazolo[3,4-c]pyridine-3- carboxamide; | 25MG,50MG | Refrigerator | 1074549-89-5 | 457.48 | C25H23N5O4 | 1-(4-Methoxyphenyl)-7-oxo6-(4-(2-oxopiperidin-1- yl)phenyl)-6,7-dihydro-1Hpyrazolo[3,4-c]pyridine-3- carboxamide; | Apixaban – In house impurity |
ADI-IMPM-01-00702 | Apomorphine Hydrochloride Hemihydrate | API | (6aR)-5,6,6a,7-Tetrahydro-6-methyl-4Hdibenzo[de,g]quinoline-10,11-diol Hydrochloride Hemihydrate; | 25MG,50MG | Hygroscopic , Refrigerator, Under inert atmosphere | 41372-20-7 | 312.79 | C17H18ClNO2 • 1/2 H2 | 6aβ-Aporphine-10,11-diol Hydrochloride Hemihydrate; (-)- 10,11-Dihydroxy-aporphine Hydrochloride Hemihydrate; Apokyn Hemihydrate; Apomorphin Hemihydrate; Apomorphine Hemihydrate; Ixense Hemihydra | Apomorphine Hydrochloride Hemihydrate – API |
ADI-IMPM-01-00703 | Apremilast | API | (S)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2- methylsulfonylethyl]-4- acetylaminoisoindoline-1,3-dione; | 25MG,50MG | Refrigerator | 608141-41-9 | 460.5 | C22H24N2O7S | (S)-N-(2-(1-(3-Ethoxy-4- methoxyphenyl)-2- (methylsulfonyl)ethyl)-1,3- dioxoisoindolin-4-yl)acetamide; Apremilast; CC 10004; | Apremilast – API |
ADI-IMPM-01-00704 | Aprepitant | API | 5-[[(2R,3S)-2-[(1R)-1-[3,5- Bis(trifluoromethyl)phenyl]ethoxy]-3-(4- fluorophenyl)-4-morpholinyl]methyl]-1,2- dihydro-3H-1,2,4-triazol-3-one; | 25MG,50MG | Freezer | 170729-80-3 | 534.43 | C23H21F7N4O3 | Emend; L 754030; MK 0869; MK 869; ONO 7436; | Apremilast – API |
ADI-IMPM-01-00705 | Defluoro Aprepitant | Imp A | 5-[[(2R,3S)-2-[(1R)-1-[3,5- Bis(trifluoromethyl)phenyl]ethoxy]- 3-phenyl-4-morpholinyl]methyl]- 1,2-dihydro-3H-1,2,4-triazol-3- one; 5-(((2R,3S)-2-((R)-1-(3,5- bis(trifluoromethyl)phenyl)ethoxy)- 3-phenylmorpholino)methyl)-1H | 25MG,50MG | NA | 170729-76-7 | 516.44 | C23H22F6N4O3 | NA | Aprepitant – Impurity A |
ADI-IMPM-01-00706 | 4-Defluoro-3-(p-fluorophenyl) Aprepitant | Imp B | Aprepitant meta-Biphenyl Impurity; 3-(((2R,3S)-2-((R)-1-(3,5- Bis(trifluoromethyl)phenyl)ethoxy)- 3-(4’-fluoro-[1,1’-biphenyl]-3- yl)morpholino)methyl)-1H-1,2,4- triazol-5(4H)-one; | 25MG,50MG | NA | NA | 610.52 | C29H25F7N4O3 | 5-(((2S,3R)-2-((R)-1-(3,5- Bis(trifluoromethyl)phenyl)et hoxy)-3-(4′-fluoro-[1,1′- biphenyl]-3- yl)morpholino)methyl)-1H1,2,4-triazol-3(2H)-one; 5- [[(2R,3S)-2-[(1R)-1-[3,5- bis(trifluoromethyl)phenyl]et | Aprepitant – Impurity B |
ADI-IMPM-01-00707 | 4-Defluoro-4-(pfluorophenyl)aprepitant | Imp C | Aprepitant para-Biphenyl Impurity; 3-(((2R,3S)-2-((R)-1-(3,5- Bis(trifluoromethyl)phenyl)ethoxy)- 3-(4’-fluoro-[1,1’-biphenyl]-4- yl)morpholino)methyl)-1H-1,2,4- triazol-5(4H)-one; | 25MG,50MG | NA | NA | 610.52 | C29H25F7N4O3 | 5-(((2R,3S)-2-((R)-1-(3,5- Bis(trifluoromethyl)phenyl)et hoxy)-3-(4′-fluoro-[1,1′- biphenyl]-4- yl)morpholino)methyl)-1H1,2,4-triazol-3(2H)-one; | Aprepitant – Impurity C |
ADI-IMPM-01-00708 | Aprepitant N-Oxide | IH | [2R-[2α(R*),3α]]-5-[[2-[1-[3,5- Bis(trifluoromethyl)phenyl]ethoxy]-3-(4- fluorophenyl)-4-oxido-4- morpholinyl]methyl]-1,2-dihydro-3H-1,2,4- triazol-3-one | 25MG,50MG | NA | 172673-23-3 | 550.43 | C23H21F7N4O4 | NA | Aprepitant – In house impurity |
ADI-IMPM-01-00709 | (R,R,R)-Aprepitant | IH | 5-[[(2R,3R)-2-[(1R)-1-[3,5- Bis(trifluoromethyl)phenyl]ethoxy]- 3-(4-fluorophenyl)-4- morpholinyl]methyl]-1,2-dihydro3H-1,2,4-triazol-3-one; 3- (((2R,3R)-2-((R)-1-(3,5- Bis(trifluoromethyl)phenyl)ethoxy | 25MG,50MG | NA | 1148113-53-4 | 534.43 | C23H21F7N4O3 | Aprepitant Related Compound A; | Aprepitant – In house impurity |
ADI-IMPM-01-00710 | (1R,2S,3S)-Aprepitant | IH | (2S,3S,1’R)-Aprepitant; 3- (((2S,3S)-2-((R)-1-(3,5- Bis(trifluoromethyl)phenyl)ethoxy)- 3-(4- fluorophenyl)morpholino)methyl)- 1H-1,2,4-triazol-5(4H)-one; 5- (((2S,3S)-2-((R)-1-(3,5- Bis(trifluoromethyl)phenyl)ethoxy) | 25MG,50MG | NA | 172822-28-5 | 534.43 | C23H21F7N4O3 | [2S-[2α(S*),3β]]-5-[[2-[1-[3,5- Bis(trifluoromethyl)phenyl]et hoxy]-3-(4-fluorophenyl)-4- morpholinyl]methyl]-1,2- dihydro-3H-1,2,4-triazol-3- one; | Aprepitant – In house impurity |
ADI-IMPM-01-00711 | (1S,2R,3S)-Aprepitant | IH | [1(S)-Phenylethoxy]-Aprepitant; 3- (((2R,3S)-2-((S)-1-(3,5- Bis(trifluoromethyl)phenyl)ethoxy)- 3-(4- fluorophenyl)morpholino)methyl)- 1H-1,2,4-triazol-5(4H)-one; | 25MG,50MG | NA | 170902-81-5 | 534.43 | C23H21F7N4O3 | [2S-[2α(S*),3β]]-5-[[2-[1-[3,5- Bis(trifluoromethyl)phenyl]et hoxy]-3-(4-fluorophenyl)-4- morpholinyl]methyl]-1,2- dihydro-3H-1,2,4-triazol-3- one; | Aprepitant – In house impurity |
ADI-IMPM-01-00712 | ent-Aprepitant | IH | (1S,2S,3R-Aprepitant; 5-[[(2S,3R)- 2-[(1S)-1-[3,5- Bis(trifluoromethyl)phenyl]ethoxy]- 3-(4-fluorophenyl)-4- morpholinyl]methyl]-1,2-dihydro3H-1,2,4-triazol-3-one; 3- [[(2S,3R)-2-[(S)-1-[3,5- Bis(trifluoromethyl)phenyl]ethoxy] | 25MG,50MG | NA | 172822-29-6 | 534.43 | C23H21F7N4O3 | [2S-[2α(S*),3β]]-5-[[2-[1-[3,5- Bis(trifluoromethyl)phenyl]et hoxy]-3-(4-fluorophenyl)-4- morpholinyl]methyl]-1,2- dihydro-3H-1,2,4-triazol-3- one; | Aprepitant – In house impurity |
ADI-IMPM-01-00713 | (1R,2S,3R)-Aprepitant | IH | Aprepitant (R,S,R)-Isomer; (2S,3R,1’R)-Aprepitant; 5- [[(2S,3R)-2-[(1R)-1-[3,5- Bis(trifluoromethyl)phenyl]ethoxy]- 3-(4-fluorophenyl)-4- morpholinyl]methyl]-1,2-dihydro3H-1,2,4-triazol-3-one | 25MG,50MG | NA | 1185502-97-9 | 534.43 | C23H21F7N4O3 | [2S-[2α(S*),3β]]-5-[[2-[1-[3,5- Bis(trifluoromethyl)phenyl]et hoxy]-3-(4-fluorophenyl)-4- morpholinyl]methyl]-1,2- dihydro-3H-1,2,4-triazol-3- one; | Aprepitant – In house impurity |
ADI-IMPM-01-00714 | (1S,2R,3R)-Aprepitant | IH | Aprepitant (S,R,R)-Isomer; (2R,3R,1’S)-Aprepitant; 5- [[(2R,3R)-2-[(1S)-1-[3,5- Bis(trifluoromethyl)phenyl]ethoxy]- 3-(4-fluorophenyl)-4- morpholinyl]methyl]-1,2-dihydro3H-1,2,4-triazol-3-one; | 25MG,50MG | NA | 1242175-34-3 | 534.43 | C23H21F7N4O3 | [2S-[2α(S*),3β]]-5-[[2-[1-[3,5- Bis(trifluoromethyl)phenyl]et hoxy]-3-(4-fluorophenyl)-4- morpholinyl]methyl]-1,2- dihydro-3H-1,2,4-triazol-3- one; | Aprepitant – In house impurity |
ADI-IMPM-01-00715 | (1S,2S,3S)-Aprepitant | IH | (S,S,S)-Aprepitant; 5-[[(2S,3S)-2- [(1S)-1-[3,5- Bis(trifluoromethyl)phenyl]ethoxy]- 3-(4-fluorophenyl)-4- morpholinyl]methyl]-1,2-dihydro3H-1,2,4-triazol-3-one; | 25MG,50MG | NA | 1242175-40-1 | 534.43 | C23H21F7N4O3 | NA | Aprepitant – In house impurity |
ADI-IMPM-01-00716 | Aprepitant M2 Metabolite (1R,2R,3S)-Isomer | IH | (2R,2-α-R,3a)-2-[1-[3,5- Bis(trifluoromethyl)phenyl]ethoxy]- 3-(4-fluorophenyl)-1,4-oxazine; (2R,3S)-2-[(1R)-1-[3,5- Bis(trifluoromethyl)phenyl)ethoxy]- 3-(4-fluorophenyl)morpholine; Aprepitant M2 Metabolite; | 25MG,50MG | Freezer | r 171338-27-5 | 437.35 | C20H18F7NO2 | (2R)-[1-(R)-(3,5- Bis(trifluoromethyl)phenyl)et hoxy]-3-(4-fluorophenyl)- (3S)-morpholine; 2-(R)-[1- (R)-(3,5- Bis(trifluoromethyl)phenyl)et hoxy]-3-(S)- | Aprepitant – In house impurity |
ADI-IMPM-01-00717 | N-(Destriazolonomethyl) N- (Methylcarboxyacetamidohydrazon o) Aprepitant | IH | Methyl 2-(2-((2R,3S)-2-((R)-1-(3,5- Bis(trifluoromethyl)phenyl)ethoxy)- 3-(4-fluorophenyl)morpholino)-1- iminoethyl)hydrazinecarboxylate; | 25MG,50MG | NA | 219821-37-1 | 566.47 | C24H25F7N4O4 | NA | Aprepitant – In house impurity |
ADI-IMPM-01-00718 | Aprindine Hydrochloride | API | N1-(2,3-Dihydro-1H-inden-2-yl)-N3,N3- diethyl-N1-phenyl-1,3-propanediamine Hydrochloride; | 25MG,50MG | NA | 33237-74-0 | 358.95 | C22H31ClN2 | N-(2,3-Dihydro-1H-inden-2-yl)- N’,N’-diethyl-N-phenyl-1,3- propanediamine; Amidonal; Aspenon; Compd 83846; Fibocil; Fiboran; MS 5075; NSC 284614; Ritmusin; | Aprindine Hydrochloride – API |
ADI-IMPM-01-00719 | Arachidonic Acid | API | (5Z,8Z,11Z,14Z)-5,8,11,14- Eicosatetraenoic Acid; | 25MG,50MG | Freezer | 506-32-1 | 304.47 | C20H32O2 | (all-Z)-5,8,11,14-Eicosatetraenoic Acid; 5,8,11,14-all-cisEicosatetraenoicmmunocytophyte; Immunocytophyte; all-cis-5,8,11,14- Eicosatetraenoic Acid; cis5,8,11,14-Eicosatetraenoic Acid | Aprindine Hydrochloride – API |
ADI-IMPM-01-00720 | 12(S)-Hydroxy (5Z,8Z,10E,14Z)- Eicosatetraenoic Acid | IH | [S-(E,Z,Z,Z)]-12-Hydroxy-5,8,10,14- eicosatetraenoic Acid; | 25MG,50MG | NA | 54397-83-0 | 320.47 | C20H32O3 | 12-HETE; 12-Hydroxy-5,8,10,14- eicosatetraenoic Acid; 12- Hydroxyeicosatetraenoic Acid; 12- L-Hydroxy-5,8,10,14- eicosatetraenoic Acid; | Arachidonic Acid – In house impurity |
ADI-IMPM-01-00721 | Arachidonic Acid Glycidyl Ester | IH | Glycidyl Arachidonate; (5Z,8Z,11Z,14Z)- 5,8,11,14-Eicosatetraenoic Acid Oxiranylmethyl Ester; | 25MG,50MG | Amber Vial, Freezer |
439146-24-4 | 360.53 | C23H36O3 | Arachidonoyl-glycidyl Ester; | Arachidonic Acid – In house impurity |
ADI-IMPM-01-00722 | Ethyl Arachidonate | IH | (5Z,8Z,11Z,14Z)-5,8,11,14- Eicosatetraenoic Acid Ethyl Ester; | 25MG,50MG | NA | 1808-26-0 | 332.52 | C22H36O2 | (all-Z)-5,8,11,14-Eicosatetraenoic Acid Ethyl Ester; Arachidonic Acid Ethyl Ester; | Arachidonic Acid – In house impurity |
ADI-IMPM-01-00723 | Arecoline Hydrobromide | API | 1,2,5,6-Tetrahydro-1-methyl-3- pyridinecarboxylic Acid Methyl Ester Hydrobromide; | 25MG,50MG | Refrigerator | 300-08-3 | 236.11 | C8H14BrNO2 | 1-Methyl-1,2,5,6-tetrahydropyridine-3-carboxylic Acid Methyl Ester Hydrobromide; Arecaidine Methyl Ester Hydrobromide; Arecolin Hydrobromide; Methylarecaidine Hydrobromide; | Arecoline Hydrobromide – API |
ADI-IMPM-01-00724 | Arecaidine Ethyl Ester Hydrochloride | IH | 1,2,5,6-Tetrahydro-1-methyl-3- pyridinecarboxylic Acid Ethyl Ester Hydrochloride; | 25MG,50MG | NA | 17210-50-3 | 205.68 | C9H16ClNO2 | 1,2,5,6-Tetrahydro-1- methylnicotinic Acid Ethyl Ester Hydrochloride; | Arecoline Hydrobromide – In house impurity |
ADI-IMPM-01-00725 | Argatroban | API | (2R,4R)1-[(2S)2-Amino-5- [[imino(nitroamino)methyl]amino]-1- oxopentyl]-4-methyl-2- piperidinecarboxylic Acid Ethyl Ester Hydrochloride; Argatroban Intermediate; | 25MG,50MG | Hygroscopic, Freezer, Under inert atmosphere | 74874-08-1 | 408.88 | C15H29ClN6O5 | NA | Argatroban – API |
ADI-IMPM-01-00726 | (2S,4S)-1-[(2S)-2-Amino-5- [[imino(nitroamino)methyl]amino]-1- oxopentyl]-4-methyl-2-piperidinecarboxylic Acid Benzyl Ester Hydrochloride | IH | (2S,4S)-1-[(2S)-2-Amino-5- [[imino(nitroamino)methyl]amino]-1- oxopentyl]-4-methyl-2- piperidinecarboxylic Acid Benzyl Ester Hydrochloride | 25MG,50MG | Hygroscopic, Freezer, Under inert atmosphere | NA | 470.95 | C20H31ClN6O5 | NA | Argatroban – In house impurity |
ADI-IMPM-01-00727 | (2R,4R)-rel-N-tert-Butyloxycarbonyl-4- methyl-2-piperidinecarboxylic Acid Benzyl Ester | IH | (2R,4R)-rel-4-Methyl-1,2- piperidinedicarboxylic Acid 1-(1,1- Dimethylethyl) 2-(Phenylmethyl) Ester; | 25MG,50MG | NA | 339183-92-5 | 333.42 | C19H27NO4 | NA | Argatroban – In house impurity |
ADI-IMPM-01-00728 | 2S,4S)-1-[(2S)-2-[(tertButyloxycarbonyl)amino]-5- [[imino(nitroamino)methyl]amino]-1- oxopentyl]-4-methyl-2-piperidinecarboxylic Acid Benzyl Este | IH | (2S,4S)-1-[(2S)-2-[[(1,1- Dimethylethoxy)carbonyl]amino]-5- [[imino(nitroamino)methyl]amino]-1- oxopentyl]-4-methyl-2- piperidinecarboxylic Acid Phenylmethyl Ester; | 25MG,50MG | Hygroscopic, Freezer, Under inert atmosphere | NA | 534.61 | C25H38N6O7 | NA | Argatroban – In house impurity |
ADI-IMPM-01-00729 | (2R,4R)-1-[(2S)-2-[(tertButyloxycarbonyl)amino]-5- [[imino(nitroamino)methyl]amino]-1- oxopentyl]-4-methyl-2-piperidinecarboxylic Acid Benzyl Ester | IH | (2R,4R)-1-[(2S)-2-[[(1,1- Dimethylethoxy)carbonyl]amino]-5- [[imino(nitroamino)methyl]amino]-1- oxopentyl]-4-methyl-2- piperidinecarboxylic Acid Phenylmethyl Ester; | 25MG,50MG | Hygroscopic, Freezer, Under inert atmosphere | 367952-82-7 | 171.24 | C25H38N6O7 | NA | Argatroban – In house impurity |
ADI-IMPM-01-00730 | Ethyl (2R,4R)-4-Methylpipecolate | IH | (2R-trans)-4-Methyl-2- piperidinecarboxylic Acid Ethyl Ester; | 25MG,50MG | NA | 74892-82-3 | 171.24 | C9H17NO2 | Ethyl (2R,4R)-4-Methyl-2- piperidinecarboxylate; (2R,4R)-4- Methyl-2-piperidinecarboxylic Acid Ethyl Ester; | Argatroban – In house impurity |
ADI-IMPM-01-00731 | Ethyl (2R,4S)-4-Methylpipecolate | IH | (2R,4S)-4-Methyl-2-piperidinecarboxylic Acid Ethyl Ester; (2R-cis)-4-Methyl-2- piperidinecarboxylic Acid Ethyl Ester; | 25MG,50MG | NA | 79199-61-4 | 171.24 | C9H17NO2 | NA | Argatroban – In house impurity |
ADI-IMPM-01-00732 | Ethyl (2S,4R)-4-Methylpipecolate | IH | (2S,4R)-4-Methyl-2-piperidinecarboxylic Acid Ethyl Ester; (2S-cis)-4-Methyl-2- piperidinecarboxylic Acid Ethyl Ester; | 25MG,50MG | NA | 79199-62-5 | 171.24 | C9H17NO2 | NA | Argatroban – In house impurity |
ADI-IMPM-01-00733 | Ethyl (2S,4S)-4-Methylpipecolate | IH | (2S,4S)-4-Methyl-2-piperidinecarboxylic Acid Ethyl Ester; (2S-trans)-4-Methyl-2- piperidinecarboxylic Acid Ethyl Ester; | 25MG,50MG | NA | 78306-52-2 | 171.24 | C9H17NO2 | NA | Argatroban – In house impurity |
ADI-IMPM-01-00734 | N-Nitro-1,2,3,4-tetradehydro Argatroban | IH | (2R,4R)-1-[(2S)-5- [[Imino(nitroamino)methyl]amino]-2-[[(3- methyl-8-quinolinyl)sulfonyl]amino]-1- oxopentyl]-4-methyl-2- piperidinecarboxylic Acid; | 25MG,50MG | Amber Vial, Freezer | 74874-10-5 | 549.6 | C9H17NO2 | [2R-[1(S*),2α,4β]]-1-[5- [[Imino(nitroamino)methyl]amino]-2- [[(3-methyl-8- quinolinyl)sulfonyl]amino]-1- oxopentyl]-4-methyl-2- piperidinecarboxylic Acid; | Argatroban – In house impurity |
ADI-IMPM-01-00735 | 0 N-Nitro-1,2,3,4-tetradehydro Argatroban Ethyl Ester | IH | (2R,4R)-1-[(2S)-5- [[Imino(nitroamino)methyl]amino]-2-[[(3- methyl-8-quinolinyl)sulfonyl]amino]-1- oxopentyl]-4-methyl-2- piperidinecarboxylic Acid Ethyl Ester; | 25MG,50MG | Freezer | 74874-09-2 | 577.65 | C25H35N7O7S | [2R-[1(S*),2α,4β]]-1-[5- [[Imino(nitroamino)methyl]amino]-2- [[(3-methyl-8- quinolinyl)sulfonyl]amino]-1- oxopentyl]-4-methyl-2- piperidinecarboxylic Acid Ethyl Ester; | Argatroban – In house impurity |
ADI-IMPM-01-00736 | N-Nitro-1,2,3,4-tetradehydro (2S,4S)- Argatroban Benzyl Ester | IH | (2S,4S)-1-[(2S)-5- [[imino(nitroamino)methyl]amino]-2-[[(3- methyl-8-quinolinyl)sulfonyl]amino]-1- oxopentyl]-4-methyl-2- piperidinecarboxylic Acid Phenylmethyl Ester; | 25MG,50MG | Hygroscopic, Freezer, Under inert atmosphere | NA | 639.72 | C30H37N7O7S | NA | Argatroban – In house impurity |
ADI-IMPM-01-00737 | Arginine | API | L-Arginine; Arginine; Argivene; Detoxargin; L-(+)-Arginine; | 25MG,50MG | NA | 74-79-3 | 174.2 | C6H14N4O2 | Levargin; Minophagen A; NSC 203450; NSC 7914; R-Gene; | Arginine – API |
ADI-IMPM-01-00738 | Lysine | Imp A | L-Lysine; (S)-2,6- Diaminohexanoic Acid; (2S)-2,6- Diaminohexanoic Acid; 6-AminoL-norleucine; Malandil; α-Lysine | 25MG,50MG | Refrigerator | 56-87-1 | 146.19 | C6H14N2O2 | NA | Arginine – Impurity A |
ADI-IMPM-01-00739 | Citrulline | Imp B | N5-(Aminocarbonyl)-L-ornithine; N5-Carbamoyl-L-ornithine; αAmino-δ-ureidovaleric Acid; δUreidonorvaline; | 25MG,50MG | Refrigerator | 372-75-8 | 175.19 | C6H13N3O3 | (2S)-2-Amino-5- (carbamoylamino)pentanoic Acid; | Arginine – Impurity B |
ADI-IMPM-01-00740 | L-Ornithine | Imp C | (S)-2,5-Diaminopentanoic Acid; (2S)-2,5-Diaminopentanoic Acid; Ornithine; | 25MG,50MG | NA | 70-26-8 | 132.16 | C5H12N2O2 | NA | Arginine – Impurity C |
ADI-IMPM-01-00741 | Nα-Cbz-D-arginine | IH | N2-[(Phenylmethoxy)carbonyl]-Darginine; N2-Carboxy-D-arginine N2-Benzyl Ester; NBenzyloxycarbonyl-D-arginine | 25MG,50MG | NA | 6382-93-0 | 308.33 | C14H20N4O4 | NA | Arginine – In house Impurity |
ADI-IMPM-01-00742 | N-Psi-2,2,4,6,7- pentamethyldihydrobenzofuran-5- ylsulfonyl-D-arginine | IH | (R,E)-2-Amino-5- ((amino(2,2,4,6,7-pentamethyl2,3-dihydrobenzofuran-5- sulfonamido)methylene)amino)pe ntanoic Acid; | 25MG,50MG | NA | 200116-81-0 | 426.53 | C19H30N4O5S | NA | Arginine – In house Impurity |
ADI-IMPM-01-00743 | Z-D-Arg(Pbf)-OH*CHA | IH | Cyclohexanamine (R,E)-5- ((amino(2,2,4,6,7-pentamethyl2,3-dihydrobenzofuran-5- sulfonamido)methylene)amino)-2- (((benzyloxy)carbonyl)amino)pent anoate; | 25MG,50MG | NA | 200191-00-0 | 659.84 | C33H49N5O7S | NA | Arginine – In house Impurity |
ADI-IMPM-01-00744 | Arginine Hydrochloride | API | L-Arginine Hydrochloride; L-Arginine Monohydrochloride; | 25MG,50MG | Refrigerator | 1119-34-2 | 210.66 | C6H15ClN4O2 | Arginine Hydrochloride; Arginine Monochloride; Arginine Monohydrochloride; Argivene; Detoxargin; L-(+)-Arginine Monohydrochloride; Levargin; Minophagen A; NSC 203450; NS | Arginine Hydrochloride – API |
ADI-IMPM-01-00745 | Argireline Acetate | API | Argirelin Acetate(Acetyl Hexapeptide-3); (6S,9S,12S,15S,18S,21S)-21- Acetamido-1-amino-12-(3-amino3-oxopropyl)-6-carbamoyl-18-(2- carboxyethyl)-9-(3- guanidinopropyl)-1-imino-15-(2- (methylthio)ethyl)-8,11,14,17,20 | 25MG,50MG | NA | 616204-22-9 | 888.99 | C34H60N14O12S | Acetyl Hexapeptide; Ac-GluGlu-Met-Glu-Arg-Arg-NH2; Argireline Acetate anti-aging cosMetic peptide; N-Acetyl-Lalpha-glutamyl-L-alphaglutamyl-L-methionyl-Lglutaminyl-L-arginyl-Largininamide; Argireline acetate Ac-Glu-Glu-Met-A | Argireline Acetate – API |
ADI-IMPM-01-00746 | Aripiprazole | API | 7-[4-[4-(2,3-Dichlorophenyl)-1- piperazinyl]butoxy]-3,4-dihydro-2(1H)- quinolinone; | 25MG,50MG | Freezer | 129722-12-9 | 448.39 | C23H27Cl2N3O2 | 7-[4-[4-(2,3-Dichlorophenyl)-1- piperazinyl]butoxy]-3,4- dihydrocarbostyril; Abilify; Abilitat; OPC 14597; OPC 31; | Aripiprazole – API |
ADI-IMPM-01-00747 | 1-(2,3-Dichlorophenyl)piperazine | Imp B | 4-(2,3-Dichlorophenyl)piperazine; DCPP; 1-(2,3- Dichlorophenyl)piperazine; | 25MG,50MG | NA | 41202-77-1 | 231.12 | C10H12Cl2N2 | NA | Aripiprazole – Impurity B (Freebase) |
ADI-IMPM-01-00748 | Deschloroaripiprazole | Imp C | 7-[4-[4-(2-Chlorophenyl)-1- piperazinyl]butoxy]-3,4-dihydro-2(1H)- quinolinone; | 25MG,50MG | Refrigerator | 203395-81-7 | 413.94 | C23H28ClN3O2 | NA | Aripiprazole – Impurity C |
ADI-IMPM-01-00749 | 3,4-Dihydro-7-(4-hydroxybutoxy)-2(1H)- quinolinone | IH | Aripiprazole Hydroxy; 7-(4-Hydroxybutoxy)-3,4-dihydroquinolin-2(1H)-one; | 25MG,50MG | Refrigerator | 889443-20-3 | 235.28 | C13H17NO3 | Aripiprazole Related Compound B; | ; Aripiprazole – In house impurity |
ADI-IMPM-01-00750 | 1-(2,3-Dichlorophenyl)piperazine Hydrochloride | Imp B | N-(2,3-Dichlorophenyl)piperazine Hydrochloride; 4-(2,3- Dichlorophenyl)piperazine Hydrochloride; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 119532-26-2 | 267.58 | C10H13Cl3N2 | DCPP-Hydrochloride; Aripiprazole Related Compound C; | Aripiprazole – Impurity B |
ADI-IMPM-01-00751 | Aripiprazole N1-Oxide | Imp F | 7-[4-[4-(2,3-Dichlorophenyl)-1-oxido-1- piperazinyl]butoxy]-3,4-dihydro-2(1H)- quinolinone; Aripiprazole N-Oxide; | 25MG,50MG | NA | 573691-09-5 | 464.38 | C23H27Cl2N3O3 | 4-(2,3-Dichlorophenyl)-1-(4-((2-oxo1,2,3,4-tetrahydroquinolin-7- yl)oxy)butyl)piperazine 1-oxide; Aripiprazole Related Compound F | Aripiprazole – Impurity F |
ADI-IMPM-01-00752 | Dehydro Aripiprazole | Imp E | 7-[4-[4-(2,3-Dichlorophenyl)piperazin-1- yl]butoxy]quinolin-2(1H)-one; OPC 14857; | 25MG,50MG | Refrigerator | 129722-25-4 | 482.83 | C23H25Cl2N3O2 | DM 14857; 7-[4-[4-(2,3- Dichlorophenyl)-1- piperazinyl]butoxy]-2(1H)- quinolinone; Aripiprazole Related Compound G; | Aripiprazole – Impurity E |
ADI-IMPM-01-00753 | 7-(4-(4-(3,4- Dichlorophenyl)piperazin-1- yl)butoxy)-3,4-dihydroquinolin2(1H)-one | IH | Aripiprazole 3,4-Dichloro Impurity | 25MG,50MG | NA | NA | 448.39 | C23H27Cl2N3O2 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00754 | 1-(3,4-Dichlorophenyl)piperazine Hydrochloride | IH | Aripiprazole 3,4-Dichlorophenyl Piperazine Hydrochloride Impurity; | 25MG,50MG | NA | NA | 267.58 | C10H13Cl3N2 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00755 | 25MG,50MG | |||||||||
ADI-IMPM-01-00756 | 7-(4-Bromobutoxy)-3,4-dihydroquinolin-2- one | IH | 7-(4-Bromobutoxy)-3,4-dihydro-2(1H)- quinolinone; BBDQ; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 129722-34-5 | 296.18 | C13H16BrNO2 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00757 | 7-(4-Chlorobutoxy)-3,4-dihydro-2(1H)- quinolinone | IH | Chlorobutoxy Dihydroquinolinone; 7-(4- Chlorobutoxy)-3,4-dihydro-C2(1H)- quinoline; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 120004-79-7 | 253.72 | C13H16ClNO2 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00758 | 3,4-Dihydro-7-hydroxyquinoline-2(1H)-one | Imp A | Aripiprazole Dihydro Quinolinone; 7- Hydroxycarbostyril; 3,4-Dihydro-7- hydroxy-2(1H)-quinolinone; | 25MG,50MG | Freezer | 22246-18-0 | 163.17 | C9H9NO2 | 3,4-Dihydro-7-hydroxy-carbostyril; 7-Hydroxy-1,2,3,4-tetrahydro-2- quinolinone; | Aripiprazole – Impurity A |
ADI-IMPM-01-00759 | 1,4-Bis[3,4-dihydro-2(1H)-quinolinon-7- oxy]butane | IH | Aripiprazole Diquinoline Butanediol; 7,7′- [1,4-Butanediylbis(oxy)]bis[3,4-dihydro2(1H)-quinolinone; | 25MG,50MG | Refrigerator | 882880-12-8 | 380.44 | C22H24N2O4 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00760 | Aripiprazole N,N-Dioxide | IH | 7-[4-[4-(2,3-Dichlorophenyl)-1,4-dioxido1-piperazinyl]butoxy]-3,4-dihydro-2(1H)- quinolinone; | 25MG,50MG | NA | 573691-13-1 | 480.38 | C23H27Cl2N3O4 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00761 | Aripiprazole N4-Oxide | IH | 7-[4-[4-(2,3-Dichlorophenyl)-4-oxido-1- piperazinyl]butoxy]-3,4-dihydro-2(1H)- quinolinone; | 25MG,50MG | NA | 573691-11-9 | 464.38 | C23H27Cl2N3O3 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00762 | 1-(But-3-en-1-yl)-4-(2,3- dichlorophenyl)piperazine | IH | Aripiprazole Impurity 2; | 25MG,50MG | NA | NA | 285.21 | C14H18Cl2N2 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00763 | 7-(But-3-en-1-yloxy)-3,4- dihydroquinolin-2(1H)-one | IH | Aripiprazole impurity 3; | 25MG,50MG | NA | NA | 217.26 | C13H15NO2 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00764 | 2-Deschloro Aripiprazole | Imp D | 7-[4-[4-(3-Chlorophenyl)-1- piperazinyl]butoxy]-3,4-dihydro-2(1H)- quinolinone; | 25MG,50MG | Refrigerator | 203395-82-8 | 413.94 | C23H28ClN3O2 | NA | Aripiprazole – Impurity D |
ADI-IMPM-01-00765 | Desethylene Aripiprazole | IH | 7-[4-[2-(2,3-Dichlorophenyl)aminoethylamino]butoxy]-3,4-dihydro-2(1H)- quinolinone; | 25MG,50MG | NA | 1216394-63-6 | 422.35 | C21H25Cl2N3O2 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00766 | 1-[4-[4-(2,3-Dichlorophenyl)piperazin-1- yl]butyl]-7-hydroxy-3,4-dihydro- carbostyri | IH | 1-[4-[4-(2,3-Dichlorophenyl)piperazin-1- yl]butyl]-7-hydroxy-3,4-dihydrocarbostyril; | 25MG,50MG | NA | 1391054-74-2 | 450.4 | C23H29Cl2N3O2 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00767 | 1-(2,3-Dichlorophenyl)-4-(4- hydroxybutyl)piperazine Hydrochloride | IH | 4-(2,3-Dichlorophenyl)-1- piperazinebutanol Hydrochloride; 4-[4- (2,3-Dichlorophenyl)piperazin-1-yl]butan1-ol Hydrochloride; | 25MG,50MG | Refrigerator | NA | 339.69 | C14H21Cl3N2O | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00768 | 7-(4-Iodobutoxy)-3,4-dihydroquinolin-2- one | IH | 3,4-Dihydro-7-(4-iodobutoxy)-2(1H)- quinolinone; | 25MG,50MG | NA | 952308-47-3 | 345.18 | C13H16INO2 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00769 | Aripiprazole Dimer | Imp G | Aripiprazole 4,4′-dimer; 7,7′-[Ethane-1,1- diylbis[(2,3-dichlorobenzene-4,1- diyl)piperazine-4,1-diylbutane-4,1- diyloxy]]di[3,4-dihydroquinolin-2(1H)- one]; | 25MG,50MG | Refrigerator | 1797986-18-5 | 922.18 | C48H56Cl4N6O4 | Aripiprazole Dimer Impurity; 1,1’- (ethane-1,1-diyl)bis(2,3-dichloro-4- {4-[3,4-dihydroquinolin-2(1H)-one7-yloxybutyl]piperazin-1- yl}benzene); 7,7?-[Ethane-1,1- diylbis[(2,3-dichlorobenzene-4,1- diyl)piperizine-4,1-diylbutane-4,1- | Aripiprazole – Impurity G |
ADI-IMPM-01-00770 | 6-(4-((7-Oxo-5,6,7,8- tetrahydronaphthalen-2- yl)oxy)butoxy)-3,4-dihydroquinolin2(1H)-one | IH | 7,7′-(Butylenedioxy)di-3,4- dihydroquinolin-2(1H)-one; | 25MG,50MG | NA | NA | 379.45 | C23H25NO4 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00771 | 7-(4-(4-(2,3- Dichlorophenyl)piperazin-1- yl)butoxy)-1-(4-(2-oxo-3,4-dihydro1H-quinolin-7yl)butoxy)-3,4- dihydro-1H-quinolin-2-one | IH | Aripiprazole Impurity 4; | 25MG,50MG | NA | NA | 665.65 | C36H42Cl2N4O4 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00772 | ((7-(4-(4-(2,3- Dichlorophenyl)piperazin-1- yl)butoxy)-2-oxo-3,4- dihydroquinolin-1(2H)- yl)methoxy)methyl Dodecanoate | IH | Methyl Dodecanoate, ((7-(4-(4- (2,3-Dichlorophenyl)piperazin-1- yl)butoxy)-2-oxo-3,4- dihydroquinolin-1(2H)- yl)methoxy); | 25MG,50MG | NA | NA | 690.74 | C37H53Cl2N3O5 | NA | Aripiprazole – In house impurity |
ADI-IMPM-01-00773 | Aristolactam | API | 8-Methoxybenzo[f]-1,3- benzodioxolo[6,5,4-cd]indol-5(6H)-one; Aristolactam; | 25MG,50MG | NA | 13395-02-3 | 293.27 | C17H11NO4 | Aristolactam I; Aristololactam; Aristololactam I; NSC 87406 | Aristolactam – API |
ADI-IMPM-01-00774 | Aristolochic Acid Ia | IH | 8-Hydroxy-6-nitrophenanthro[4,3-d]-1,3- dioxole-5-carboxylic Acid; | 25MG,50MG | NA | 38965-71-8 | 327.25 | C16H9NO7 | NA | Aristolactam – In house impurity |
ADI-IMPM-01-00775 | Aristolochic Acid A | IH | 8-Methoxy-6-nitro-phenanthro[3,4-d]-1,3- dioxole-5-carboxylic Acid; | 25MG,50MG | Refrigerator | 313-67-7 | 341.27 | C17H11NO7 | Aristolochine; Aristolochia A; Aristolochic Acid; Aristolochic Acid 1; Aristolochic Acid I; NSC 11926; NSC 50413; TR 1736; Tardolyt; | Aristolactam – In house impurity |
ADI-IMPM-01-00776 | Aristolochic Acid B | IH | 6-Nitro-phenanthro[3,4-d]-1,3-dioxole-5- carboxylic Acid; Aristolochic Acid II; | 25MG,50MG | NA | 475-80-9 | 311.25 | C16H9NO6 | 3,4-(Methylenedioxy)-10- nitrophenanthrene-1-carboxylic Acid; | Aristolactam – In house impurity |
ADI-IMPM-01-00777 | Aristolochic Acid C | IH | 10-Hydroxy-6-nitro-phenanthro[3,4-d]-1,3- dioxole-5-carboxylic Acid; Aristolochic Acid IIIa; | 25MG,50MG | NA | 17413-38-6 | 327.25 | C16H9NO7 | NA | Aristolactam – In house impurity |
ADI-IMPM-01-00778 | Aristolochic Acid D | IH | 10-Hydroxy-8-methoxy-6- nitrophenanthro[3,4-d]-1,3-dioxole-5- carboxylic Acid; Aristolochic Acid IVa; | 25MG,50MG | NA | 17413-38-6 | 357.27 | C17H11NO8 | NA | Aristolactam – In house impurity |
ADI-IMPM-01-00779 | Aristolochic Acid E | IH | 8-Hydroxy-9-methoxy-6- nitrophenanthro[4,3-d]-1,3-dioxole-5- carboxylic Acid; | 25MG,50MG | NA | 107259-48-3 | 327.27 | C17H11NO8 | NA | Aristolactam – In house impurity |
ADI-IMPM-01-00780 | Artemether | API | (3R,5aS,6R,8aS,9R,10S,12R,12aR)- Decahydro-10-methoxy-3,6,9-trimethyl3,12-epoxy-12H-pyrano[4,3-j]-1,2- benzodioxepin; Decahydro-10-methoxy3,6,9-trimethyl-3,12-epoxy-12Hpyrano[4,3-j]-1,2-benzodioxepin; Artemos; | 25MG,50MG | Freezer | 71963-77-4 | 298.37 | C16H26O5 | Artenam; Artesaph; Artesian; Dihydroartemisinin Methyl Ether; Falcidol; Gvither; Larither; Malartem; SM 224; β-Artemether; β-Dihydroartemisinin Methyl Ether; | Artemether – API |
ADI-IMPM-01-00781 | Artemether Tetrahydrofuran Acetate | Imp C | [3aS-(3aα,4α,6aα,7β,8β,10α,10aS*)]- Octahydro-8-methoxy-4,7-dimethyl2H,10H-furo[3,2-i][2]benzopyran-10-ol Acetate; | 25MG,50MG | NA | 181528-64-3 | 298.37 | C16H26O5 | (3aS,4R,6aS,7R,8S,10R,10aR)- Octahydro-8-methoxy-4,7-dimethyl2H,10H-furo[3,2-i][2]benzopyran10-ol 10-Acetate, ; | Artemether – Impurity C |
ADI-IMPM-01-00782 | 2-(4-Methyl-2-oxo-3-(3- oxobutyl)cyclohexyl)propanal | IH | (2S,3R,6RS)-2-(3-Oxobutyl)-3-Methyl-6- [(R)-2-propanal]cyclohexanone; | 25MG,50MG | Hygroscopic, Freezer, Under inert atmosphere | 1093625-96-7 | 238.32 | C14H22O3 | NA | Artemether – In house impurity |
ADI-IMPM-01-00783 | Artemisitene | IH | (3R,5aS,6R,8aS,12S,12aR)-Octahydro3,6-dimethyl-9-methylene-3,12-epoxy12H-pyrano[4,3-j]-1,2-benzodioxepin10(3H)-one; | 25MG,50MG | Refrigerator | 101020-89-7 | 280.32 | C15H20O5 | (+)-Artemisitene; Dehydroqinghaosu; Methyl Artemisinin; | Artemether – In house impurity |
ADI-IMPM-01-00784 | α-Artemether | IH | Alpha-Artemether; (+)-α-Artemether; SM 229; α-Artemether; α-Dihydroartemisinin Μethyl Εther; | 25MG,50MG | NA | 71939-51-0 | 298.37 | C16H26O5 | (3R,5aS,6R,8aS,9R,10R,12R,12a R)-Decahydro-10-methoxy-3,6,9- trimethyl-3,12-epoxy-12Hpyrano[4,3-j]-1,2-benzodioxepin; Artemether Related Compound B | Artemether – In house impurity |
ADI-IMPM-01-00785 | ||||||||||
ADI-IMPM-01-00786 | Artemisinin | API | (3R,5aS,6R,8aS,9R,12S,12aR)- Octahydro-3,6,9-trimethyl-3,12-epox12Hpyrano[4,3-j]-1,2-benzodioxepin-10(3H)- one; | 25MG,50MG | Freezer | 63968-64-9 | 282.33 | C15H22O5 | Artemisine; Arteannuin; Huanghuahaosu; QHS; | Artemisinin – API |
ADI-IMPM-01-00787 | Dihydro Artemisinin | IH | (3R,5aS,6R,8aS,9R,10S,12R,12a R)-Decahydro-3,6,9-trimethyl3,12-epoxy-12H-pyrano[4,3-j]-1,2- benzodioxepin-10-ol; βDihydroartemisinin; Alaxin; Cotecxin; Cotexin; DHQHS 2; Dihydroartemisinine; | 25MG,50MG | Freezer | 71939-50-9 | 284.35 | C15H24O5 | NA | Artemisinin – In house impurity |
ADI-IMPM-01-00788 | Deoxy Artemisinin | IH | (3R,3aS,6R,6aS,9S,10aS,10bR)- Octahydro-3,6,9-trimethyl-10aH9,10b-epoxypyrano[4,3,2- jk][2]benzoxepin-2(3H)-one; Deoxyarteannuin; Deoxyartemisinin; Deoxyqinghaosu; | 25MG,50MG | Freezer | 72826-63-2 | 266.33 | C15H22O4 | NA | Artemisinin – In house impurity |
ADI-IMPM-01-00789 | Artemisininic Acid | IH | Artemisic Acid; 2- ((1R,4R,4aS,8aS)-4,7- Dimethyldecahydronaphthalen-1- yl)acrylic Acid; [1R- (1α,4β,4aβ,8aβ)]- 1,2,3,4,4a,5,6,8a-Octahydro-4,7- dimethyl-α-methylene-1- | 25MG,50MG | NA | 80286-58-4 | 234.33 | C15H22O2 | (1R,4R,4aS,8aR)- 1,2,3,4,4a,5,6,8a-Octahydro4,7-dimethyl-α-methylene-1- naphthaleneacetic Acid; Arteannuic Acid; Arteannuinic Acid; | Artemisinin – In house impurity |
ADI-IMPM-01-00790 | (5R)-5,8-Dimethyl2a,2a1,3,4,5,5a,6,8a-octahydro2H-naphtho[1,8-bc]furan-2-one | IH | Naphtho[1,8-bc]furan-2-one, (5R)- 5,8-dimethyl-2a,2a1,3,4,5,5a,6,8aoctahydro-2H-; | 25MG,50MG | NA | NA | 206.28 | C13H18O2 | NA | Artemisinin – In house impurity |
ADI-IMPM-01-00791 | (1aR,1bR,4aS,7S,7aS,9aR)-7,9aDimethyl-4-methyleneoctahydro1aH-oxireno[2′,3′:7,8]naphtho[8a,1- b]furan-3(4H)-one | IH | Furan-3(4H)-one, (1aR,1bR,4aS,7S,7aS,9aR)-7,9adimethyl-4-methyleneoctahydro1aHoxireno[2′,3′:7,8]naphtho[8a,1-b]; | 25MG,50MG | NA | NA | 248.32 | C15H20O3 | NA | Artemisinin – In house impurity |
ADI-IMPM-01-00792 | (2S,3R,6RS)-2-(3-Oxobutyl)-3- methyl-6-[(R)-2- propanal]cyclohexanone Mixture of Diastereomers | IH | (2S,3R,6RS)-α,4-Dimethyl-2-oxo3-(3- oxobutyl)cyclohexaneacetaldehyd e; (2S,3R,6RS)-α,4-Dimethyl-2- oxo-3-(3- oxobutyl)cyclohexaneacetaldehyd e; | 25MG,50MG | Hygroscop ic, Freezer, Under inert atmospher e | 1093625-96-7 | 238.32 | C14H22O3 | NA | Artemisinin – In house impurity |
ADI-IMPM-01-00793 | Anhydro Dihydro Artemisinin | IH | (3R,5aS,6R,8aS,12R,12aR)- 3,4,5,5a,6,7,8,8a-Octahydro3,6,9-trimethyl-3,12-epoxy-12Hpyrano[4,3-j]-1,2-benzodioxepin; (+)-9,10- Anhydrodehydroartemisinin; 9,10- | 25MG,50MG | Freezer | 82596-30-3 | 266.33 | C15H22O4 | NA | Artemisinin – In house impurity |
ADI-IMPM-01-00794 | 9-epi-Artemisinin | IH | (3R,5aS,6R,8aS,9S,12S,12aR)- Octahydro-3,6,9-trimethyl-3,12- epoxy-12H-pyrano[4,3-j]-1,2- benzodioxepin-10(3H)-one; (+)-9- Epiartemisinin; 11-epiArtemisinin; | 25MG,50MG | Freezer | 113472-97-2 | 282.33 | C15H22O5 | NA | Artemisinin – In house impurity |
ADI-IMPM-01-00795 | Artesunate | API | Butanedioic Acid Mono(3R,5aS,6R,8aS,9R,10R,12R,12a R)-decahydro-3,6,9-trimethyl-3,12-epoxy12H-pyrano[4,3-j]-1,2-benzodioxepin-10- yl] Ester; Artesunic Acid; | 25MG,50MG | Freezer | 88495-63-0 | 384.42 | C19H28O8 | NA | Artesunate – API |
ADI-IMPM-01-00796 | Glycan | Imp C | (3R,5aS,6R,8aS, 12R,12aR)- Octahydro-3,6,9-trimethyl-3,12- epoxy-12H-pyrano[4,3-j]-1,2- benzodioxepine; | 25MG,50MG | NA | NA | 266.33 | C15H22O4 | 9,10-Didehydro-10- deoxyartemisinin | Artesunate – Impurity C |
ADI-IMPM-01-00797 | Articaine Hydrochloride | API | Carticaine Hydrochloride; 4-Methyl-3-[2- (propylamino)propionamido]-2- thiophenecarboxylic Acid Methyl Ester Hydrochloride; | 25MG,50MG | NA | 23964-57-0 | 320.84 | C13H21ClN2O3S | 4-Methyl-3-[[1-oxo-2- (propylamino)propyl]amino]-2- thiophenecarboxylic Acid Methyl Ester Hydrochloride; Carticaine Hydrochloride; | Articaine Hydrochloride – API |
ADI-IMPM-01-00798 | Acetamidoarticaine Hydrochloride | Imp A | Methyl 3-[[2-(Propylamino)acetyl]amino]- 4-methyl-thiophene-2-carboxylate Hydrochloride; Methyl 4-methyl-3-(2- (propylamino)acetamido)thiophene-2- carboxylate Hydrochloride; | 25MG,50MG | NA | NA | 306.81 | C12H19ClN2O3S | NA | Articaine Hydrochloride – Impurity A |
ADI-IMPM-01-00799 | Articaine Isopropyl Ester Hydrochloride | Imp C | 1-Methyl-ethyl 4-Methyl-3-[[(2RS)-2- (propylamino)- propanoyl]amino]thiophene-2- carboxylateHydrochloride; | 25MG,50MG | NA | NA | 348.89 | C15H25ClN2O3S | NA | Articaine Hydrochloride – Impurity C |
ADI-IMPM-01-00800 | Ethylarticaine Hydrochloride | Imp D | Methyl 3-[[(2RS)-2- (Ethylamino)propanoyl]amino]-4- methylthiophene-2- carboxylateHydrochloride; Methyl 3-(2- (ethylamino)propanamido)-4- methylthiophene-2-carboxylate Hydrochloride; | 25MG,50MG | NA | NA | 306.81 | C12H19ClN2O3S | NA | Articaine Hydrochloride – Impurity D |
ADI-IMPM-01-00801 | Isopropylarticaine Hydrochloride | Imp E | Methyl 4-Methyl-3-[[(2RS)-2-[(1- methylethyl)amino]- propanoyl]amino]thiophene-2- carboxylate Hydrochloride; | 25MG,50MG | NA | NA | 320.84 | C13H21ClN2O3S | NA | Articaine Hydrochloride – Impurity E |
ADI-IMPM-01-00802 | Butylarticaine Hydrochloride | Imp G | Methyl3-[[(2RS)-2- (Butylamino)propanoyl]amino]-4- methylthiophene-2-carboxylate Hydrochloride; Methyl 3-(2- (butylamino)propanamido)-4- methylthiophene-2-carboxylate | 25MG,50MG | NA | 23964-59-2 | 334.86 | C14H23ClN2O3S | NA | Articaine Hydrochloride – Impurity G |
ADI-IMPM-01-00803 | 3-Aminoarticaine | IMP I | Methyl 3-Amino-4- methylthiophene-2-carboxylate; | 25MG,50MG | NA | 85006-31-1 | 171.22 | C7H9NO2S | NA | Articaine Hydrochloride – Impurity I |
ADI-IMPM-01-00804 | Ascomycin | API | Changchuanmycin; Immunomycin; FK 520; FR 520; FR 900520; L 683590; | 25MG,50MG | Freezer | 104987-12-4 | 792.01 | C43H69NO12 | NA | Ascomycin – API |
ADI-IMPM-01-00805 | Ascorbic Acid | API | L-Ascorbic Acid; (+)-Ascorbic Acid; 100M; L-threo-Ascorbic Acid; | 25MG,50MG | Refrigerator | 50-81-7 | 176.12 | C6H8O6 | 3-Oxo-L-gulofuranolactone; 3- keto-L-Gulofuranolactone; Adenex; Allercorb; Ascorbajen; Cantan; Cantaxin; Vitacimin; Vitacin; Vitamin C; Davitamon C; Laroscorbine; Vitamisin; | Ascorbic Acid – API |
ADI-IMPM-01-00806 | Furfural | Imp A | 2-Furancarboxaldehyde; 2-Furaldehyde; 2-Formylfuran; 2-Furanaldehyde; 2- Furancarbaldehyde; 2-Furancarbonal; 2- Furfural; 2-Furfuraldehyde; 2- Furylaldehyde; 2-Furylcarboxaldehyde; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 98-01-1 | 96.08 | C5H4O2 | Artificial ant oil; Fural; Furaldehyde; Furan-2- carboxaldehyde; Furancarbonal; Furfuraldehyde; Furfurol; Furfurole; Furfurylaldehyde; | Ascorbic Acid – Impurity A |
ADI-IMPM-01-00807 | (3R,4S,5R)-Butyl 3,4,5,6- tetrahydroxy-2-oxohexanoate | Imp B | (3R,4S,5R)-Butyl 3,4,5,6- tetrahydroxy-2-oxohexanoate; DSorbosonic Acid butyl Ester; | 25MG,50MG | NA | NA | 250.27 | C10H18O7 | NA | Ascorbic Acid – Impurity B |
ADI-IMPM-01-00808 | D-Xylo-hex-2-ulosonic Acid | ImP C | D-Sorbosonic Acid; D-Xylohexulosonic Acid; | 25MG,50MG | Room Temp | 16533-48-5 | 194.14 | C6H10O7 | 2-Ketogulonic acid; 2-Ketogulonic Acid | Ascorbic Acid – Impurity C |
ADI-IMPM-01-00809 | Methyl D-sorbosonate | Imp D | Methyl D-xylo-hex-2-ulosonate; | 25MG,50MG | NA | NA | 208.17 | C7H12O7 | NA | Ascorbic Acid – Impurity D |
ADI-IMPM-01-00810 | Oxalic Acid | Imp E | Ethanedioic Acid; Aktisal; Aquisal; DeerClean; NSC 132055; | 25MG,50MG | Refrigerator | 144-62-7 | 90.03 | C2H2O4 | NSC 151956; NSC 62774; NSC 76990; Ultraplast Activate S 52; | Ascorbic Acid – Impurity E |
ADI-IMPM-01-00811 | Erythorbic Acid | Imp F | (5R)-5-[(1R)-1,2-Dihydroxyethyl]-3,4- dihydroxyfuran-2(5H)-one; D(- ) – Isoascorbic Acid; D-erythro-Hex-2-enoic acid γ-lactone; Araboascorbic Acid; Araboascorbic Acid, D-; D-(-)- Isoascorbic Acid; | 25MG,50MG | NA | 89-65-6 | 176.12 | C6H8O6 | D-Araboascorbic Acid; DErythorbic Acid; D-Isoascorbic Acid; D-arabino-Ascorbic Acid; E 315; Erycorbin; Glucosaccharonic Acid; Isoascorbic Acid; Isovitamin C; Mercate 5; NSC 8117; NeoCebicure; Saccharosonic Acid; | Ascorbic Acid – Impurity F |
ADI-IMPM-01-00812 | L-threo-Hex- 2- enaric acid 1, 4-Lactone | Imp G | (2R)-2-[(2R)-3,4-Dihydroxy-5-oxo-2,5- dihydrofuran-2-yl]-2-hydroxyacetic Acid; 1, 4-Lactone-L-threo-hex- 2- enaric Acid; | 25MG,50MG | NA | 66757-69-5 | 190.11 | C6H6O7 | NA | Ascorbic Acid – Impurity G |
ADI-IMPM-01-00813 | L-threo-Hex- 2- enaric acid 1, 4-Lactone 6- Methyl Ester | Imp H | (R)-Methyl 2-((R)-3,4-dihydroxy-5-oxo2,5-dihydrofuran-2-yl)-2-hydroxyacetate; 1, 4-Lactone-L-threo-hex- 2- enaric Acid 6- Methyl Ester; | 25MG,50MG | NA | 122046-79-1 | 204.13 | C7H8O7 | NA | Ascorbic Acid – Impurity H |
ADI-IMPM-01-00814 | Ascorbyl Palmitate | IH | Ascorbyl Palmitate; Ascorbylpalmitic Acid; Cetyl ascorbate; L-Ascorbyl 6- Palmitate; L-Ascorbyl monoPalmitate; L-Ascorbyl Palmitate; Ondascora; Palmitoyl L-Ascorbic Acid; Quicifal; Ascorbic Acid Palmitate; Ascorbic | 25MG,50MG | Freezer, Under Inert Atmosphe re | 137-66-6 | 414.53 | C22H38O7 | L-Ascorbic Acid, 6- hexadecanoate, L-Ascorbic Acid, 6-Palmitate (8CI); Palmitic Acid, 6-Ester with Ascorbic Acid (6CI,7CI); 6- Hexadecanoyl-L-ascorbic Acid; 6-Monopalmitoyl-Lascorbate; 6-O-Palmitoyl-L | Ascorbic Acid – In house impurity |
ADI-IMPM-01-00815 | Asenapine | API | (3aR,12bR)-rel-5-Chloro-2,3,3a,12btetrahydro-2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5-c]pyrrole; | 25MG,50MG | Freezer, Under Inert Atmosphe re | 65576-45-6 | 285.77 | C17H16ClNO | Trans-5-Chloro-2,3,3a,12btetrahydro-2-methyl-1Hdibenz[2,3:6,7] oxepino[4,5- c]pyrrole; | Asenapine – API |
ADI-IMPM-01-00816 | Asenapine N-Oxide | IH | (3aR-trans)-5-Chloro-2,3,3a,12btetrahydro-2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5-c]pyrrole 2- Oxide; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 128949-51-9 | 301.77 | C17H16ClNO2 | NA | Asenapine – In house impurity |
ADI-IMPM-01-00817 | 3-[2-(4-Chlorophenoxy)phenyl]-1,5- dihydro-4-hydroxy-1-methyl-2H-pyrrol-2- one | IH | 3-[2-(4-Chlorophenoxy)phenyl]-1,5- dihydro-4-hydroxy-1-methyl-2H-pyrrol-2- one; | 25MG,50MG | NA | 934996-78-8 | 315.75 | C17H14ClNO3 | NA | Asenapine – In house impurity |
ADI-IMPM-01-00818 | N-Desmethyl Asenapine Hydrochloride | IH | (3aR,12bR)-rel-5-Chloro-2,3,3a,12btetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5- c]pyrrole Hydrochloride; | 25MG,50MG | Freezer | 1170701-78-6 | 308.2 | C16H15Cl2NO | NA | Asenapine – In house impurity |
ADI-IMPM-01-00819 | 2,3-Dihydro-1-oxo Asenapine | IH | 5-Chloro-2,3-dihydro-2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5-c]pyrrol-1- one; | 25MG,50MG | NA | 934996-79-9 | 297.74 | C17H12ClNO2 | NA | Asenapine – In house impurity |
ADI-IMPM-01-00820 | Asenapine N-β-D-Glucuronide Trifluoroacetic Acid Salt (Mixture of Diastereomers) | IH | (3aR-trans)-5-Chloro-2,3,3a,12btetrahydro-2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5- c]pyrrole β-DGlucopyranosiduronic Acid Trifluoroacetic Acid Salt (mixture of diastereomers);Asenapine N-β | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | NA | 575.92 | C23H25CF3NO9 | NA | Asenapine – In house impurity |
ADI-IMPM-01-00821 | Aspartame | API | L-α-Aspartyl-L-phenylalanine 2-Methyl Ester; Canderel; | 25MG,50MG | Refrigerator | 22839-47-0 | 294.3 | C14H18N2O5 | Dipeptide Sweetener; E 951; Equal; Finn; L-Aspartame; NutraSweet; Pal Sweet; Palsweet Diet; Sweet Dipeptide; Zero-Cal; αAspartame; α-L-Aspartyl-Lphenylalanine Methyl Ester; αSweet; | Aspartame – API |
ADI-IMPM-01-00822 | (2S,5S)-5-Benzyl-3,6-dioxo-2- piperazineacetic Acid | Imp A | 5-Benzyl-3,6-dioxo-2-piperazineacetic acid; | 25MG,50MG | Refrigerator | *5262-10-2 | 262.26 | C13H14N2O4 | NA | Aspartame – Impurity A |
ADI-IMPM-01-00823 | L-Aspartyl-L-phenylalanine | Imp B | L-α-Aspartyl-L-phenylalanine; N-L-αAspartyl-L-phenylalanine; | 25MG,50MG | NA | 13433-09-5 | 280.28 | C13H16N2O5 | Demethylaspartame; L-Aspartyl-Lphenylalanine; L-α-Aspartyl-Lphenylalanine; αAspartylphenylalanine; α-LAspartyl-L-phenylalanine; Thiamine Impurity B; | Aspartame – Impurity B |
ADI-IMPM-01-00824 | (S)-2-Amino-3-phenylpropionic acid | Imp C | L-Phenylalanine; (2S)-2-Amino-3- phenylpropanoic Acid; (S)-(-)- Phenylalanine; | 25MG,50MG | Room Temp | 63-91-2 | 165.19 | C9H11NO2 | (S)-α-Amino-β-phenylpropionic Acid; (S)-α-Aminohydrocinnamic Acid; (S)-α-Aminobenzenepropanoic Acid; | Aspartame – Impurity C |
ADI-IMPM-01-00825 | Aspartic Acid | API | (S)-(+)-Aminosuccinic acid; (S)- Aminobutanedioic acid; L-Aspartic acid; (S)-2-Aminobutanedioic Acid; | 25MG,50MG | Room Temp | 56-84-8 | 133.1 | C4H7NO4 | L-(+)-Aspartic Acid; LAminosuccinic Acid; L-Asparagic Acid; L-Asparaginic Acid; NSC 3973; NSC 79553; | Aspartic Acid – API |
ADI-IMPM-01-00826 | Indole-3-acetyl-L-Aspartic Acid | IH | (2S)-2-[[2-(1H-Indol-3- yl)acetyl]amino]butanedioic Acid; Indole-3-acetyl-L-aspartic acid Plant | 25MG,50MG | NA | 2456-73-7 | 290.27 | C14H14N2O5 | Indole-3-acetyl L-Aspartic Acid; (S)-2-(2-(1H-Indol-3- yl)acetamido)succinic Acid; | Aspartic Acid – In house impurity |
ADI-IMPM-01-00827 | Astemizole | API | 1-[(4-Fluorophenyl)methyl]-N-[1-[2-(4- methoxyphenyl)ethyl]-4-piperidinyl]-1Hbenzimidazol-2-amine; | 25MG,50MG | Refrigerator | 68844-77-9 | 458.57 | C28H31FN4O | Astemisan; Hismanal; Histamen; Paralergin; R 42512; R 43512; Retolen; Waruzol; | Astemizole – API |
ADI-IMPM-01-00828 | O-Desmethyl Astemizole | IH | Desmethyl Astemizole Hydrochloride; 4- [2-[4-[[1-[(4-Fluorophenyl)methyl]-1Hbenzimidazol-2-yl]amino]-1- piperidinyl]ethyl]phenol; | 25MG,50MG | Refrigerator | r 73736-50-2 | 444.54 | C27H29FN4O | Desmethylastemizole; ODemethylastemizole; R 44271; | Astemizole – In house impurity |
ADI-IMPM-01-00829 | N-Ethoxycarbonyl Norastemizole | IH | Ethyl 4-[[1-[(4- Fluorophenyl)methyl]-1hbenzimidazol-2- yl]amino]piperidine-1-carboxylate; | 25MG,50MG | NA | 84501-68-8 | 396.46 | C22H25FN4O2 | 4-[[1-[(4- Fluorophenyl)methyl]-1Hbenzimidazol-2-yl]amino]-1- piperidinecarboxylic acid Ethyl Ester; | Astemizole – In house impurity |
ADI-IMPM-01-00830 | Atazanavir Sulfate | API | Dimethyl (3S,8S,9S,12S)-9-Benzyl3,12,di-tert-butyl-8-hydroxy-4,11-dioxo-6- (p-2-pyridylbenzyl)-2,5,6,10,13- pentaazatetradecanedioate Sulfate (1:1); Atazanavir Bisulfate Salt | 25MG,50MG | Refrigerator | 229975-97-7 | 802.93 | C38H54N6O11S | 2,5,6,10,13- Pentaazatetradecanedioic acid, 3- 12-bis(1,1-dimethylethyl)-8- hydroxy-4,11-dioxo-9- (phenylmethyl)-6-[[-4-(2- pyridinyl)phenyl]methyl]-, dimethyl ester, (3S,8S,9S,12S )-, Sulfate (1:1) (salt); 3,12-Bis(1,1- dimethylethyl)-8-hydroxy-4,11- dioxo-9-(phenylmethyl)-6-[[4-(2- pyridinyl)phenyl]methyl]-dimethyl |
Atazanavir Sulfate – API |
ADI-IMPM-01-00831 | Pyridinyl Benzoic Acid | IH | 4-(2-Pyridinyl)benzoic Acid; 4-(2- Pyridyl)benzoic Acid; 4-(Pyridin-2- yl)benzoic Acid; | 25MG,50MG | NA | 4385-62-0 | 199.21 | C12H9NO2 | NA | Atazanavir Sulfate – In house impurity |
ADI-IMPM-01-00832 | 5-Hydroxymethyl-2-furaldehyde | IH | HMF; 2-Hydroxymethyl-5-furfural; 5-H,5- (Hydroxymethyl) furfural; 5-HMF; 5- (Hydroxymethyl)-2-furancarboxaldehyde; 2-Formyl-5-hydroxymethylfuran; | 25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphere | 67-47-0 | 126.11 | C6H6O3 | 5-(Hydroxymethyl)-2- furancarbonal; 5- (Hydroxymethyl)furfural; 5- Hydroxymethylfurfurol; 5- Oxymethylfurfurole; | Atazanavir Sulfate – In house impurity |
ADI-IMPM-01-00833 | Pyridinyl Benzaldehyde | IH | 4-(2-Pyridinyl)phenylaldyhyde; 4-(2- Pyridinyl)benzaldehyde; 2-(pFormylphenyl)pyridine; | 25MG,50MG | Freezer | 127406-56-8 | 183.21 | C12H9NO | 4-(2-Pyridyl)benzaldehyde; 4- (Pyridin-2-yl)benzaldehyde; | Atazanavir Sulfate – In house impurity |
ADI-IMPM-01-00834 | Atazanavir R,S,S,S-diastereomer | IH | (3R,8S,9S,12S)-Atazanavir; Dimethyl (3R,8S,9S,12S)-9- Benzyl-3,12,di-tert-butyl-8- hydroxy-4,11-dioxo-6-(p-2- pyridylbenzyl)-2,5,6,10,13- pentaazatetradecanedioate; | 25MG,50MG | NA | 1332981-14-2 | 704.86 | C38H52N6O7 | (3R,8S,9S,12S)-3,12-Bis(1,1- dimethylethyl)-8-hydroxy4,11-dioxo-9-(phenylmethyl)- 6-[[4-(2- pyridinyl)phenyl]methyl]- 2,5,6,10,13- pentaazatetradecanedioic Acid 1,14-Dimethyl Ester; | Atazanavir Sulfate – In house impurity |
ADI-IMPM-01-00835 | Atazanavir | IH | Dimethyl (3S,8S,9S,12S)-9- benzyl-3,12,di-tert-butyl-8- hydroxy-4,11-dioxo-6-(p-2- pyridylbenzyl)-2,5,6,10,13- pentaazatetradecanedioate; (3S,8S,9S,12S)-2,5,6,13- Pentaazatetradecanedioic Acid; | 25MG,50MG | Freezer | 198904-31-3 | 704.86 | C38H52N6O7 | 3,12-Bis(1,1-dimethylethyl)-8- hydroxy-4,11-dioxo-9- (phenylmethyl)-6-[[4-(2- pyridinyl)phenyl]methyl]- dimethyl Ester; | Atazanavir Sulfate – In house impurity |
ADI-IMPM-01-00836 | (2R,3R)-3-[(tButoxycarbonyl)amino]-4-phenyl1,2-epoxybutane | IH | tert-Butyl ((R)-1-((R)-oxiran-2-yl)- 2-phenylethyl)carbamate; tertButyl ((R)-1-((R)-oxiran-2-yl)-2- phenylethyl)carbamate; | 25MG,50MG | NA | 156474-21-4 | 263.33 | C15H21NO3 | NA | Atazanavir Sulfate – In house impurity |
ADI-IMPM-01-00837 | Atazanavir Benzylidenehydrazine Carbamate | IH | (S,S,S)-Atazanavir Benzylidenehydrazine Carbamate; Methyl [(S)-1-{[(2S ,3S )-3- Hydroxy-1-phenyl-4-{1-[4- (pyridin-2- yl)benzyl]-2-[4-(pyridin2- yl)benzylidene]hydrazinyl}butan-2- yl]amino}-3,3-dimethyl-1- oxobutan-2- yl]carbamate; Atazanavir Benzylidenehydrazine | 25MG,50MG | NA | NA | 698.85 | C42H46N6O4 | NA | Atazanavir Sulfate – In house impurity |
ADI-IMPM-01-00838 | Atazanavir S,S,S,R-Diastereomer Analog | IH | (3S,8S,9S,12R)-Atazanavir; (3S,8S,9S,12R)-3,12-Bis(1,1- dimethylethyl)-8-hydroxy-4,11- dioxo-9-(phenylmethyl)-6-[[4-(2- pyridinyl)phenyl]methyl]- 2,5,6,10,13- pentaazatetradecanedioic Acid 1,14-Dimethyl Ester; | 25MG,50MG | NA | 1332981-16- 4 | 704.86 | C38H52N6O7 | NA | Atazanavir Sulfate – In house impurity |
ADI-IMPM-01-00839 | Atazanavir S,R,R,S-Diastereomer | IH | (3S,8R,9R,12S)-Atazanavir; (3S,8R,9R,12S)-3,12-Bis(1,1- dimethylethyl)-8-hydroxy-4,11- dioxo-9-(phenylmethyl)-6-[[4-(2- pyridinyl)phenyl]methyl]- 2,5,6,10,13- pentaazatetradecanedioic Acid 1,14-Dimethyl Ester; | 25MG,50MG | NA | NA | 704.86 | C38H52N6O7 | NA | Atazanavir Sulfate – In house impurity |
ADI-IMPM-01-00840 | Atazanavir Benzylidenehydrazine Analogue | IH | (2S,3S)-3-Amino-4-phenyl-1-((E)- 1-(4-(pyridin-2-yl)benzyl)-2-(4- (pyridin-2- yl)benzylidene)hydrazinyl)butan-2- ol; | 25MG,50MG | NA | NA | 527.66 | C34H33N5O | NA | Atazanavir Sulfate – In house impurity |
ADI-IMPM-01-00841 | Atenolol | API | 4-[2-Hydroxy-3-[(1- methylethyl)amino]propoxyl]benzeneacet amide; | 25MG,50MG | Freezer | 29122-68-7 | 266.34 | C14H22N2O3 | 2-[p-[2-Hydroxy-3- (isopropylamino)propoxy]phenyl]ac etamide; (RS)-Atenolol; (+/-)- Atenolol; ICI-66082; Atehexal; Atenol; Cuxanorm; Myocord; Normalol; Normiten; Uniloc; | Atenolol – API |
ADI-IMPM-01-00842 | 4-Hydroxyphenylacetamide | Imp A | 4-Hydroxybenzeneacetamide; (pHydroxyphenyl)acetamide; | 25MG,50MG | Refrigerator | 17194-82-0 | 151.16 | C8H9NO2 | 2-(4-Hydroxyphenyl)acetamide; 2- (p-Hydroxyphenyl)acetamide; NSC 187193; p- (Carbamoylmethyl)phenol; | Atenolol – Impurity A |
ADI-IMPM-01-00843 | Des(isopropylamino) Atenolol Diol | Imp B | 4-(2,3- Dihydroxypropoxy)benzeneacetamide; 2- [4-[(2RS)-2,3- dihydroxypropoxy]phenyl]acetamide; | 25MG,50MG | NA | 61698-76-8 | 225.24 | C11H15NO4 | NA | Atenolol – Impurity B |
ADI-IMPM-01-00844 | 4-(2,3-Epoxypropoxy)phenylacetamide | Imp c | 2-(4-Oxiranylmethoxy-phenyl)- acetamide; 2-[4-[[(2RS)-oxiran-2- yl]methoxy]phenyl]acetamide; | 25MG,50MG | Freezer, Under Inert Atmosphere | 29122-69-8 | 207.23 | C11H13NO3 | NA | Atenolol – Impurity C |
ADI-IMPM-01-00845 | 4-(3-Chloro-2- hydroxypropoxy)benzeneacetamide | Imp D | 2-[4-[(2RS)-3-chloro-2- hydroxypropoxy]phenyl]acetamide; | 25MG,50MG | NA | 115538-83-5 | 243.69 | C11H14ClNO3 | NA | Atenolol – Impurity D |
ADI-IMPM-01-00846 | 4,4′-[(2-Hydroxy-1,3- propanediyl)bis(oxy)]bisbenzeneacetamide | Imp E | 2,2′-[2-hydroxypropan-1,3-diylbis(oxy-4,1- phenylene)]diacetamide; | 25MG,50MG | NA | 141650-31-9 | 358.39 | C19H22N2O5 | NA | Atenolol – Impurity E |
ADI-IMPM-01-00847 | 4,4′-[[(1-Methylethyl)imino]bis[(2-hydroxy3,1-propanediyl)oxy]]bisbenzeneacetamide | Imp F | 2,2′-[(1-methylethyl)iminobis(2- hydroxypropan-3,1-diyloxy-4,1- phenylene)]diacetamide; | 25MG,50MG | NA | 87619-83-8 | 473.56 | C25H35N3O6 | NA | Atenolol – Impurity F |
ADI-IMPM-01-00848 | Metoprolol Acid | Imp G | 2-[4-[(2RS)-2-hydroxy-3-[(1- methylethyl)amino]propoxy]phenyl]acetic acid; | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 56392-14-4 | 267.32 | C14H21NO4 | 4-(2-Hydroxy-3- isopropylaminopropoxy)phenylacet ic Acid; Atenolol Acid; H 117/04; SL 77-010; 4-[2-Hydroxy-3-[(1- methylethyl)amino]propoxy]benzen eacetic Acid; | Atenolol – Impurity G |
ADI-IMPM-01-00849 | 2-[4-[(2RS)-2-hydroxy-3-[(1- methylethyl)amino]propoxy]phenyl]acetoni trile | Imp H | Atenolol Impurity H; [p-[2-hydroxy-3- (isopropylamino)propoxy]phenyl]acetonit rile; | 25MG,50MG | NA | 29277-73-4 | 248.32 | C14H20N2O2 | NA | Atenolol – Impurity H |
ADI-IMPM-01-00850 | 2-[4-[(2RS)-3-(Ethylamino)-2- hydroxypropoxy]phenyl]acetamide | Imp I | 2-[4-[(2RS)-3-(Ethylamino)-2- hydroxypropoxy]phenyl]acetamide | 25MG,50MG | NA | NA | 252.31 | C13H20N2O3 | NA | Atenolol – Impurity I |
ADI-IMPM-01-00851 | 4-(3-Amino-2- hydroxypropoxy)phenylacetamide | Imp J | 2[4-(3-Amino-2-hydroxy-propoxy)- phenyl]-acetamide; 2-[4-[(2RS)-3- Amino-2- hydroxypropoxy]phenyl]acetamid e; | 25MG,50MG | Refrigerator | 81346-71-6 | 224.26 | C11H16N2O3 | NA | Atenolol – Impurity J |
ADI-IMPM-01-00852 | Atenolol S-Isomer | IH | (S)-Atenolol; 4-[(2S)-2-Hydroxy-3-[(1- methylethyl)amino]propoxy]benzeneacet amide; (-)-Atenolol; | 25MG,50MG | Freezer | 93379-54-5 | 266.34 | C14H22N2O3 | (-)-Atenolol; (S)-Atenolol; Esatenolol; S-(-)-Atenolol; (S)-2-(4- (2-Hydroxy-3- (isopropylamino)propoxy)phenyl)a cetamide; | Atenolol – In house impurity |
ADI-IMPM-01-00853 | Atomoxetine Hydrochloride | API | Atomexine Hydrochloride; (R)-NMethyl-γ-(2- methyl-phenoxy)benzenepropana mine Hydrochloride; (R)-N-methyl3-phenyl-3-(o-tolyloxy)propan-1- | 25MG,50MG | Freezer | 82248-59-7 | 291.82 | C17H22ClNO | (R)-Tomoxetine Hydrochloride; (R)-N-Methyl- (2- methylphenoxy)benzenepro panamine Hydrochloride; RTomexetine Hydrochloride | Atomoxetine Hydrochloride – API |
ADI-IMPM-01-00854 | (S)-Atomoxetine Hydrochloride | Imp B | ent S-(+)-Atomoxetine Hydrochloride; (3S)-N-Methyl-3- (2-methylphenoxy)-3- phenylpropan-1-amine Hydrochloride; (S)-Tomoxetine Hydrochloride; | 25MG,50MG | NA | 82857-39-4 | 291.82 | C17H22ClNO | (γS)-N-Methyl-γ-(2- methylphenoxy)benzenepro panamine Hydrochloride; (S)- (+)-Tomoxetine Hydrochloride; | Atomoxetine Hydrochloride – Impurity B |
ADI-IMPM-01-00855 | p-Methyl Atomoxetine Hydrochloride | Imp c | (3R)-N-Methyl-3-(4- methylphenoxy)-3-phenylpropan1-amine Hydrochloride; N-Methylγ-(4- methylphenoxy)benzenepropana | 25MG,50MG | NA | 873310-31-7 | 291.82 | C17H22ClNO | N-Methyl-3-phenyl-3-(ptolyloxy)propan-1-amine Hydrochloride; Atomoxetine Related Compound C | Atomoxetine Hydrochloride – Impurity C |
ADI-IMPM-01-00856 | m-Methyl Atomoxetine Hydrochloride | Imp D | (3R)-N-Methyl-3-(3- methylphenoxy)-3-phenylpropan1-amine Hydrochloride; N-Methylγ-(3- methylphenoxy)benzenepropana | 25MG,50MG | NA | 873310-28-2 | 291.82 | C17H22ClNO | Atomoxetine Related Compound B; | Atomoxetine Hydrochloride – Impurity D |
ADI-IMPM-01-00857 | 3-(Methylamino)-1-phenylpropan-1- ol | Imp H | N-Methyl-3-hydroxy-3- phenylpropylamine; 3-Hydroxy-Nmethyl-3-phenylpropylamine; | 25MG,50MG | NA | 115290-81-8 | 165.23 | C10H15NO | Atomoxetine Related Compound A; | Atomoxetine Hydrochloride – Impurity H |
ADI-IMPM-01-00858 | Atorvastatin Acid | API | (3R,5R)-7-[2-(4-Fluorophenyl)-3- phenyl-4-(phenylcarbamoyl)-5- propan-2-ylpyrrol-1-yl]-3,5- dihydroxyheptanoic Acid; | 25MG,50MG | NA | 134523-00-5 | 558.64 | C33H35FN2O5 | (3R,5R)-2-(4-Fluorophenyl)- 3,5-dihydroxy-5-(1- methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1Hpyrrole-1-heptanoic acid | Atorvastatin Acid – API |
ADI-IMPM-01-00859 | Defluoro Atorvastatin Calcium Salt | Imp A | (βR,δR)-β,δ-Dihydroxy-2-(1-methylethyl)- 4,5-diphenyl-3-[(phenylamino)carbonyl]- 1H-pyrrole-1-heptanoic Acid Calcium Salt (2:1); | 25MG,50MG | NA | 433289-83-9 | 1119.36 | C66H68CaN4O10 | Atorvastatin Related Compound A | Atorvastatin Acid – Impurity A |
ADI-IMPM-01-00860 | (3S,5R)-Atorvastatin Calcium Salt | Imp B | (βS,δR)-2-(4-Fluorophenyl)-β,δdihydroxy-5-(1-methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1H-pyrrole-1- heptanoic Acid Calcium Salt; | 25MG,50MG | NA | 887196-25-0 | 1155.34 | C66H68CaF2N4O10 | 3S,5R)-7-[3-(Phenylcarbamoyl)-5- (4-fluorophenyl)-2-isopropyl-4- phenyl-1H-pyrrol-1-yl]-3,5- dihydroxyheptanoic Acid; Atorvastatin Related Compound B; | Atorvastatin Acid – Impurity B |
ADI-IMPM-01-00861 | Difluoro Atorvastatin Calcium Salt | Imp C | (βR,δR)-2,3-Βis(4-fluorophenyl)-β,δdihydroxy-5-(1-methylethyl)-4- [(phenylamino)carbonyl]-1H-pyrrole-1- heptanoic Αcid Calcium Salt; | 25MG,50MG | NA | 693793-53-2 | 1191.3 | C66H68CaF2N4O10 | Atorvastatin Related Compound C; | Atorvastatin Acid – Impurity C |
ADI-IMPM-01-00862 | Atorvastatin Epoxydione Impurity | Imp D | 3-(4-Fluorobenzoyl)-2-isobutyryl-3- phenyl-oxirane-2-carboxylic acid phenylamide; | 25MG,50MG | Refrigerator | 148146-51-4 | 431.46 | C26H22FNO4 | 3-(4-Fluorobenzoyl)-2-(2-methyl-1- oxopropyl)-N,3- diphenyloxiranecarboxamide; Atorvastatin Related Impurity D; | Atorvastatin Acid – Impurity D |
ADI-IMPM-01-00863 | (3S,5S)-Atorvastatin Sodium Salt | Imp E | (βS,δS)-2-(4-Fluorophenyl)-β,δdihydroxy-5-(1-methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1H-pyrrole-1- heptanoic Acid Sodium; 3S,5SAtorvastatin Sodium; | 25MG,50MG | Freezer | 501121-34-2 | 580.62 | C33H34FN2NaO5 | NA | Atorvastatin Acid – Impurity E |
ADI-IMPM-01-00864 | (3S,5S)-Atorvastatin Calcium Salt | Imp E | (βS,δS)-2-(4-Fluorophenyl)-β,δdihydroxy-5-(1-methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1H-pyrrole-1- heptanoic Acid Calcium Salt; Atorvastatin Hemicalcium; | 25MG,50MG | Freezer | 1105067-88-6 | 1155.34 | C66H68CaF2N4O10 | CI 981 Calcium Salt; Lipitor Calcium Salt; Sortis Calcium Salt; Tahor Calcium Salt; YM 548 Calcium Salt; (3S,5S)-7-(2-(4- Fluorophenyl)-5-isopropyl-3-phenyl4-(phenylcarbamoyl)-1H-pyrrol-1- yl)-3,5-dihydroxyheptanoate Calcium; Atorvastatin Related Compound E; | Atorvastatin Acid – Impurity E |
ADI-IMPM-01-00865 | Atorvastatin Amide Impurity Calcium Salt | Imp F | (3R,5R)-7-[[(3R,5R)-7-[2-(4- Fluorophenyl)-5-(1-methylethyl)-3- phenyl-4-[(phenylamino)carbonyl]- 1H-pyrrol-1-yl]-3,5-dihydroxy-1- oxoheptyl]amino]-3,5-dihydroxyheptanoic Acid Calcium Salt; | 25MG,50MG | Hygroscop ic, Freezer, Under Inert Atmosphere | 1105067-87- 5 | 736.86 | C40H48FN3O8•0.5C | Atorvastatin Amide Acid Calcium Salt; Atorvastatin DiAmide Acid Calcium Salt; Atorvastatin Diamino Impurity Calcium Salt; | Atorvastatin Acid – Impurity F |
ADI-IMPM-01-00866 | Atorvastatin Amide Impurity | Imp F | Atorvastatin Amide Acid; Atorvastatin Di-Amide Acid; Atorvastatin Diamino Impurity; (3R,5R)-7-{(3R,5R)-7-[2-(4- Fluorophenyl)-5-isopropyl-3- phenyl-4-(phenylcarbamoyl)-1Hpyrrol-1-yl]-3,5- dihydroxyheptanamido}-3 | 25MG,50MG | Hygroscop ic, Freezer, Under Inert Atmosphere | 887196-24-9 | 717.82 | C40H48FN3O8 | NA | Atorvastatin Acid – Impurity F |
ADI-IMPM-01-00867 | O-Methyl Atorvastatin Calcium Salt | Imp G | (βR,δR)-2-(4-Fluorophenyl)-δ-hydroxy-βmethoxy-5-(1-methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1H-pyrrole-1- heptanoic Acid Calcium Salt; | 25MG,50MG | NA | 887196-29-4 | 591.7 | C34H37FN2O5•0.5Ca | NA | Atorvastatin Acid – Impurity G |
PA 01 83080 | Atorvastatin Lactone | Imp H | 5-(4-Fluorophenyl)-2-(1-methylethyl)-N,4- diphenyl-1-[2-[(2R,4R)-tetrahydro-4- hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1Hpyrrole-3-carboxamide; | 25MG,50MG | Freezer, Under Inert Atmosphere | 125995-03-1 | 540.62 | C33H33FN2O4 | (4R,6R)-6-[2-[2-(4-Fluorophenyl)- 5-(1-methylethyl)-3-phenyl-4- (phenylcarbamoyl)-1H-pyrrol-1- yl]ethyl]-4-hydroxytetrahydro-2Hpyran-2-one; Atorvastatin δLactone; Atorvastatin Related Compound H | Atorvastatin Acid – Impurity H |
PA 01 83090 | Atorvastatin Acetonide tert-Butyl Ester | Imp I | (4R,6R)-6-[2-[2-(4-Fluorophenyl)-5-(1- methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1H-pyrrol-1- yl]ethyl]-2,2-dimethyl-1,3-dioxane-4- acetic Acid 1,1-Dimethylethyl Ester; Atorvastatin Ketal Impurity | 25MG,50MG | Refrigerator | 125971-95-1 | 654.81 | C40H47FN2O5 | tert-Butyl 2-((4R,6R)-6-{2-[2-(4- fluorophenyl)-5-isopropyl-3-phenyl4-(phenylcarbamoyl)-1H-pyrrol-1- yl]ethyl}-2,2-dimethyl-1,3-dioxan-4- yl)acetate; Atorvastatin Related Compound I; | Atorvastatin Acid – Impurity I |
PA 01 83150 | (5R)-7-[2-(4-fluorophenyl)-3-phenyl-4- (phenylcarbamoyl)-5-(1-methylethyl)-1Hpyrrol-1-yl]-5- hydroxy-3-oxoheptanoic Acid Sodium Salt | Imp O | rac-3-Oxo Atorvastatin Sodium Salt; 3- Oxo-Atorvastatin; 2-(4-Fluorophenyl)-δhydroxy-5-(1-methylethyl)-β-oxo-3- phenyl-4-[(phenylamino)carbonyl]-1Hpyrrole-1-heptanoic Acid Sodium Salt; | 25MG,50MG | Freezer | 1391052-00-8 | 578.61 | C33H32FN2NaO5 | NA | Atorvastatin Acid – Impurity O |
PA 01 83510 | Atorvastatin tert-Butyl Ester | IH | (βR,δR)-2-(4-Fluorophenyl)-β,δdihydroxy-5-(1-methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1H-pyrrole-1- heptanoic Acid 1,1-Dimethylethyl Ester; Atorvastatin t-Butyl Ester; | 25MG,50MG | Freezer | 134395-00-9 | 614.76 | C37H43FN2O5 | NA | Atorvastatin Acid – In house impurity |
PA 01 83520 | Atorvastatin Epoxy Tetrahydrofuran Impurity | IH | 4-(4-Fluorophenyl)-2,4-dihydroxy-2-(1- methylethyl)-N,5-diphenyl-3,6- dioxabicyclo[3.1.0]hexane-1- carboxamide; Atorvastatin Epoxy THF Analog; | 25MG,50MG | Refrigerator | 873950-19-7 | 449.47 | C26H24FNO5 | Atorvastatin Photo Degradation Product ATV-FXA2; Dihydroxy Atorvastatin; Atorvastatin dihydroxy Diepoxide | Atorvastatin Acid – In house impurity |
PA 01 83530 | Atorvastatin 3-Deoxy-Hept-2-Enoic Acid Ethyl Ester | IH | (5S)-7-[2-(4-Fluorophenyl)-5-(1- methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1Hpyrrol-1-yl]-5-hydroxy-2-heptenoic Acid Ethyl Ester; | 25MG,50MG | NA | NA | 568.68 | C35H37FN2O4 | Atorvastatin Dehydro Ethyl Ester | Atorvastatin Acid – In house impurity |
PA 01 83540 | Atorvastatin 3-Deoxy-Hept-2-Enoic Acid Sodium Salt | IH | (S,E)-7-[2-(4-Fluorophenyl)-5- isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H- pyrrol-1- yl]-5-hydroxyhept-2-enoic acid sodium salt; | 25MG,50MG | NA | NA | 562.61 | C33H32FN2NaO4 | Atorvastatin Dehydro Acid Sodium Salt; | Atorvastatin Acid – In house impurity |
PA 01 83550 | 3-Dehydroxy 2,3-Dehydro Atorvastatin Lactone | IH | 1-[2-[(2S)-3,6-Dihydro-6-oxo-2H-pyran-2- yl]ethyl]-5-(4-fluorophenyl)-2-(1- methylethyl)-N,4-diphenyl-1H-pyrrole-3- carboxamide; | 25MG,50MG | Freezer | 442851-50-5 | 522.61 | C33H31FN2O3 | Atorvastatin Dehydro Lactone; Atorvastatin Eliminated Lactone; | Atorvastatin Acid – In house impurity |
PA 01 83560 | Atorvastatin Acetonide | IH | (4R,6R)-6-[2-[2-(4-Fluorophenyl)-5-(1- methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1H-pyrrol-1- yl]ethyl]-2,2-dimethyl-1,3-dioxane-4- acetic Acid; | 25MG,50MG | Refrigerator | 581772-29-4 | 598.7 | C36H39FN2O5 | NA | Atorvastatin Acid – In house impurity |
PA 01 83570 | Atorvastatin Sodium | IH | (3R,5R)-7-[3-(Phenylcarbamoyl)-5-(4- fluorophenyl)-2-isopropyl-4-phenyl-1Hpyrrol-1-yl]-3,5-dihydroxyheptanoic acid sodium salt; | 25MG,50MG | NA | 134523-01-6 | 580.62 | C33H34FN2NaO5 | NA | Atorvastatin Acid – In house impurity |
PA 01 83580 | Atorvastatin Calcium Salt | IH | (βR,δR)-2-(4-Fluorophenyl)-β,δdihydroxy-5-(1-methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1H-pyrrole-1- heptanoic Acid Calcium Salt; | 25MG,50MG | Freezer | 134523-03-8 | 1155.34 | C66H68CaF2N4O10 | Atorvastatin Hemicalcium; CI 981; Lipitor; Sortis; Tahor; YM 548; | Atorvastatin Acid – In house impurity |
PA 01 83590 | Atorvastatin Calcium Trihydrate | IH | Calcium bis{(3R,5R)-7-[3- (anilinocarbonyl)-5-(4-fluorophenyl)-2- isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5- dihydroxyheptanoate} trihydrate; | 25MG,50MG | NA | 344423-98-9 | 1209.39 | C66H74CaF2N4O13 | NA | Atorvastatin Acid – In house impurity |
PA 01 83600 | 5-Oxo Atorvastatin | IH | (γR)-2-(4-Fluorophenyl)-γ-hydroxy-5-(1- methylethyl)-δ-oxo-3-phenyl-4- [(phenylamino)carbonyl]-1H-pyrrole-1- heptanoic Acid; | 25MG,50MG | Hygroscopic , Freezer, Under Inert Atmosphere | 1391052-82-6 | 556.62 | C33H33FN2O5 | NA | Atorvastatin Acid – In house impurity |
PA 01 83610 | Atorvastatin 2-Hydroxy Sodium | IH | (3R,5R)-7-[3-(2- Hydroxyphenylcarbamoyl)-5-(4- fluorophenyl)-2-isopropyl-4- phenyl-1H-pyrrol-1-yl]-3,5- dihydroxyheptanoic Acid Sodium Salt; | 25MG,50MG | NA | 214217-86-4 | 596.62 | C33H34FN2NaO6 | 2-Hydroxy Atorvastatin Sodium; O-Hydroxy Atorvastatin Sodium; | Atorvastatin Acid – In house impurity |
PA 01 83620 | 4-Hydroxy Atorvastatin Calcium | IH | (βR,δR)-2-(4-Fluorophenyl)-β,δdihydroxy-4-[[(4- hydroxyphenyl)amino]carbonyl]-5-(1- methylethyl)-3-phenyl-1H-pyrrole-1- heptanoic Acid Calcium Salt; pHydroxyatorvastatin Calcium Salt; | 25MG,50MG | Hygroscopic , Freezer, Under Inert Atmosphere | NA | 612.7 | C33H33CaFN2O6 | NA | Atorvastatin Acid – In house impurity |
PA 01 83630 | 2-Hydroxy Atorvastatin Lactone | IH | 5-(4-Fluorophenyl)-N-(2-hydroxyphenyl)- 2-(1-methylethyl)-4-phenyl-1-[2-[(2R,4R)- tetrahydro-4-hydroxy-6-oxo-2H-pyran-2- yl]ethyl]-1H-pyrrole-3-carboxamide | 25MG,50MG | Hygroscopic , Freezer, Under Inert Atmosphere | 163217-74-1 | 556.62 | C33H33FN2O5 | Hydroxy Atorvastatin Lactone; Ortho-Hydroxy Atorvastatin Lactone; O-Hydroxy Atorvastatin Lactone; | Atorvastatin Acid – In house impurity |
PA 01 83640 | 4-Hydroxy Atorvastatin Lactone | IH | 5-(4-Fluorophenyl)-N-(4-hydroxyphenyl)- 2-(1-methylethyl)-4-phenyl-1-[2-[(2R,4R)- tetrahydro-4-hydroxy-6-oxo-2H-pyran-2- yl]ethyl]-1H-pyrrole-3-carboxamide; pHydroxy Atorvastatin Lactone; paraHydroxy Atorvastatin Lactone | 25MG,50MG | Freezer | 163217-70-7 | 556.62 | C33H33FN2O5 | NA | Atorvastatin Acid – In house impurity |
PA 01 83650 | Atorvastatin Ethyl Ester | IH | (βR,δR)-2-(4-Fluorophenyl)-β,δdihydroxy-5-(1-methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1H-pyrrole-1- heptanoic Acid Ethyl Ester; | 25MG,50MG | Freezer, Under Inert Atmosphere | 1146977-93-6 | 586.69 | C35H39FN2O5 | NA | Atorvastatin Acid – In house impurity |
PA 01 83660 | Methyl (3R,5R)-7-[2-(4-fluorophenyl)-3- phenyl-4-(phenylcarbamoyl)-5-(1- methylethyl)-1Hpyrrol- 1-yl]-3,5- dihydroxyheptanoate | Imp K | Atorvastatin Methyl Ester; (3R,5R)- Methyl 7-(2-(4-fluorophenyl)-5-isopropyl3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol1-yl)-3,5-dihydroxyheptanoate; | 25MG,50MG | Freezer | 345891-62-5 | 572.67 | C34H37FN2O5 | (βR,δR)-2-(4-Fluorophenyl)-β,δdihydroxy-5-(1-methylethyl)-3- phenyl-4-[(phenylamino)carbonyl]- 1H-pyrrole-1-heptanoic Acid Methyl Ester; | Atorvastatin Acid – Impurity K |
PA 01 83670 | Atorvastatin Cyclic Isopropyl Impurity | IH | Atorvastatin FP Impurity; 4-{6-(4- Fluorophenyl)-7,8-epoxy-6- hydroxy-8a-isopropyl-7-phenyl-8- (phenylcarbamoyl)hexahydro-2H – pyrrolo[2,1-b][1,3]oxazin-2-yl}-3- hydroxybutanoic Acid; Atorvastatin Cyclic 6-Hydroxy Impurity; | 25MG,50MG | NA | 873950-17-5 | 590.64 | C33H35FN2O7 | Atorvastatin Epoxy Pyrrolooxazin 6-Hydroxy Analog; Atorvastatin FXA Impurity; | Atorvastatin Acid – In house impurity |
PA 01 83680 | Atorvastatin Diepoxide Calcium Salt | IH | (βR,δR)-4-(4-Fluorophenyl)-β,δdihydroxy-6-(1-methylethyl)-2-phenyl-1- [(phenylamino)carbonyl]-3,7-dioxa-5- azatricyclo[4.1.0.02,4]heptane-5- heptanoic Acid Calcium Salt; | 25MG,50MG | NA | NA | 1219.34 | C66H68CaF2N4O14 | 7-[N-Phenyl-2-[4-(4-fluorophenyl]-6- methylethyl]-3,7-dioxa-5- azatricyclo[4.1.0.02,4]-4- [{phenylamino}carboxamiide]- (3R,5R)-3,5-dihydroxyheptanoic Acid Calcium Salt; | Atorvastatin Acid – In house impurity |
PA 01 83690 | Atorvastatin Cyclic Sodium Salt (Isopropyl) Impurity | IH | 4-{6-(4-Fluorophenyl)-7,8-epoxy-6- hydroxy-8a-isopropyl-7-phenyl-8- (phenylcarbamoyl)hexahydro-2H – pyrrolo[2,1-b][1,3]oxazin-2-yl}-3- hydroxybutanoic acid sodium salt; 7-(4- Fluorophenyl)hexahydro-β,7-dihydroxy1b-(1-methylethyl)-7a-phenyl-1a- [(phenylamino)carbonyl]-3Hoxireno[3,4]pyrrolo[2,1-b][1,3]oxazine-3- butanoic Acid Sodium Salt; |
25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphere | 1316291-19-6 | 612.62 | C33H34FN2NaO7 | Atorvastatin Cyclic 6-Hydroxy Impurity; Atorvastatin Epoxy Pyrrolooxazin Analog; Atorvastatin Cyclic Isopropyl Sodium Salt Impurity; ATV-cycloIP Sodium Salt; ATV-FXA Sodium Salt; Atorvastatin FXA Impurity Sodium Salt; | Atorvastatin Acid – In house impurity |
PA 01 83700 | Atorvastatin Epoxy Pyrrolooxazin Tricyclic Analog | IH | 2,6-(2-Carboxymethyl-3- oxapropano)-7,8-epoxy-8a-(4- fluorophenyl)-6-isopropyl-N,8- diphenylhexahydro-2H – pyrrolo[2,1-b][1,3]oxazine-7- carboxamide; | 25MG,50MG | NA | NA | 572.62 | C33H33FN2O6 | Atorvastatin Epoxy Pyrrolooxazin Tricyclic Analog; 2-(9-(4- Fluorophenyl)-1b-isopropyl9a-phenyl-1a- (phenylcarbamoyl)octahydro1aH-5,9- epoxyoxireno[2′,3′:3,4]pyrrol | Atorvastatin Acid – In house impurity |
PA 01 83710 | Atorvastatin Pyrrolidone Analog | IH | Atorvastatin Lactam Sodium Salt Impurity; (βR,δR)-5-(4-Fluorophenyl)-2,3- dihydro-β,δ-dihydroxy-3-(1-methylethyl)- 2-oxo-4-phenyl-3- [(phenylamino)carbonyl]-1H-pyrrole-1- heptanoic Acid Sodium Salt; | 25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphere | 148217-40-7 | 596.62 | C33H33FN2O6 | (3R,5R)-7-[5-(4-Fluorophenyl)-2,3- dihydro-3-(1-methylethyl)-2-oxo-4- phenyl-3-[(phenylamino)carbonyl]- 1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Sodium Salt; | Atorvastatin Acid – In house impurity |
PA 01 83720 | Dehydro Atorvastatin | IH | Atorvastatin 3-deoxyhept-2-enoic Acid; (S,E)-7-(2-(4-Fluorophenyl)-5-isopropyl-3- phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1- yl)-5-hydroxyhept-2-enoic Acid; (2E)-2,3- Dehydroxy Atorvastatin | 25MG,50MG | NA | 1105067-93-3 | 540.24 | C33H33FN2O4 | (2E,5S)-7-[2-(4-Fluorophenyl)-5-(1- methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1H-pyrrol1-yl]-5-hydroxy-2-heptenoic Acid | Atorvastatin Acid – In house impurity |
PA 01 83730 | (4S,cis)-1,1-Dimethylethyl-6-aminoethyl2,2-dimethyl-1,3-dioxane-4-acetate | IH | (4S,6S)-6-(2-Aminoethyl)-2,2-dimethyl1,3-dioxane-4-acetic Acid 1,1- Dimethylethyl Ester; [(4S,6S)-6-(2- Aminoethyl)-2,2-dimethyl[1,3]dioxan-4- yl]acetic Acid tert-Butyl Ester; | 25MG,50MG | Freezer, Under Inert Atmosphere | 947586-93-8 | 273.37 | C14H27NO4 | NA | Atorvastatin Acid – In house impurity |
PA 01 83740 | Atorvastatin Cyclic (Fluorophenyl) Sodium Salt Impurity | IH | 1b-(4-Fluorophenyl)hexahydro-β,7- dihydroxy-7-(1-methylethyl)-1a-phenyl-7a- [(phenylamino)carbonyl]-3Hoxireno[3,4]pyrrolo[2,1-b][1,3]oxazine-3- butanoic Acid Sodium; ATV-cycloFP Sodium; | 25MG,50MG | Freezer | 1315629-79-8 | 612.62 | C33H34FN2NaO7 | ATV-FX1 Sodium Salt; Atorvastatin FX1 Impurity; Atorvastatin Degradation Product – ATV-FX1; Atorvastatin Cyclic Fluorophenyl Impurity; Atorvastatin Cyclic 7-Hydroxy Impurity; | Atorvastatin Acid – In house impurity |
PA 01 83750 | (4R,cis)-1,1-Dimethylethyl-6-aminoethyl2,2-dimethyl-1,3-dioxane-4-acetate | IH | (4R,6R)-6-(2-Aminoethyl)-2,2-dimethyl1,3-dioxane-4-acetic Acid 1,1- Dimethylethyl Ester; [(4R,6R)-6-(2- Aminoethyl)-2,2-dimethyl[1,3]dioxan-4- yl]acetic Acid tert-Butyl Ester; | 25MG,50MG | Refrigerator | 125995-13-3 | 273.37 | C14H27NO4 | NA | Atorvastatin Acid – In house impurity |
PA 01 83760 | 2-(2-(2-(4-fluoro-phenyl)-2-oxo-1- phenyl-ethyl)-4-methyl-3-oxopentanoylamino)-3-phenylpropionic Acid Ethyl Ester | IH | Ethyl 2-(2-(2-(4-Fluorophenyl)-2- oxo-1-phenylethyl)-4-methyl-3- oxopentanamido)-3- phenylpropanoate | 25MG,50MG | NA | NA | 517.59 | C31H32FNO5 | NA | Atorvastatin Acid – In house impurity |
PA 01 83770 | Atorvastatin Pyrolidone Lactone | IH | Atorvastatin Pyrrolidone Lactone; Atorvastatin Lactam Lactone; 5- (4-Fluorophenyl)-1-{2-[(2R,4R)-4- hydroxy-6-oxotetrahydro-2Hpyran-2-yl]ethyl}-3-isopropyl-2- oxo-N,4-diphenyl-2,3-dihydro-1Hpyrrole-3-carboxamide | 25MG,50MG | NA | 906552-19-0 | 556.62 | C33H33FN2O5 | NA | Atorvastatin Acid – In house impurity |
PA 01 83780 | (3R,5S)-Atorvastatin Sodium Salt | IH | (βR,δS)-2-(4-Fluorophenyl)-β,δdihydroxy-5-(1-methylethyl)-3- phenyl-4-[(phenylamino)carbonyl]- 1H-pyrrole-1-heptanoic Acid Sodium Salt; | 25MG,50MG | Hygroscop ic, Freezer, Under Inert Atmosphe re | 131275-93-9 | 580.62 | C33H34FN2NaO5 | NA | Atorvastatin Acid – In house impurity |
PA 01 83790 | P-Hydroxy Atorvastatin | IH | 4-Hydroxy-Atorvastatin; (3R,5R)- 7-(2-(4-Fluorophenyl)-4-((4- hydroxyphenyl)carbamoyl)-5- isopropyl-3-phenyl-1H-pyrrol-1-yl)- 3,5-dihydroxyheptanoic Acid; | 25MG,50MG | NA | NA | 574.64 | C33H35FN2O6 | NA | Atorvastatin Acid – In house impurity |
PA 01 83800 | O-Hydroxy Atorvastatin | IH | 2-Hydroxy-Atorvastatin; (3R,5R)- 7-(2-(4-Fluorophenyl)-4-((2- hydroxyphenyl)carbamoyl)-5- isopropyl-3-phenyl-1H-pyrrol-1-yl)- 3,5-dihydroxyheptanoic Acid; | 25MG,50MG | NA | NA | 574.64 | C33H35FN2O6 | NA | Atorvastatin Acid – In house impurity |
PA 01 83810 | Atorvastatin Lactone Diepoxide | IH | 4-(4-Fluorophenyl)-6-(1- methylethyl)-N,2-diphenyl-5-[2- (tetrahydro-4-hydroxy-6-oxo-2Hpyran-2-yl)ethyl]-3,7-dioxa-5- azatricyclo[4.1.0.02,4]heptane-1- carboxamide | 25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphe re | 1046118-40-4 | 572.62 | C33H33FN2O6 | 4-(4-Fluorophenyl)-5-(2-(4- hydroxy-6-oxotetrahydro-2Hpyran-2-yl)ethyl)-6-isopropylN,2-diphenyl-3,7-dioxa-5- azatricyclo[4.1.0.02,4]hepta ne-1-carboxamide; | Atorvastatin Acid – In house impurity |
PA 28 37000 | Atosiban | API | 1-(3-Mercaptopropanoic Acid)-2- (O-ethyl-D-tyrosine)-4-Lthreonine-8-L-ornithineoxytocin, 1- Deamino-2-D-Tyr-(O-ethyl)-4-Thr8-ornoxytocin; Tractocile | 25MG,50MG | Freezer | 90779-69-4 | 994.19 | C43H67N11O12S2 | NA | Atosiban – API |
PA 28 37510 | Atosiban Acetate | IH | 1-(3-Mercaptopropanoic Acid)-2- (O-ethyl-D-tyrosine)-4-Lthreonine-8-L-ornithineoxytocin, 1- Deamino-2-D-Tyr-(O-ethyl)-4-Thr8-ornoxytocin Acetate; Antocile Acetate; Antocin Acetate; Antocin II Acetate; Tractocil Acetate; Tractocile Acetate; | 25MG,50MG | Refrigerator | 914453-95-5 | 1054.24 | C45H71N11O14S2 | Cyclic (1→5)-disulfide OEthyl-N-(3-mercapto-1- oxopropyl)-D-tyrosyl-Lisoleucyl-L-threonyl-Lasparaginyl-L-cysteinyl-Lprolyl-L-ornithyl-glycinamide Monoacetate; | Atosiban – In house impurity |
PA 28 01000 | Atovaquone | API | 2-[trans-4-(4-Chlorophenyl)cyclohexyl]-3- hydroxy-1,4-naphthalenedione | 25MG,50MG | Freezer | 95233-18-4 | 366.84 | C22H19ClO3 | 566C80; BW-566C; BW-566C-80; Mepron; Wellvone; | Atovaquone – API |
PA 28 01010 | Atovaquone Indene Isomer | Imp A | trans-2-[4-(4- Chlorophenyl)cyclohexyl]-1-oxo1H-indene-3-carboxylic Acid; 2- [trans-4-(4- Chlorophenyl)cyclohexyl]-1-oxo1H-indene-3- | 25MG,50MG | Refrigerator | NA | 366.84 | C22H19ClO3 | 2-((1r,4r)-4-(4- Chlorophenyl)cyclohexyl)-1- oxo-1H-indene-3-carboxylic Acid; | Atovaquone – Impurity A |
PA 28 01020 | cis-Atovaquone | Imp B | 2-[cis-4-(4- Chlorophenyl)cyclohexyl]-3- hydroxynaphthalene-1,4-dione; cis-2-[4-(4- Chlorophenyl)cyclohexyl]-3- hydroxy-1,4-naphthoquinone; | 25MG,50MG | NA | 137732-39-9 | 366.84 | C22H19ClO3 | cis-2-[4-(4- Chlorophenyl)cyclohexyl]-3- hydroxy-1,4- naphthalenedione; Atovaquone Related Compound A | Atovaquone – Impurity B |
PA 28 01030 | Didehydro Atovaquone | Imp C | 2-(4′-Chloro-2,3,4,5-tetrahydro-[1,1′- biphenyl]-4-yl)-3-hydroxynaphthalene-1,4- dione; (±)-Atovaquone Impurity C; | 25MG,50MG | NA | 1809464-27-4 | 364.82 | C22H17ClO3 | 2-(4′-Chloro-2,3,4,5-tetrahydro- [1,1′-biphenyl]-4-yl)-3- hydroxynaphthalene-1,4-dione; | Atovaquone – Impurity C |
PA 28 01510 | O-Methyl Atovaquone | IH | Trans-2-[4-(4-Chlorophenyl)cyclohexyl]-3- methoxy-1,4-naphthalenedione; 2- ((1r,4r)-4-(4-Chlorophenyl)cyclohexyl)-3- methoxynaphthalene-1,4-dione | 25MG,50MG | NA | 129700-41-0 | 380.86 | C23H21ClO3 | NA | Atovaquone – In house impurity |
PA 01 84000 | Atracurium Besylate | API | 2,2′-[1,5-Pentanediylbis[oxy(3-oxo-3,1- propanediyl)]]bis[1-[(3,4- dimethoxyphenyl)methyl]-1,2,3,4- tetrahydro-6,7-dimethoxy-2-methylisoquinolinium Benzenesulfonate | 25MG,50MG | Freezer | 64228-81-5 | 1243.48 | C65H82N2O18S2 | Atracurium Dibesylate; BW 33A; Tracrium; Tracur; Wellcome 33A74;2,2′-[1,5- Pentanediylbis[oxy(3-oxo-3,1- propanediyl)]]bis[1-[3,4- dimethoxyphenyl)methyl]-1,2,3,4- tetrahydro-6,7-dimethoxy-2- methylisoquinolinium]dibenzenesul fonate; | Atracurium Besylate – API |
PA 01 84010 | 1-(3,4-Dimethoxybenzyl)-2-[13-[1- (3,4-dimethoxybenzyl)-6,7- dimethoxy-3,4-dihydroisoquinolin2(1H)-yl]-3,11-dioxo-4,10- dioxatridecyl]-6,7-dimethoxy-2- methyl-1,2,3,4- tetrahydroisoquinolinium iodide | Imp A | 1-(3,4-Dimethoxybenzyl)-2-(3-((5- ((3-(1-(3,4-dimethoxybenzyl)-6,7- dimethoxy-3,4-dihydroisoquinolin2(1H)- yl)propanoyl)oxy)pentyl)oxy)-3- oxopropyl)-6,7-dimethoxy-2- methyl-1,2,3,4- | 25MG,50MG | Room Temp | NA | 1041.01 | C52H69IN2O12 | NA | Atracurium Besylate – Impurity A |
PA 01 84020 | Pentane-1,5-diyl bis[3-[1-(3,4- dimethoxybenzyl)-6,7-dimethoxy3,4-dihydroisoquinolin-2 (1H)- yl]propanoate] | Imp B | Pentane-1,5-diyl bis[3-[1-(3,4- dimethoxybenzyl)-6,7-dimethoxy3,4-dihydroisoquinolin-2 (1H)- yl]propanoate] | 25MG,50MG | Room Temp | NA | 899.08 | C51H66N2O12 | NA | Atracurium Besylate – Impurity B |
PA 01 84030 | 1-(3,4-Dimethoxybenzyl)-2-(3,11- dioxo-4,10-dioxatridec-12-enyl)- 6,7-dimethoxy-2-methyl- 1,2,3,4- tetrahydroisoquinolinium iodide | Imp c | 1-(3,4-Dimethoxybenzyl)-2-(3,11- dioxo-4,10-dioxatridec-12-enyl)- 6,7-dimethoxy-2-methyl- 1,2,3,4- tetrahydroisoquinolinium iodide (C1 = trans isomer, C2 = cis isomer | 25MG,50MG | Room Temp | NA | 697.6 | C32H44INO8 | NA | Atracurium Besylate – Impurity C |
PA 01 84040 | 1-(3,4-Dimethoxybenzyl)-2-[3-[(5- hydroxypentyl)oxy]-3-oxopropyl]- 6,7-dimethoxy-2- methyl-1,2,3,4- tetrahydroisoquinolinium iodide | Imp D | 1-(3,4-Dimethoxybenzyl)-2-(3-((5- hydroxypentyl)oxy)-3-oxopropyl)- 6,7-dimethoxy-2-methyl-1,2,3,4- tetrahydroisoquinolin-2-ium iodide (D1 = trans isomer, D2 = cis isomer) | 25MG,50MG | Room Temp | NA | 643.55 | C29H42INO7 | NA | Atracurium Besylate – Impurity D |
PA 01 84050 | 2-(2-Carboxyethyl)-1-(3,4- dimethoxybenzyl)-6,7-dimethoxy-2- methyl-1,2,3,4- tetrahydroisoquinolin-2-ium iodide | Imp E | 2-(2-Carboxyethyl)-1-(3,4- dimethoxybenzyl)-6,7-dimethoxy2-methyl-1,2,3,4- tetrahydroisoquinolin-2-ium iodide | 25MG,50MG | Room Temp | NA | 557.42 | C24H32INO6 | NA | Atracurium Besylate – Impurity E |
PA 01 84060 | 1-(3,4-Dimethoxybenzyl)-6,7- dimethoxy-2,2-dimethyl-1,2,3,4- tetrahydroisoquinolinium iodide | Imp F | 1-(3,4-Dimethoxybenzyl)-6,7- dimethoxy-2,2-dimethyl-1,2,3,4- tetrahydroisoquinolin-2-ium iodide; | 25MG,50MG | Room Temp | NA | 499.38 | C22H30INO4 | NA | Atracurium Besylate – Impurity F |
PA 01 84070 | 1-(3,4-Dimethoxybenzyl)-6,7- dimethoxy-2-methyl-1,2,3,4- tetrahydroisoquinoline | Imp G | 1-(3,4-Dimethoxybenzyl)-6,7- dimethoxy-2-methyl-1,2,3,4- tetrahydroisoquinoline; | 25MG,50MG | Room Temp | NA | 357.44 | C21H27NO4 | NA | Atracurium Besylate – Impurity G |
PA 01 84080 | 2,2′-[Hexane-1,6-diylbis[oxy(3- oxopropane-1,3-diyl)]]bis[1-(3,4- dimethoxybenzyl)-6,7-dimethoxy-2- methyl-1,2,3,4- tetrahydroisoquinolinium] diiodide | Imp H | 2,2′-((Hexane-1,6- diylbis(oxy))bis(3-oxopropane-3,1- diyl))bis(1-(3,4-dimethoxybenzyl)- 6,7-dimethoxy-2-methyl-1,2,3,4- tetrahydroisoquinolin-2-ium) diiodide (H1 = cis-trans isomer, H2 = cis-cis isomer); | 25MG,50MG | Room Temp | NA | 1196.98 | C54H74I2N2O12 | NA | Atracurium Besylate – Impurity H |
PA 01 84090 | 2,2′-[(3-Methylpentane-1,5)- diylbis[oxy(3-oxopropane-1,3- diyl)]]bis[1-(3,4- dimethoxybenzyl)- 6,7-dimethoxy-2-methyl-1,2,3,4- tetrahydroisoquinolinium] diiodide | Imp I | 2,2′-(((3-Methylpentane-1,5- diyl)bis(oxy))bis(3-oxopropane3,1-diyl))bis(1-(3,4- dimethoxybenzyl)-6,7-dimethoxy2-methyl-1,2,3,4- tetrahydroisoquinolin-2-ium) | 25MG,50MG | Room Temp | NA | 1196.98 | C54H74I2N2O12 | NA | Atracurium Besylate – Impurity I |
PA 01 84100 | Methyl Benzenesulfonate | Imp J | Benzenesulfonic Acid Methyl Ester; Methyl Besylate; NSC 3214; 20ND3-5; | 25MG,50MG | Refrigerator | 80-18-2 | 172.2 | C7H8O3S | NA | Atracurium Besylate – Impurity J |
PA 01 84110 | 2,2′-[(hexane-1,5)-diylbis[oxy(3- oxopropane-1,3-diyl)]]bis[1-(3,4- dimethoxybenzyl)-6,7-dimethoxy-2- methyl-1,2,3,4- tetrahydroisoquinolinium] diiodide | Imp K | 2,2′-[(hexane-1,5)-diylbis[oxy(3- oxopropane-1,3-diyl)]]bis[1-(3,4- dimethoxybenzyl)-6,7-dimethoxy2-methyl-1,2,3,4- tetrahydroisoquinolinium] diiodide; | 25MG,50MG | Room Temp | NA | 1196.98 | C54H74I2N2O12 | NA | Atracurium Besylate – Impurity K |
PA 01 85000 | Atropine | API | (RS)-(8-methyl-8-azabicyclo[3.2.1]oct-3- yl) 3-hydroxy-2-phenylpropanoate | 25MG,50MG | NA | 51-55-8 | 289.37 | C17H23NO3 | NA | Atropine – API |
PA 01 85030 | (2RS)-3-Hydroxy-2-phenylpropanoic Acid | Imp C | α-(Hydroxymethyl)-benzeneacetic Acid; (±)-Tropic Acid; (±)-2-Phenyl-3- hydroxypropionic Acid; Tropic Acid; | 25MG,50MG | Room Temp | 529-64-6 | 166.17 | C9H10O3 | (±)-3-Hydroxy-2-phenylpropionic Acid; 2-Phenyl-3-hydroxypropanoic Acid; 2-Phenyl-3-hydroxypropionic Acid; 2-Phenylhydracrylic Acid; 3- Hydroxy-2-phenylpropionic Acid; DL-Tropic Acid; NSC 20990; | Atropine – Impurity C |
PA 01 85040 | 6-hydroxyhyoscyamine | Imp D | 6(S)-Hydroxyhyoscyamine; (-)- (3S,6S,2’S)-6β-Hydroxyhyoscyamine; (-)- 6β-Hydroxyhyoscyamine; 6βHydroxyhyoscyamine; Anisodamine | 25MG,50MG | NA | 55869-99-3 | 305.37 | C17H23NO4 | [1R-[1α,3β(S*),5α,6α]]α- (hydroxymethyl)benzeneacetic Acid 6-Hydroxy-8-methyl-8- azabicyclo[3.2.1]oct-3-yl Ester; | Atropine – Impurity D |
PA 01 85510 | Atropic Acid | IH | α-Methylenebenzeneacetic Acid; 2- Phenylacrylic Acid |
25MG,50MG | Refrigerator | 492-38-6 | 148.16 | C9H8O2 | 2-Phenylprop-2-enoic Acid; 2- Phenyl-2-propenoic Acid; NSC 20987; α-Phenylacrylic Acid; | Atropine – In house impurity |
PA 01 85520 | Atropine Sulfate Monohydrate | IH | α-(Hydroxymethyl)benzeneacetic Acid (3- endo)-8-Methyl-8-azabicyclo[3.2.1]oct-3- yl Ester Sulfate Hydrate | 25MG,50MG | Refrigerator | 5908-99-6 | 694.83 | C34H50N2O11S | Atropine Sulfate Hydrate; Atropisol; Atropt; | Atropine – In house impurity |
PA 28 48000 | Aureofungin | API | (19E,21E,23Z,25E,27E,29E,31E)- 33-(((3S,4S,5S,6R)-4-Amino-3,5- dihydroxy-6-methyltetrahydro-2Hpyran-2-yl)oxy)- 1,3,5,7,9,11,13,37-octahydroxy17-(5-hydroxy-7-(4- (methylamino)phenyl)-7- oxoheptan-2-yl)-18-methyl-15- oxo-16,39- dioxabicyclo[33.3.1]nonatriaconta19,21,23,25,27,29,31-heptaene36-carboxylic Acid |
25MG,50MG | NA | 8065-41-6 | 1129.33 | C59H88N2O19 | NA | Aureofungin – API |
PA 28 44000 | Avanafil | API | (S)-2-(2-Hydroxymethyl-1- pyrrolidinyl)-4-(3-chloro-4- methoxybenzylamino)-5-[(2- pyrimidinylmethyl)carbamoyl]pyri midine; 4-[[(3-Chloro-4- methoxyphenyl)methyl]amino]-2- [(2S)-2-(hydroxymethyl)-1- pyrrolidinyl]-N-(2- | 25MG,50MG | Refrigerator | 330784-47-9 | 483.95 | C23H26ClN7O3 | NA | Avanafil – API |
PA 01 86000 | Avobenzone | API | 1-[4-(1,1-Dimethylethyl)phenyl]-3- (4-methoxyphenyl)-1,3- propanedione; | 25MG,50MG | Refrigerator | 70356-09-1 | 310.39 | C20H22O3 | 1-(4-tert-Butylphenyl)-3-(4- methoxyphenyl)propane-1,3- dione; Butylmethoxydibenzoylmeth ane; Escalol 517; Eusolex 9020; | Avobenzone – API |
PA 28 45000 | Axitinib | API | N-Methyl-2-[[3-[(1E)-2-(2- pyridinyl)ethenyl]-1H-indazol-6- yl]thio]benzamide; (E)-N-methyl-2- ((3-(2-(pyridin-2-yl)vinyl)-1Hindazol-6-yl)thio)benzamide | 25MG,50MG | Freezer | 319460-85-0 | 386.47 | C22H18N4OS | NA | Axitinib – API |
PA 28 20000 | Azacitidine | API | 5-Azacytidine; 4-Amino-1-β-Dribofuranosyl-1,3,5-triazin-2(1H)-one; 5- AC; 5-AZC; 5-AZCR; 5-AzaC; | 25MG,50MG | Hygroscopic, Freezer, Under inert atmosphere | 320-67-2 | 244.2 | C8H12N4O5 | Antibiotic U 18496; Azacytidine; Ladakamycin; Ledakamycin; Mylosar; NSC 102816; NSC 103- 627; U 18496; Vidaza; WR 183027; | Azacitidine – API |
PA 28 20510 | N-(Formylamidino)-N’-beta-Dribofuranosylurea | IH | Azacitidine Formyl Amidine Analog; N-((Z)-N’- (((2R,3R,4S,5R)-3,4-dihydroxy-5- (hydroxymethyl)tetrahydrofuran-2- yl)carbamoyl)carbamimidoyl)form amide | 25MG,50MG | NA | 65126-88-7 | 262.22 | C8H14N4O6 | N-(Formyl amidino)-N-β-Dribofuranosylurea; N-(Formyl amidino)-N-β-Dribofuranosylurea; N- (Formylamidino)-N’-β-Dribofuranosylurea; N-{[(Z)- Amino(formamido)methylen e]carbamoyl}-β-D | Azacitidine – In house impurity |
PA 28 20520 | 5-Azacytosine | IH | 5-Aza Cytosine; 4-Amino-s-triazin-2(1H)- one; 6-Amino-1,3,5-triazin-2(1H)-one | 25MG,50MG | Freezer | 931-86-2 | 112.09 | C3H4N4O | 4-Amino-s-triazin-2-ol; NSC 51100; NSC 54006; Azacitidine Related Compound A; | Azacitidine – In house impurity |
PA 28 20530 | 2-Acetyl Azacitidine | IH | Monoacyl Azacitidine; ((2R,3S,4R,5R)-5-(4-Amino-2-oxo1,3,5-triazin-1(2H)-yl)-3,4- dihydroxytetrahydrofuran-2- yl)methyl Acetate | 25MG,50MG | NA | NA | 286.24 | C13H17N7O12 | NA | Azacitidine – In house impurity |
PA 28 20540 | 2′,3′,5′-Triacetyl-5-Azacytidine | IH | 4-Amino-1-(2,3,5-tri-O-acetyl-β-Dribofuranosyl)-1,3,5-triazin-2(1H)-one; (2R,3R,4R,5R)-2-(Acetoxymethyl)-5-(4- amino-2-oxo-1,3,5-triazin-1(2H)- yl)tetrahydrofuran-3,4-diyl Diacetate; | 25MG,50MG | NA | 10302-78-0 | 370.31 | C13H17N7O12 | NA | Azacitidine – In house impurity |
PA 28 20550 | 1-β-D-Ribofuranosyl-3-guanylurea Picrate | IH | 1-Amidino-3-β-Dribofuranosylurea Monopicrate; 1- beta-D-Ribofuranosyl-3- guanylurea Picrate | 25MG,50MG | NA | 4336-46-3 | 463.31 | C13H17N7O12 | Azacitidine Related Compound C; | Azacitidine – In house impurity |
PA 28 31000 | Azatadine | API | 11-(1-Methylpiperidin-4-ylidene)-6,11- dihydro-5H-benzo[5,6]cyclohepta[1,2- b]pyridine | 25MG,50MG | NA | 3964-81-6 | 290.4 | C20H22N2 | 5H-Benzo[5,6]cyclohepta[1,2- b]pyridine, 6,11-dihydro-11-(1- methyl-4-piperidinylidene)-; | Azatadine – API |
PA 28 29000 | Azathioprine | API | 6-(1-Methyl-4-nitroimidazol-5- yl)thiopurine; 6-[(1-Methyl-4-nitro-1Himidazol-5-yl)sulfanyl]-7H-purine; Imurek; Imurel; Zytrim | 25MG,50MG | Freezer | 446-86-6 | 277.26 | C9H7N7O2S | 6-[(1-Methyl-4-nitro-1H-imidazol-5- yl)thio]-1H-purine; BW-57-322; NSC-39084; Azanin; Imuran; | Azathioprine – API |
PA 28 29010 | 1-Methyl-4-nitro-1H-imidazol-5-amine | imp A | 5-Amino-1-methyl-4-nitroimidazole; 5- Amino-1-methyl-4-nitro-imidazole; NSC 400013 | 25MG,50MG | NA | 4531-54-8 | 142.18 | C4H6N4O2 | Azathioprine Related Compound A; | Azathioprine – Impurity A |
PA 28 29020 | Mercaptopurine | Imp B | 7H-Purine-6-thiol; 6-Purinethiol; 6- Thiohypoxanthine; 6-Mercaptopurine | 25MG,50MG | Refrigerator | 50-44-2 | 152.18 | C5H4N4S | NA | Azathioprine – Impurity B |
PA 28 29040 | 1-Methyl-4-nitro-5-thioimidazole | Imp D | 1-Methyl-4-nitro-1H-imidazole-5- thiol; 1-Methyl-4-nitro-imidazole-5- thiol; 5-Mercapto-1-methyl-4- nitroimidazole | 25MG,50MG | Hygroscop ic, Freezer, Under inert | 6339-54-4 | 159.17 | C4H5N3O2S | NA | Azathioprine – Impurity D |
PA 28 29050 | 1-Methyl-4-nitro-1H-imidazol-5-ol | Imp E | 5-Hydroxy-1-methyl-4- nitroimidazole | 25MG,50MG | NA | 73703-74-9 | 143.1 | C4H5N3O3 | NA | Azathioprine – Impurity E |
PA 28 29060 | Hypoxanthine | Imp F | 1,7-Dihydro-6H-purin-6-one; 1HPurin-6(7H)-one; Sarkin; Sarkine | 25MG,50MG | Freezer | 68-94-0 | 136.11 | C5H4N4O | NA | Azathioprine – Impurity F |
PA 28 29070 | Thiamiprine | Imp G | 6-[(1-Methyl-4-nitro-1H-imidazol-5- yl)sulfanyl]-7H-purin-2-amine; 6-[(1- Methyl-4-nitro-1H-imidazol-5-yl)thio]-9Hpurin-2-amine; Tiamiprin; Tiamiprine; | 25MG,50MG | Amber Vial, Freezer, Under inert atmosphere | 5581-52-2 | 292.98 | C9H8N8O2S | 6-[(1-Methyl-4-nitro-1H-imidazol-5- yl)thio]-1H-purin-2-amine; 2-Amino6-[(1-methyl-4-nitroimidazol-5- yl)thio]purine; Aminoazathioprin; BW 57-323; Guaneran; ITG; NSC 38887; Azathioprine Related Compound G; |
Azathioprine – Impurity G |
PA 01 87000 | Azelaic Acid | API | Nonanedioic Acid; Azelate; Nonanedioate; | 25MG,50MG | Refrigerator | 123-99-9 | 188.22 | C9H16O4 | NA | Azelaic Acid – API |
PA 01 98000 | Azelastine Hydrochloride | API | 4-[(4-chlorophenyl)methyl]-2-(1- methylazepan-4-yl)phthalazin-1-one hydrochloride | 25MG,50MG | NA | 79307-93-0 | 418.36 | C23H24Cl2N3O | Astelin; Optivar; | Azelastine – API |
PA 01 98010 | Benzoyl Hydrazine | Imp A | Benzoic Acid Hydrazide; 4-Benzoic Hydrazide; Benzenecarboxylic Acid Hydrazide; Benzhydrazide; Benzohydrazide | 25MG,50MG | Room Temp | 613-94-5 | 136.15 | C7H8N2O | Benzoic Hydrazide; Benzoylhydrazine; INHd 14; NBenzoylhydrazine; NSC 644; | Azelastine – Impurity A |
PA 01 98030 | 2-[(4-Chlorophenyl)acetyl]benzoic Acid | Imp C | 2-[2-(4-Chlorophenyl)acetyl]benzoic Acid; | 25MG,50MG | Room Temp | 53242-76-5 | 274.7 | C15H11ClO3 | NA | Azelastine – Impurity C |
PA 01 88000 | Azithromycin | API | (2R,3S,4R,5R,8R,10R,11R,12S,13S,14 R)-2-ethyl-3,4,10-trihydroxy3,5,6,8,10,12,14-heptamethyl-15-oxo- 11- {[3,4,6-trideoxy-3-(dimethylamino)-β-Dxylo-hexopyranosyl]oxy}-1-oxa-6- azacyclopentadec-13-yl 2,6-dideoxy-3-Cmethyl-3-O-methyl-α-L-ribohexopyranoside | 25MG,50MG | NA | 83905-01-5 | 748.98 | C38H72N2O12 | (2R,3S,4R,5R,8R,10R,11R,12S,13 S,14R)-11-(((2S,3R,4S,6R)-4- (Dimethylamino)-3-hydroxy-6- methyltetrahydro-2H-pyran-2- yl)oxy)-2-ethyl-3,4,10-trihydroxy-13- (((2R,4R,5S,6S)-5-hydroxy-4- methoxy-4,6-dimethyltetrahydro2H-pyran-2-yl)oxy)- 3,5,6,8,10,12,14-heptamethyl-1- oxa-6-azacyclopentadecan-15- one; |
Azithromycin – API |
PA 01 88010 | 6-demethylazithromycin | Imp A | Azaerythromycin A; Azathramycin; Desmethylazithromycin | 25MG,50MG | Freezer | 76801-85-9 | 734.96 | C37H70N2O12 | 9-Deoxo-9a-aza-9a-homo Erythromycin A; Desmethyl Azithromycin; | Azithromycin – Impurity A |
PA 01 88020 | 3-Deoxyazithromycin | Imp B | Azithromycin B; 3-Deshydroxy Azithromycin; (2R,3R,4R,5R,8R,10R,11R,12R,13S,14 R)-13-[(2,6-Dideoxy-3-C-methyl-3-Omethyl-α-L-ribo-hexopyranosyl)oxy]-2- ethyl-4,10-dihydroxy-3,5,6,8,10,12,14- heptamethyl-11-[[3,4,6-trideoxy-3- (dimethylamino)-β-D-xylohexopyranosyl]oxy]-1-Oxa-6- azacyclopentadecan-15-one |
25MG,50MG | Freezer | 307974-61-4 | 733 | C38H72N2O11 | NA | Azithromycin – Impurity B |
PA 01 88030 | 3′-O-demethylazithromycin | Imp C | Azithromycin C | 25MG,50MG | NA | NA | 734.98 | C37H70N2O12 | NA | Azithromycin – Impurity C |
PA 01 88040 | 14-demethyl-14- (hydroxymethyl)azithromycin | Imp D | 14-demethyl-14- (hydroxymethyl)azithromycin; Azithromycin F | 25MG,50MG | NA | NA | 765 | C38H72N2O13 | NA | Azithromycin – Impurity D |
PA 01 88050 | 3’-N,N-Di(desmethyl) Azithromycin | Imp E | (2R,3S,4R,5R,8R,10R,11R,12S,13S,14 R)-11-[(3-Amino-3,4,6-trideoxy-β-D-xylohexopyranosyl)oxy]-13-[(2,6-dideoxy-3-Cmethyl-3-O-methyl-α-L-ribohexopyranosyl)oxy]-2-ethyl-3,4,10- trihydroxy-3,5,6,8,10,12,14-heptamethyl1-oxa-6-azacyclopentadecan-15-one; Aminoazithromycin | 25MG,50MG | NA | 612069-27-9 | 720.93 | C36H68N2O12 | Aminoazithromycin A; | Azithromycin – Impurity E |
PA 01 88060 | 3′-N-demethyl-3′-N-formylazithromycin | Imp F | (2R,3S,4R,5R,8R,10R,11R,12S,13S,14 R)-13-[(2,6-Dideoxy-3-C-methyl-3-Omethyl-α-ribo-hexopyranosyl)oxy]-2-ethyl3,4,10-trihydroxy-3,5,6,8,10,12,14- heptamethyl-11-[[3,4,6-trideoxy-3- (formylmethylamino)-β-D-xylohexopyranosyl]oxy]-1-oxa-6- azacyclopentadecan-15-one | 25MG,50MG | NA | 612069-28-0 | 762.97 | C38H70N2O13 | Azithromycin Related Compound F; | Azithromycin – Impurity F |
PA 01 88070 | 3′-N-demethyl-3′-N-[(4- methylphonyl)sulphonyl]azithromycin | Imp G | (2R,3S,4R,5R,8R,10R,11R,12S,13S,14 R)-13-[(2,6-Dideoxy-3-C-methyl-3-Omethyl -α-L-ribo-hexopyranosyl)oxy]-2- ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14- heptamethyl-11-[[3,4,6-trideoxy-3- [methyl[(4-methylphenyl)sulfonyl]amino]- β-D-xylo-hexopyranosyl]oxy]-1-oxa-6- azacyclopentadecan-15-one |
25MG,50MG | Freezer | 612069-31-5 | 889.14 | C44H76N2O14S | NA | Azithromycin – Impurity G |
PA 01 88080 | 3′-N-[[4-(acetylamino)phenyl]sulphonyl]3′- N-demethylazithromycin | Imp H | (2R,3S,4R,5R,8R,10R,11R,12S,13S,14 R)-11-[[3-[[[4- (Acetylamino)phenyl]sulfonyl]methylamin o]-3,4,6-trideoxy-β-D-xylohexopyranosyl]oxy]-13-[(2,6-dideoxy-3-Cmethyl-3-O-methyl-α-L-ribohexopyranosyl)oxy]-2-ethyl-3,4,10- trihydroxy-3,5,6,8,10,12,14-heptamethyl1-oxa-6-azacyclopentadecan-15-one |
25MG,50MG | NA | 612069-30-4 | 932.17 | C45H77N3O15S | Azithromycin Related Impurity H | Azithromycin – Impurity H |
PA 01 88090 | 3′-N-demethylazithromycin | Imp I | (2R,3S,4R,5R,8R,10R,11R,12S,13S,14 R)-13-[(2,6-dideoxy-3-C-methyl-3-Omethyl-α-L-ribo-hexopyranosyl)oxy]-2- ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14- heptamethyl-11-[[3,4,6-trideoxy-3- (methylamino)-β-D-xylohexopyranosyl]oxy]-1-oxa-6- azacyclopentadecan-15-one; CP-64434 | 25MG,50MG | Hygroscopic, Freezer, Under inert atmosphere | 172617-84-4 | 734.96 | C37H70N2O12 | NA | Azithromycin – Impurity I |
PA 01 88100 | Descladinose Azithromycin | Imp J | (2R,3S,4R,5R,8R,10R,11R,12S,13S,14 R)-2-Ethyl-3,4,10,13-tetrahydroxy3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6- trideoxy-3-(dimethylamino)-β-D-xylohexopyranosyl]oxy]-1-oxa-6- azacyclopentadecan-15-one; Decladinosylazithromycin | 25MG,50MG | Freezer, Under Inert Atmosphere | 117693-41-1 | 590.79 | C30H58N2O9 | 13-O-decladinosylazithromycin; CP 66458; Desosaminylazithromycin; | Azithromycin – Impurity J |
PA 01 88110 | C14,1″-epoxyazithromycin | Imp K | C14,1″-epoxyazithromycin; Azithromycin E; C14,1′′- epoxyazithromycin | 25MG,50MG | NA | NA | 762.99 | C38H70N2O13 | NA | Azithromycin – Impurity K |
PA 01 88120 | Azithromycin N-Oxide | Imp L | (2R,3S,4R,5R,8R,10R,11R,12S,13S,14 R)-13-[(2,6-Dideoxy-3-C-methyl-3-Omethyl-α-L-ribo-hexopyranosyl)oxy]-2- ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14- heptamethyl-11-[[3,4,6-trideoxy-3- (dimethyloxidoamino)-β-D-xylohexopyranosyl]oxy]-1-oxa-6- azacyclopentadecan-15-one | 25MG,50MG | Freezer | 90503-06-3 | 764.98 | C38H72N2O13 | azithromycin 3′-N-oxide; | Azithromycin – Impurity L |
PA 01 88130 | 3’-N,N-Di(desmethyl)-3’-N-formyl Azithromycin | Imp M | (2R,3S,4R,5R,8R,10R,11R,12S,13S,14 R)-13-[(2,6-Dideoxy-3-C-methyl-3-Omethyl-α-L-ribo-hexopyranosyl)oxy]-2- ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14- heptamethyl-11-[[3,4,6-trideoxy-3- (formylamino)-β-D-xylohexopyranosyl]oxy]-1-oxa-6- azacyclopentadecan-15-one | 25MG,50MG | NA | 765927-71-7 | 748.94 | C37H68N2O13 | 3′-(N,N-didemethyl)-3′-Nformylazithromycin; | Azithromycin – Impurity M |
PA 01 88140 | 3’-De(dimethylamino)-3’-oxoazithromycin | Imp N | 3’-Des(dimethylamino)-3’-keto Azithromycin; (2R,3S,4R,5R,8R,10R,11R,12S,13S,14 R)-11-[[4,6-dideoxy-β-D-erythrohexopyranos-3-ulos-1-yl]oxy]-13-[(2,6- dideoxy-3-C-methyl-3-O-methyl-α-L-ribohexopyranosyl)oxy]-2-ethyl-3,4,10- trihydroxy-3,5,6,8,10,12,14-heptamethyl1-oxa-6-azacyclopentadecan-15-one |
25MG,50MG | NA | 612069-25-7 | 748.94 | C36H65NO13 | NA | Azithromycin – Impurity N |
PA 01 88150 | 2-desethyl-2-propylazithromycin | Imp O | 1-Oxa-6-azacyclopentadecan-15- one, 13-[(2,6-dideoxy-3-C-methyl3-O-methyl-α-L-ribohexopyranosyl)oxy]-3,4,10- trihydroxy-3,5,6,8,10,12,14- heptamethyl-2-propyl-11-[[3,4,6- trideoxy-3-(dimethylamino)-β-Dxylo-hexopyranosyl]oxy]-, (2R,3S,4R,5R,8R,10R,11R,12S,1 | 25MG,50MG | NA | NA | 763.03 | C39H74N2O12 | NA | Azithromycin – Impurity O |
PA 28 10000 | Azithromycin Dihydrate | API | (2R,3S,4R,5R,8R,10R,11R,12S,13S,14 R)-13-[(2,6-Dideoxy-3-C-methyl-3-Omethyl-α-L-ribo-hexopyranosyl)oxy]-2- ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14- heptamethyl-11-[[3,4,6-trideoxy-3- (dimethylamino)-β-D-xylohexopyranosyl]oxy]-1-oxa-6- azacyclopentadecan-15-one Dihydrate | 25MG,50MG | Freezer, Under inert atmosphere | 117772-70-0 | 785.02 | C38H76N2O14 | CP-62993; XZ-450; Azitrocin; Ribotrex; Sumamed; Trozocina; Zithromaz; Zitromax; | Azithromycin Dihydrate – API |
PA 01 89000 | Aztreonam | API | [2S-[2α,3β(Z)]]-2-[[(Z)-[1-(2-Amino-4- thiazolyl)-2-[[(2S,3S)-2-methyl-4-oxo-1- sulfo-3-azetidinyl]amino]-2- oxoethylidene]amino]oxy]-2- methylpropanoic Acid | 25MG,50MG | Freezer | 78110-38-0 | 435.43 | C13H17N5O8S2 | Azthreonam; Aztreon; Monobactam; Nebactam;SQ 26776; Squibb 26776; | Aztreonam – API |
PA 01 89510 | Aztreonam Disodium | IH | Disodium 2-[[1-(2-amino-1,3- thiazol-4-yl)-2-[[(2S,3S)-2-methyl4-oxo-1-sulfoazetidin-3-yl]amino]- 2-oxoethylidene]amino]oxy-2- methylpropanoic Acid | 25MG,50MG | NA | 80581-86-8 | 481.41 | C13H17N5Na2O8S2 | (Z)-2-[[[(2-Amino-4- thiazolyl)[[(2S,3S)-2-methyl4-oxo-1-sulfo-3- azetidinyl]carbamoyl]methyl ene]amino]oxy]-2- methylpropionic acid Disodium Salt; | Aztreonam – In house impurity |
PA 01 89520 | Aztreonam E-Isomer | IH | (E)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2- methyl-4-oxo-1-sulfo-3- azetidinyl]carbamoyl]methylene]amino]o xy]-2-methylpropionic Acid; (E)- Aztreonam | 25MG,50MG | NA | 99341-02-3 | 435.43 | C13H17N5O8S2 | 2-[[(E)-[1-(2-Amino-4-thiazolyl)-2- [[(2S,3S)-2-methyl-4-oxo-1-sulfo-3- azetidinyl]amino]-2- oxoethylidene]amino]oxy]-2-methylpropanoic Acid; SQ 28429 | Aztreonam – In house impurity |
PA 02 01000 | Baccatin III | API | (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS )-6,12b-Bis(acetyloxy)-12-(benzoyloxy)- 1,2a,3,4,4a,6,9,10,11,12,12a,12bdodecahydro-4,9,11-trihydroxy4a,8,13,13-tetramethyl-7,11-methano-5Hcyclodeca[3,4]benz[1,2-b]oxet-5-one | 25MG,50MG | Freezer | 27548-93-2 | 586.63 | C31H38O11 | NSC 330753 | Baccatin III – API |
PA 02 01510 | 7,13-Bis-O-(triethylsilyl) Baccatin III | IH | (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS )-6,12b-Bis(acetyloxy)-12-(benzoyloxy)- 1,2a,3,4,4a,6,9,10,11,12,12a,12bdodecahydro-11-hydroxy-4a,8,13,13- tetramethyl-4,9-bis[(triethylsilyl)oxy]-7,11- methano-5H-cyclodeca[3,4]benz[1,2- b]oxet-5-one | 25MG,50MG | NA | 150541-99-4 | 815.15 | C43H66O11Si2 | 7,13-Bis(triethylsilyl)baccatin III; | Baccatin III – In house impurity |
PA 02 01520 | 7-epi-10-Deacetyl Baccatin III | IH | (2aR,4R,4aS,6R,9S,11S,12S,12aR,12b S)-12b-(Acetyloxy)-12-(benzoyloxy)- 1,2a,3,4,4a,6,9,10,11,12,12a,12bdodecahydro-4,6,9,11-tetrahydroxy4a,8,13,13-tetramethyl-7,11-methano-5Hcyclodeca[3,4]benz[1,2-b]oxet-5-one | 25MG,50MG | Freezer | 71629-92-0 | 544.59 | C29H36O10 | 10-Deacetylbaccatin V; 7-Epi-10- deacetylbaccatin III; 7-epi-10-DAB; | Baccatin III – In house impurity |
PA 02 01530 | 13-epi-10-Deacetyl Baccatin III | IH | [2aR- (2aα,4β,4aβ,6β,9β,11α,12α,12aα,12bα)]- 12b-(Acetyloxy)-12-(benzoyloxy)- 1,2a,3,4,4a,6,9,10,11,12,12a,12bdodecahydro-4,6,9,11-tetrahydroxy4a,8,13,13-tetramethyl-7,11-methano-5Hcyclodeca[3,4]benz[1,2-b]oxet-5-one | 25MG,50MG | NA | 172018-16-5 | 544.59 | C29H36O10 | 13-epi-10-DAB; (-)-10-Deacetyl13-epibaccatin III; 13-Epi-10- deacetylbaccatin III; | Baccatin III – In house impurity |
PA 02 01540 | 2-Debenzoyl-2-tigloyl 10-Deacetyl Baccatin III | IH | (2E)-2-Methyl-2-butenoic Acid (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS )- 12b-(acetyloxy)- 2a,3,4,4a,5,6,9,10,11,12,12a,12bdodecahydro-4,6,9,11-tetrahydroxy4a,8,13,13-tetramethyl-5-oxo-7,11- methano-1H-cyclodeca[3,4]benz[1,2- b]oxet-12-yl Ester; 2-Debenzoyl-2-tigloyl 10-DAB | 25MG,50MG | Amber Vial, Freezer | 171926-87-7 | 522.58 | C27H38O10 | NA | Baccatin III – In house impurity |
PA 02 01550 | 13-epi-14β-Hydroxy-10-deacetyl Baccatin III | IH | (2aR,4S,4aS,6R,9S,10S,11R,12S,12aR, 12bS)-12b-(Acetyloxy)-12-(benzoyloxy)- 1,2a,3,4,4a,6,9,10,11,12,12a,12bdodecahydro-4,6,9,10,11-pentahydroxy4a,8,13,13-tetramethyl-7,11-methano-5Hcyclodeca[3,4]benz[1,2-b]oxet-5-one | 25MG,50MG | Refrigerator, under inert atmosphere | NA | 560.59 | C29H36O11 | 14β-Hydroxy 10-Deacetyl Baccatin III; | Baccatin III – In house impurity |
PA 02 01560 | 7-epi-10-Oxo-10-deacetyl Baccatin III | IH | (2aR,4R,4aS,9S,11S,12S,12aR,12bS)- 12b-(Acetyloxy)-12-(benzoyloxy)- 2a,3,4,4a,9,10,11,12,12a,12b-decahydro4,9,11-trihydroxy-4a,8,13,13-tetramethyl7,11-methano-1Hcyclodeca[3,4]benz[1,2-b]oxete-5,6- dione; 10-Deacetyl-10-oxo-baccatin V | 25MG,50MG | NA | 151636-94-1 | 542.57 | C29H34O10 | 10-Dehydrobaccatin V; | Baccatin III – In house impurity |
PA 02 01570 | 13-Oxo-10-deacetyl Baccatin III | IH | (2aR,4S,4aS,6R,11S,12S,12aR,12bS)- 12b-(Acetyloxy)-12-(benzoyloxy)- 2a,4,4a,10,11,12,12a,12b-octahydro4,6,11-trihydroxy-4a,8,13,13-tetramethyl7,11-methano-1Hcyclodeca[3,4]benz[1,2-b]oxete5,9(3H,6H)-dione; | 25MG,50MG | NA | 92950-42-0 | 542.57 | C29H34O10 | 10-Deacetyl-13-oxobaccatin III; | Baccatin III – In house impurity |
PA 02 01580 | 13-O-(trans-3-Phenyl-glycidyl)-7,10bis[O- (trichloroethoxycarbonyl)]-10-deacetyl Baccatin III | IH | 13-O-(trans-3-Phenyloxirane-2- carboxylate)-7,10-bis[O- (trichloroethoxycarbonyl)]-10-deacetyl Baccatin III | 25MG,50MG | Freezer | NA | 1017.51 | C42H44Cl6O16 | NA | Baccatin III – In house impurity |
PA 02 01590 | 7-{[(2,2,2,-Trichloroethyl)oxy]carbonyl} Baccatin III | IH | Carbonic Acid (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS )-6,12b-Bis(acetyloxy)- 12-(benzoyloxy)- 2a,3,4,4a,5,6,9,10,11,12,12a,12bdodecahydro-9,11-dihydroxy-4a,8,13,13- tetramethyl-5-oxo-7,11-methano-1Hcyclodeca[3,4]benz[1,2-b]oxet-4-yl 2,2,2- trichloroethyl Ester | 25MG,50MG | NA | 103150-33-0 | 762.02 | C34H39Cl3O13 | 7-O-(2,2,2- Trichloroethoxycarbonyl)baccatin III; | Baccatin III – In house impurity |
PA 02 01600 | 7-O-(Trifluoroacetyl) Baccatin III | IH | Baccatin III 7-O-Triflate; Trifluoromethanesulfonic Acid (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS )-6,12b-bis(Acetyloxy)-12-(benzoyloxy)- 2a,3,4,4a,5,6,9,10,11,12,12a,12bdodecahydro-9,11-dihydroxy-4a,8,13,13- tetramethyl-5-oxo-7,11-methano-1Hcyclodeca[3,4]benz[1,2-b]oxet-4-yl Ester | 25MG,50MG | Freezer | 158811-19-9 | 718.69 | C32H37F3O13S | NA | Baccatin III – In house impurity |
PA 02 01610 | 7,10,13-Tri-(O-triethylsilyl) 2-Debenzoyl-2- tigloyl 10-Deacetyl Baccatin III | IH | (2E)-2-Methyl-2-butenoic Acid (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS )- 12b-(acetyloxy)- 2a,3,4,4a,5,6,9,10,11,12,12a,12bdodecahydro-4,6,9-tri-O-triethylsilyl-11- hydroxy-4a,8,13,13-tetramethyl-5-oxo7,11-methano-1Hcyclodeca[3,4]benz[1,2-b]oxet-12-yl Ester | 25MG,50MG | NA | NA | 865.37 | C45H80O10Si3 | NA | Baccatin III – In house impurity |
PA 02 69000 | Bacitracin | IH | N-[[(4R)-2-[(1S,2S)-1-Amino-2- methylbutyl]-4,5-dihydro-4- thiazolyl]carbonyl]-L-leucyl-D-α-glutamylL-isoleucyl-L-lysyl-D-ornithyl-L-isoleucylD-phenylalanyl-L-histidyl-D-α-aspartyl-Lasparagine (10→4)-Lactam | 25MG,50MG | Refrigerator | 1405-87-4 | 1422.69 | C66H103N17O16S | Altracin; Ayfivin; Baciguent; Bacillichin; Bacilliquin; Fortracin; Parentracin; Penitracin; Topitracin; Tropitracin; Zutracin; | Bacitracin – API |
PA 02 69510 | Bacitracin Zinc | IH | Baciferm (8CI); Albac; Bacifarmin; Bacifarmin-zinc; Baciferm PB; Noptracin; ST 56; Zinc-bacitracin; | 25MG,50MG | NA | 1405-89-6 | 1486.06 | C66H101N17O16SZn | NA | Bacitracin – In house impurity |
PA 02 69520 | Bacitracin A | API | NA | 25MG,50MG | NA | NA | 1422.69 | C66H103N17O16S | NA | Bacitracin – In house impurity |
PA 02 69530 | Bacitracin B1 | IH | NA | 25MG,50MG | NA | NA | 1408.66 | C65H101N17O16S | NA | Bacitracin – In house impurity |
PA 02 69540 | Bacitracin B2 | IH | NA | 25MG,50MG | NA | NA | 1408.66 | C65H101N17O16S | NA | Bacitracin – In house impurity |
PA 02 69550 | Bacitracin B3 | IH | NA | 25MG,50MG | NA | NA | 1408.66 | C65H101N17O16S | NA | Bacitracin – In house impurity |
PA 02 70000 | Baclofen | API | β-(Aminomethyl)-4-chlorobenzenepropanoic Acid; β- (Aminomethyl)-p-chlorohydrocinnamic Acid; β-(4-Chlorophenyl)-GABA | 25MG,50MG | Freezer | 1134-47-0 | 213.66 | C10H12ClNO2 | Ba-34647; Baclon; Clofen; Lioresal; | Baclofen – API |
PA 02 70010 | 4-(4-Chlorophenyl)-2-pyrrolidinone | Imp A | 2-Pyrrolidinone, 4-(p-chlorophenyl)- (8CI); (±)-Baclofen Lactam; 4-(4- Chlorophenyl)-2-pyrrolidinone; | 25MG,50MG | NA | 22518-27-0 | 195.65 | C10H10ClNO | (4RS)-4-(4-Chlorophenyl)pyrrolidin2-one; (RS)-4-Amino-3-(4- chlorophenyl)butyric Acid Lactam; 4-(4-Chlorophenyl)-2-pyrrolidone; Baclofen Related Compound A; | Baclofen – Impurity A |
PA 02 70020 | 5-Amino-3-(4-chlorophenyl)-5- oxopentanoic Acid | Imp B | 3-Imidoyl)butanoic Acid; (3RS)-5-Amino3-(4-chlorophenyl)-5-oxopentanoic Acid; | 25MG,50MG | NA | 1141-23-7 | 241.67 | C11H12ClNO3 | NA | Baclofen – Impurity B |
PA 02 70030 | 3-(4-Chlorophenyl)pentanedioic Acid | Imp C | 3-(4-Chlorophenyl)glutaric Acid; β-(pChlorophenyl)glutaric Acid; 3-(pChlorophenyl)glutaric Acid; | 25MG,50MG | Refrigerator | 35271-74-0 | 242.66 | C11H11ClO4 | NA | Baclofen – Impurity C |
PA 02 02000 | Balsalazide | API | 5-[(1E)-2-[4-[[(2- Carboxyethyl)amino]carbonyl]phenyl]diaz enyl]-2-hydroxybenzoic Acid; | 25MG,50MG | Freezer | 80573-04-2 | 357.32 | C17H15N3O6 | (E)-5-[[4-[[(2- Carboxyethyl)amino]carbonyl]phen yl]azo]-2-hydroxybenzoic Acid; Balsalazida; Balsalazido; Balsalazidum; Colazide; | Balsalazide – API |
PA 02 03000 | Balsalazide Disodium Dihydrate | API | 5-[(1E)-[4-[[(2- Carboxyethyl)amino]carbonyl]phenyl]azo ]-2-hydroxybenzoic Acid Disodium Salt Dihydrate; Balsalazide Disodium Hydrate; | 25MG,50MG | NA | 150399-21-6 | 437.31 | C17H17N3Na2O8 | 5-[(1E)-[4-[[(2- Carboxyethyl)amino]carbonyl]phen yl]azo]-2-hydroxyBenzoic acid, -, disodium salt, dihydrate (9CI); Benzoic acid, 5-[[4-[[(2- carboxyethyl)amino]carbonyl]phen yl]azo]-2-hydroxy-, disodium salt, dihydrate, (E)-; | Balsalazide Disodium – API |
PA 02 03510 | (E)-5-[(p-Carboxyphenyl)azo]-2-salicylic Acid Disodium Salt | IH | 2-salicylic Acid Disodium Salt, (E)-5-[(pCarboxyphenyl)azo]-; | 25MG,50MG | NA | NA | 330.2 | C14H8N2Na2O5 | Balsalazide Related Compound A; | Balsalazide – In house impurity |
PA 02 03520 | (E)-5-((m-[(2- Carboxyethyl)carbamoyl]phenyl)azo)-2- salicylic Acid | IH | 2-salicylic Acid, (E)-5-((m-[(2- Carboxyethyl)carbamoyl]phenyl)azo)-; | 25MG,50MG | NA | 1798395-96-6 | 357.32 | C10H12N2O3 | Balsalazide Related Compound B; | Balsalazide – In house impurity |
PA 02 03530 | Balsalazide Aminobenzoyl | IH | 3-(4-Aminobenzoylamino)propionic Acid; 3-[(4-Aminobenzoyl)amino]propanoic Acid; | 25MG,50MG | Refrigerator | *7377-08-4 | 208.21 | C10H12N2O3 | N-(4-Aminobenzoyl)-β-alanine; pAmino-N-benzoyl-β-alanine; N-(4- Aminobenzoyl)-β-alanine; | Balsalazide – In house impurity |
PA 02 03540 | Balsalazide 3-Isomer | IH | 3-[(1E)-2-[4-[[(2- Carboxyethyl)amino]carbonyl]phenyl]diaz enyl]-2-hydroxybenzoic Acid; | 25MG,50MG | Amber Vial, Refrigerator, Under Inert Atmosphere | 1242567-09-4 | 357.32 | C17H15N3O6 | (E)-3-[4-(2- Carboxyethylcarbamoyl)phenylazo] salicylic Acid; Balsalazide USP Impurity 2; | Balsalazide – In house impurity |
PA 02 03550 | Balsalazide Isopropyl Ester | IH | 5-[(1E)-2-[4-[[(1-methylethoxy-3- oxopropyl)amino]carbonyl]phenyl]diazen yl]-2-hydroxybenzoic Acid; | 25MG,50MG | Amber Vial, Freezer | 1346606-13-0 | 399.4 | C20H21N3O6 | (E)-2-Hydroxy-5-[[4-[[(3- isopropoxy-3- oxopropyl)amino]carbonyl]phenyl]a zo]benzoic Acid; Balsalazide USP Impurity 5; | Balsalazide – In house impurity |
PA 02 03560 | 2-O-[4-[[(2- carboxyethyl)amino]carbonyl]phenyl] Balsalazide | IH | 5-[(1E)-2-[4-[[(2- carboxyethyl)amino]carbonyl]phenyl]diaz enyl]-2-[[(2- carboxyethyl)amino]carbonyl]phenoxy]be nzoic Acid; | 25MG,50MG | Amber Vial, Refrigerator, Under Inert Atmosphere | 1346606-62-9 | 548.5 | C27H24N4O9 | (E)-2-[4-(2- Carboxyethylcarbamoyl)phenoxy]- 5-[[4-(2- carboxyethylcarbamoyl)]phenylazo ]benzoic Acid; Balsalazide USP Impurity 4; | Balsalazide – In house impurity |
PA 02 03570 | 2’-[(1E)-2-[4-[[(2- carboxyethyl)amino]carbonyl]phenyl]diaze nyl] Balsalazide | IH | 5-[(1E)-2-[2-[(1E)-2-[4-[[(2- carboxyethyl)amino]carbonyl]phenyl]diaz enyl]-4-[[(2- carboxyethyl)amino]carbonyl]phenyl]diaz enyl]-2-hydroxybenzoic Acid; | 25MG,50MG | Amber Vial, Refrigerator, Under Inert Atmosphere | 1346606-53-8 | 576.51 | C27H24N6O9 | (E,E)-5-[[2-[4-(2- Carboxyethylcarbamoyl)phenylazo]- 4-(2- carboxyethylcarbamoyl)]phenylazo ]salicylic Acid; Balsalazide USP Impurity 3; | Balsalazide – In house impurity |
PA 02 03580 | 3-[(1E)-2-[4-[[(2- carboxyethyl)amino]carbonyl]phenyl]diaze nyl] Balsalazide | IH | 3,5-Bis[(1E)-2-[4-[[(2- carboxyethyl)amino]carbonyl]phenyl]diaz enyl]-2-hydroxybenzoic Acid; | 25MG,50MG | NA | 1242567-11-8 | 578.51 | C27H24N6O9 | (E,E)-3,5-Di-[4-(2- Carboxyethylcarbamoyl)phenylazo] ]salicylic Acid; Balsalazide USP Impurity 1; | Balsalazide – In house impurity |
PA 02 87000 | Bambuterol Hydrochloride | API | 5-[(1RS)-2-[(1,1- Dimethylethyl)amino]-1- hydroxyethyl]-1,3-phenylene bis(dimethylcarbamate) Hydrochloride; N,NDimethylcarbamic Acid 3- [[(Dimethylamino)carbonyl]oxy]- 5 | 25MG,50MG | Freezer | 81732-46-9 | 403.9 | C18H30ClN3O5 | Dimethylcarbamic Acid 5-[2- [(1,1-Dimethylethyl)amino]-1- hydroxyethyl]-1,3-phenylene Ester Monohydrochloride; Bambec; 5-(2-(tertButylamino)-1-hydroxyethyl) | Bambuterol Hydrochloride – API |
PA 02 87050 | 5-Acetyl-1,3-phenylene bis(dimethylcarbamate) | Imp E | N,N-Dimethylcarbamic Acid C,C’- (5-Acetyl-1,3-phenylene) Ester; 5- Des[2-(tert-butylamino)] 5-Acetyl Bambuterol; | 25MG,50MG | NA | 81732-48-1 | 294.3 | C14H18N2O5 | Dimethylcarbamic Acid 5- Acetyl-1,3-phenylene Ester; 5-Acetyl-1,5-phenylene Bis(dimethylcarbamate); | Bambuterol Hydrochloride – Impurity G |
PA 02 93000 | Bamifylline Hydrochloride | API | 8-Benzyl-7-(2-(ethyl(2- hydroxyethyl)amino)ethyl)-1,3- dimethyl-1H-purine-2,6(3H,7H)- dione Hydrochloride; | 25MG,50MG | NA | 20684-06-4 | 421.92 | C20H28ClN5O3 | 8′-Benzyl-7-(2-(ethyl(2- hydroxyethyl)amino)ethyl)th eophylline Hydrochloride; | Bamifylline Hydrochloride – API |
PA 02 04000 | BAPTA | API | 1,2-Bis(2-aminophenoxy)ethaneN,N,N’,N’-tetraacetic Acid; N,N’-[1,2- Ethanediylbis(oxy-2,1-phenylene)]bis[N- (carboxymethyl)glycine; BAPTA; | 25MG,50MG | Freezer | 85233-19-8 | 476.43 | C22H24N2O10 | NA | BAPTA – API |
PA 02 04510 | BAPTA-tetracesium Salt | IH | N,N’-[1,2-Ethanediylbis(oxy-2,1- phenylene)]bis[N-(carboxymethyl)glycine Tetracesium Salt; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 480436-84-8 | 1004.2 | C22H20Cs4N2O10 | NA | BAPTA – In house impurity |
PA 02 04520 | BAPTA-AM | IH | N,N’-[1,2-Ethanediylbis(oxy-2,1- phenylene)]bis[N-[2-[(acetyloxy)methoxy]- 2-oxoethyl]glycine 1,1′- Bis[(acetyloxy)methyl] Ester; BAPTAAM; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 126150-97-8 | 764.68 | C34H40N2O18 | 1,2-Bis(2-aminophenoxy)ethaneN,N,N’,N’-tetraacetic Acid Tetraacetoxymethyl Ester; | BAPTA – In house impurity |
PA 02 04530 | BAPTA-APM | IH | N-[4-(3-Aminopropyl)-2-[2-[2- [bis(carboxymethyl)amino]-5- methylphenoxy]ethoxy]phenyl]-N- (carboxymethyl)glycine Tetrapotassium Salt; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 352000-08-9 | 699.92 | C26H29K4N3O10 | BAPTA-APM; 5-(3-Aminopropyl)- 5′-methyl-bis-(2- aminophenoxymethyleneN,N,N’,N’-tetraacetate Tetrapotassium Salt; | BAPTA – In house impurity |
PA 02 04540 | BAPTA-tetramethyl Ester | IH | N,N’-[1,2-Ethanediylbis(oxy-2,1- phenylene)]bis[N-(2-methoxy-2- oxoethyl)glycine 1,1′-Dimethyl Ester; | 25MG,50MG | Freezer | 125367-34-2 | 532.54 | C26H32N2O10 | Tetramethyl 1,2-Bis-(2- aminophenoxy)ethane- N,N,N’,N’- tetraacetate; Tetramethyl 2,2′,2”,2”’-(((Ethane-1,2- diylbis(oxy))bis(2,1- phenylene))bis(azanetriyl))tetraace tate; | BAPTA – In house impurity |
PA 02 04550 | 5,5’-Dinitro-BAPTA-tetramethyl Ester | IH | N,N’-[1,2-Ethanediylbis[oxy(4-nitro-2,1- phenylene)]]bis[N-(2-methoxy-2- oxoethyl)glycine Dimethyl Ester; | 25MG,50MG | NA | 125367-35-3 | 622.53 | C26H30N4O14 | NA | Bazedoxifene Acetate – API |
PA 02 85000 | Bazedoxifene Acetate | API | 1-[[4-[2-(Hexahydro-1H-azepin-1- yl)ethoxy]phenyl]methyl]-2-(4- hydroxyphenyl)-3-methyl-1H-indol-5-ol Acetate; | 25MG,50MG | Refrigerator | 198481-33-3 | 530.65 | C32H38N2O5 | 1-[4-(2-Azepan-1-yl-ethoxy)benzyl]- 2-(4-hydroxyphenyl)-3-methyl-1Hindol-5-ol Acetate; TSE 424; Viviant; WAY-TES 424; | Bazedoxifene Acetate – In house impurity |
PA 02 85510 | Bazedoxifene 5-O-Benzyl Impurity | IH | 5-O-Benzylbazedoxifene; 4-[1-[[4-[2- (Hexahydro-1H-azepin-1- yl)ethoxy]phenyl]methyl]-3-methyl-5- (phenylmethoxy)-1H-indol-2-yl]phenol; Bazedoxifene Impurity 4; | 25MG,50MG | NA | 328933-58-0 | 560.73 | C37H40N2O3 | 4-(1-(4-(2-(Azepan-1- yl)ethoxy)benzyl)-5-(benzyloxy)-3- methyl-1H-indol-2-yl)phenol; | Bazedoxifene Acetate – In house impurity |
PA 02 85520 | Des(1-azepanyl)ethyl Bazedoxifene | IH | Bazedoxifene Triol Impurity; 2-(4- Hydroxyphenyl)-1-[(4- hydroxyphenyl)methyl]-3-methyl-1H-Indol5-ol; | 25MG,50MG | Refrigerator | 104599-10-2 | 345.39 | C22H19NO3 | 1-(4-Hydroxybenzyl)-2-(4- hydroxyphenyl)-3-methyl-1H-indol5-ol; Bazedoxifene Impurity 3; | Bazedoxifene Acetate – In house impurity |
PA 02 85530 | N-(2-Acetyl-4-hydroxyphenyl)-N-(4-(2- (azepan-1-yl)ethoxy)benzyl)-4- hydroxybenzamide | IH | Bazedoxifene Impurity 5; | 25MG,50MG | NA | NA | 502.6 | C30H34N2O5 | NA | Bazedoxifene Acetate – In house impurity |
PA 02 85540 | Bazedoxifene N-Oxide | IH | 1-[[4-[2-(Hexahydro-1-oxido-1H-azepin-1- yl)ethoxy]phenyl]methyl]-2-(4- hydroxyphenyl)-3-methyl-1H-indol-5-ol; 1- (2-(4-((5-Hydroxy-2-(4-hydroxyphenyl)-3- methyl-1H-indol-1- yl)methyl)phenoxy)ethyl)azepane 1- oxide; | 25MG,50MG | Amber Vial, Refrigerator, Under inert atmosphere | 1174289-22-5 | 486.6 | C30H34N2O4 | NA | Bazedoxifene Acetate – In house impurity |
PA 02 05000 | Beclomethasone Dipropionate | API | Beclometasone Dipropionate; 9α-Chloro16β-methylprednisolone 17,21- dipropionate; Aerobec; Aldecin; | 25MG,50MG | Freezer | *5534-09-8 | 521.04 | C28H37ClO7 | Beclotide; Clenil A; Entyderma; QVAR; Sanasthmax; Viarox; Ventolair; | Beclomethasone Dipropionate – API |
PA 02 05010 | Beclomethasone 21-Propionate | Imp A | (11β,16β)-9-Chloro-11,17-dihydroxy-16- methyl-21-(1-oxopropoxy)-pregna-1,4- diene-3,20-dione; Beclomethasone 21- Monopropionate; | 25MG,50MG | Freezer | 69224-79-9 | 464.98 | C25H33ClO6 | 9-Chloro-11β,17-dihydroxy-16βmethyl-3,20-dioxopregna-1,4-dien21-yl Propanoate; | Beclomethasone Dipropionate – Impurity A |
PA 02 05020 | Beclomethasone 21-Acetate 17- Propionate | Imp B | (11β,16β)-21-(acetyloxy)-9-chloro-11- hydroxy-16-methyl-17-(1- oxopropoxy)pregna-1,4-diene-3,20- dione; 9-Chloro-11β,17,21-trihydroxy16β-methylpregna-1,4-diene-3,20-dione 21-Acetate 17-Propionate; | 25MG,50MG | NA | *5534-08-7 | 507.02 | C27H35ClO7 | 21-(acetyloxy)-9-chloro-11βhydroxy-16β-methyl-3,20- dioxopregna-1,4-dien-17-yl Propanoate | Beclomethasone Dipropionate – Impurity B |
PA 02 05030 | Beclomethasone 21-Butyrate 17- Propionate | Imp C | (11β,16β)-9-Chloro-11-hydroxy-16- methyl-21-(1-oxobutoxyloxy)-17-(1- oxopropoxy)pregna-1,4-diene-3,20- dione; 9-Chloro-11β,17,21-trihydroxy16β-methylpregna-1,4-diene-3,20-dione 21-Butyrate 17-Propionate; | 25MG,50MG | NA | NA | 535.07 | C29H39ClO7 | 9-Chloro-11β-hydroxy-16β-methyl3,20-dioxo-17-(propanoyloxy)- pregna-1,4-dien-21-yl Butanoate | Beclomethasone Dipropionate – Impurity C |
PA 02 05040 | 9-Deschloro-9-bromo Beclomethasone Dipropionate | Imp D | (11β,16β)-9-Bromo-11-hydroxy-16- methyl-17,21-bis(1-oxopropoxy)pregna1,4-diene-3,20-dione; 9-Bromo-11βhydroxy-16β-methyl-3,20-dioxopregna1,4-diene-17,21-diyl Dipropanoate; | 25MG,50MG | Freezer | 52092-14-5 | 565.49 | C28H37BrO7 | NA | Beclomethasone Dipropionate – Impurity D |
PA 02 05060 | 6α-Bromo Beclomethasone Dipropionate | Imp F | (6α,11β,16β)-6-Bromo-9-chloro-11- hydroxy-16-methyl-17,21-bis(1- oxopropoxy)pregna-1,4-diene-3,20- dione; 6α-Bromo-9-chloro-11β-hydroxy16β-methyl-3,20-dioxopregna-1,4-diene17,21-diyl Dipropanoate; | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 887130-69-0 | 599.94 | C28H36BrClO7 | NA | Beclomethasone Dipropionate – Impurity F |
PA 02 05120 | 1,2-Dihydro Beclomethasone Dipropionate | Imp L | (11β,16β)-9-chloro-11-hydroxy-16- methyl-17,21-bis(1-oxopropoxy)pregn-4- ene-3,20-dione; 1,2- Dihydrobeclometasone Dipropopionate; 9-chloro-11β-hydroxy-16β-methyl-3,20- dioxopregn-4-ene-17,21-diyl Dipropanoate; | 25MG,50MG | NA | 114371-33-4 | 523.06 | C28H39ClO7 | NA | Beclomethasone Dipropionate – Impurity L |
PA 02 05130 | Δ6-1,2-Dihydro Beclomethasone Dipropionate | Imp M | (11β,16β)-9-chloro-11-hydroxy-16- methyl-17,21-bis(1-oxopropoxy)pregna4,6-diene-3,20-dione; 1,2-Dihydro-6,7- dehydrobeclometasone Dipropopionate; | 25MG,50MG | NA | NA | 521.04 | C28H37ClO7 | 9-chloro-11β-hydroxy-16β-methyl3,20-dioxopregna-4,6-diene-17,21- diyl Dipropanoate; | Beclomethasone Dipropionate – Impurity M |
PA 02 05140 | 2-Bromo Beclomethasone Dipropionate | Imp N | (11β,16β)-2-Bromo-9-chloro-11-hydroxy16-methyl-17,21-bis(1- oxopropoxy)pregna-1,4-diene-3,20- dione; | 25MG,50MG | NA | 1204582-47-7 | 599.94 | C28H36BrClO7 | 2-bromo-9-chloro-11β-hydroxy16β-methyl-3,20-dioxopregna-1,4- diene-17,21-diyl Dipropanoate; | Beclomethasone Dipropionate – Impurity N |
PA 02 05510 | Beclomethasone-∆17,20 21-Aldehyde | IH | (11β,16β,17Z)-9-Chloro-11,20-dihydroxy16-methyl-3-oxo-pregna-1,4,17(20)-trien21-al; | 25MG,50MG | Freezer, Under Inert Atmosphere | 1174035-77-8 | 390.9 | C22H27ClO4 | NA | Beclomethasone Dipropionate – In house impurity |
PA 02 05520 | 21-(1-Ethoxyethyl) Beclomethasone 9,11-Epoxide | IH | 21-(1-Ethoxyethyl) Beclomethasone 9,11-Epoxide; | 25MG,50MG | NA | NA | 444.56 | C26H36O6 | NA | Beclomethasone Dipropionate – In house impurity |
PA 02 05530 | 21-(1-Ethoxyethyl) Beclomethasone | IH | 21-(1-Ethoxyethyl) Beclomethasone | 25MG,50MG | NA | NA | 481.02 | C26H37ClO6 | NA | Beclomethasone Dipropionate – In house impurity |
PA 02 05540 | Beclomethasone 11,21-Ditrifluoroacetate | IH | 9α-Chloro-16β-methylprednisolone 11,21-Ditrifluoroacetate; | 25MG,50MG | NA | NA | 600.93 | C26H27ClF6O7 | 9α-Chloro-11β,17α,21-trihydroxy16β-methylpregna-1,4-diene-3,20- dione -11,21-ditrifluoroacetate; | Beclomethasone Dipropionate – In house impurity |
PA 02 05550 | Beclomethasone 17-Propionate | IH | (11β,16β)-9-Chloro-11,21-dihydroxy-16- methyl-17-(1-oxopropoxy)-pregna-1,4- diene-3,20-dione; Beclomethasone 17- Monopropionate; | 25MG,50MG | Freezer | 5534-18-9 | 464.98 | C25H33ClO6 | NA | Beclomethasone Dipropionate – In house impurity |
PA 02 05560 | 21-Dehydro Beclomethasone | IH | (11β,16β)-9-Chloro-11,17- dihydroxy-16-methyl-3,20- dioxopregna-1,4-dien-21-al; | 25MG,50MG | NA | NA | 406.9 | C22H27ClO5 | NA | Beclomethasone Dipropionate – In house impurity |
PA 02 05570 | 21-Dehydro Beclomethasone 17- Propionate | IH | (11β,16β)-9-Chloro-11-hydroxy16-methyl-17-(1-oxopropoxy)- 3,20-dioxopregna-1,4-dien-21-al; | 25MG,50MG | NA | NA | 462.96 | C25H31ClO6 | NA | Beclomethasone Dipropionate – In house impurity |
PA 02 98000 | Befiradol | API | 1-(3-Chloro-4-fluorobenzoyl)-4- fluoro-N-[(5-methyl-2- pyridinyl)methyl]-4- piperidinemethanamine; | 25MG,50MG | NA | 208110-64-9 | 393.86 | C20H22ClF2N3O | (3-Chloro-4-fluorophenyl)(4- fluoro-4-((((5-methylpyridin-2- yl)methyl)amino)methyl)pipe ridin-1-yl)methanone; | Befiradol – API |
PA 02 06000 | Benazepril Hydrochloride | API | (3S)-3-[[(1S)-1-(Ethoxycarbonyl)-3- phenylpropyl]amino]-2,3,4,5-tetrahydro-2- oxo-1H-1-benzazepine-1-acetic Acid Hydrochloride; Lotensin; | 25MG,50MG | Freezer | 86541-74-4 | 460.95 | C24H29ClN2O5 | NA | Benazepril Hydrochloride – API |
PA 02 06510 | Benazeprilat | IH | (3S)-3-[[(1S)-1-Carboxy-3- phenylpropyl]amino]-2,3,4,5-tetrahydro-2- oxo-1H-1-benzazepine-1-acetic Acid; | 25MG,50MG | Freezer, Under Inert Atmosphere | 86541-78-8 | 396.44 | C22H24N2O5 | Benazepril Related Compound C; | Benazepril – In house impurity |
PA 02 06520 | Benazeprilat Benzyl Ester Analogue Trifluoroacetic Acid Salt | IH | (3S)-2,3,4,5-Tetrahydro-2-oxo-3-[[3- phenyl-1S-[1- (phenylmethoxy)carbonyl]propyl]amino]- 1H-1-benzazepine-1-acetic Acid Trifluoroacetic Acid Salt; | 25MG,50MG | NA | 1356578-34-1 | 600.58 | C31H31F3N2O7 | NA | Benazepril – In house impurity |
PA 02 06530 | 1’-epi-Benazeprilat Benzyl Ester Analogue, Trifluoroacetic Acid Salt | IH | (3S)-2,3,4,5-Tetrahydro-2-oxo-3-[[3- phenyl-1R-[1- (phenylmethoxy)carbonyl]propyl]amino]- 1H-1-benzazepine-1-acetic Acid Trifluoroacetic Acid Salt; | 25MG,50MG | NA | 1356930-99-8 | 600.58 | C31H31F3N2O7 | NA | Benazepril – In house impurity |
PA 02 06540 | Benazeprilat Acyl-β-D-glucuronide | IH | Glucuronide, benazeprilat Acyl-β-D-; | 25MG,50MG | Hygroscopic, Store under Inert atmosphere Freezer | NA | 572.56 | C28H32N2O11 | NA | Benazepril – In house impurity |
PA 02 06550 | 1’-epi-Benazeprilat Acyl-β-D-glucuronide | IH | 1’-epi-Benazeprilat Acyl-β-D-glucuronide; | 25MG,50MG | NA | 1240792-52-2 | 572.56 | C28H32N2O11 | NA | Benazepril – In house impurity |
PA 02 06560 | Benazeprilat Acyl-β-D-glucuronide Dibenzyl Ester | IH | Benazeprilat Acyl-β-D-glucuronide Dibenzyl Ester; | 25MG,50MG | NA | NA | 752.81 | C42H44N2O11 | NA | Benazepril – In house impurity |
PA 02 06570 | 1’-epi-Benazeprilat Acyl-β-D-glucuronide Dibenzyl Ester | IH | 1’-epi-Benazeprilat Acyl-β-D-glucuronide Dibenzyl Ester; | 25MG,50MG | NA | NA | 752.81 | C42H44N2O11 | NA | Benazepril – In house impurity |
PA 02 06580 | Benazeprilat Benzyl Ester (Glycine)tertbutyl Ester | IH | (3S)-2,3,4,5-Tetrahydro-2-oxo-3-[[(1S)-3- phenyl-1- [(phenylmethoxy)carbonyl]propyl]amino]- 1H-1-benzazepine-1-acetic Acid 1,1- Dimethylethyl Ester; | 25MG,50MG | NA | 1356838-13-5 | 542.67 | C33H38N2O5 | NA | Benazepril – In house impurity |
PA 02 06590 | 1’-epi-Benazeprilat Benzyl Ester (Glycine)tert-butyl Ester | IH | (3S)-2,3,4,5-Tetrahydro-2-oxo-3-[[(1R)-3- phenyl-1- [(phenylmethoxy)carbonyl]propyl]amino]- 1H-1-benzazepine-1-acetic Acid 1,1- Dimethylethyl Ester; | 25MG,50MG | NA | 1356011-61-4 | 542.67 | C33H38N2O5 | NA | Benazepril – In house impurity |
PA 02 06600 | Benazeprilat Ethyl Ester Hydrochloride | IH | (3S)-3-[[(1S)-1-Carboxy-3- phenylpropyl]amino]-2,3,4,5-tetrahydro-2- oxo-1H-1-benzazepine-1-acetic Acid Ethyl Ester Hydrochloride; | 25MG,50MG | Freezer | NA | 460.95 | C24H29ClN2O5 | NA | Benazepril – In house impurity |
PA 02 68000 | Bendamustine | API | 5-[Bis(2-chloroethyl)-amino]-1- methyl-1H-benzimidazole-2- butanoic Acid; | 25MG,50MG | NA | 16506-27-7 | 358.26 | C16H21Cl2N3O2 | 4-(5-(Bis(2- chloroethyl)amino)-1-methyl1H-benzo[d]imidazol-2- yl)butanoic Acid; | Bendamustine – API |
PA 02 07000 | Bendamustine Hydrochloride | API | 5-[Bis(2-chloroethyl)-amino]-1-methyl-1Hbenzimidazole-2-butanoic Acid Hydrochloride; Cytostasan; Ribomustin; Treanda; | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 3543-75-7 | 394.72 | C16H22Cl3N3O2 | NA | Bendamustine Hydrochloride – API |
PA 02 07510 | Bendamustine Methyl Ester | IH | 5-[Bis(2-chloroethyl)amino]-1-methyl-1Hbenzimidazole-2-butanoic Acid Methyl Ester; | 25MG,50MG | NA | 109882-25-9 | 372.29 | C17H23Cl2N3O2 | NA | Bendamustine Hydrochloride – In house impurity |
PA 02 07520 | Bendamustine Ethyl Ester | IH | 4-[5-[Bis(2-chloroethyl)amino]-1- methylbenzimidazol-2-yl]butanoic Acid Ethyl Ester | 25MG,50MG | NA | 87475-54-5 | 386.32 | C18H25Cl2N3O2 | Ethyl 4-(5-(Bis(2- chloroethyl)amino)-1-methyl-1Hbenzo[d]imidazol-2-yl)butanoate; | Bendamustine Hydrochloride – In house impurity |
PA 02 07530 | Bendamustine Isopropyl Ester | IH | 5-[Bis(2-chloroethyl)-amino]-1-methyl-1Hbenzimidazole-2-butanoic Acid Isopropyl Ester; Isopropyl 4-(5-[Bis(2- chloroethyl)amino]-1-methyl-1Hbenzimidazol-2-yl)butanoate; | 25MG,50MG | NA | 1313020-25-5 | 400.34 | C19H27Cl2N3O2 | 4-[5-[Bis(2-chloroethyl)amino]-1- methylbenzimidazol-2-yl]butanoic Acid Isopropyl Ester; | Bendamustine Hydrochloride – In house impurity |
PA 02 07540 | Dihydroxy Bendamustine | IH | 5-[Bis(2-hydroxyethyl)amino]-1-methyl1H-benzimidazole-2-butanoic Acid | 25MG,50MG | NA | 109882-30-6 | 321.37 | C16H23N3O4 | NA | Bendamustine Hydrochloride – In house impurity |
PA 02 07550 | Deschloroethyl Bendamustine Hydrochloride | IH | 5-[(2-Chloroethyl)amino]-1-methyl-1Hbenzimidazole-2-butanoic Acid; 4-[5-(2- Chloroethylamino)-1-methylbenzimidazol2-yl]butanoic Acid; | 25MG,50MG | NA | NA | 332.23 | C14H19Cl2N3O2 | NA | Bendamustine Hydrochloride – In house impurity |
PA 02 07560 | Bendamustine Dideschloroethyl Acid | IH | 4-(5-Amino-1-methyl-1Hbenzo[d]imidazol-2-yl)butanoic Acid; Dideschloroethyl Bendamustine; | 25MG,50MG | NA | NA | 233.27 | C12H15N3O2 | NA | Bendamustine Hydrochloride – In house impurity |
PA 02 07570 | Bendamustine Dideschloroethyl Ethyl Ester | IH | 1-Methyl-5-amino-1H-benzimidazole-2- butanoic Acid Ethyl Ester; 5-Amino-1- methyl-2-benzimidazolebutyric Acid Ethyl Ester; | 25MG,50MG | NA | 3543-73-5 | 261.32 | C14H19N3O2 | 4-(5-Amino-1-methyl-1Hbenzo[d]imidazol-2-yl)butanoic acid ethyl ester; | Bendamustine Hydrochloride – In house impurity |
PA 02 07580 | Bendamustine Nitro Ethyl Ester | IH | 1-Methyl-5-nitro-2-benzimidazolebutyric Acid Ethyl Ester; Bendamustine Nitro Ethyl Ester; | 25MG,50MG | NA | 3543-72-4 | 291.3 | C14H17N3O2 | 1-Methyl-5-nitro-1H-benzimidazole2-butanoic Acid Ethyl Ester; | Bendamustine Hydrochloride – In house impurity |
PA 02 07590 | Hydroxy Bendamustine | IH | 5-[(2-Chloroethyl)(2- hydroxyethyl)amino]-1-methyl-1Hbenzimidazole-2-butanoic Acid; | 25MG,50MG | NA | 109882-27-1 | 339.82 | C16H22ClN3O3 | 4-(5-((2-Chloroethyl)(2- hydroxyethyl)amino)-1- methyl-1H-benzo[d]imidazol2-yl)butanoic Acid; | Bendamustine Hydrochloride – In house impurity |
PA 02 07600 | 5-[(2-Chloroethyl)(2-hydroxyethyl)amino]-1- methyl-1H-benzimidazole-2-butanoic Acid 1-Methylethyl Ester | IH | 4-(5-((2-Chloroethyl)(2- hydroxyethyl)amino)-1-methyl-1Hbenzoimidazol-2-yl)butyric Acid Isopropyl Ester; | 25MG,50MG | NA | 1797008-41-3 | 381.9 | C19H28ClN3O3 | Isopropyl 4-(5-((2-Chloroethyl)(2- hydroxyethyl)amino)-1-methyl-1Hbenzo[d]imidazol-2-yl)butanoate; | Bendamustine Hydrochloride – In house impurity |
PA 02 07610 | 4-(6-(2-Chloroethyl)-3-methyl3,6,7,8- tetrahydroimidazo[4’,5’:5,6]benzo[ 1,2-b][1,4]thiazin-2-yl)butanoic Acid | IH | 6-(2-Chloroethyl)-3,6,7,8- tetrahydro-3-methyl-Imidazo[4,5- h][1,4]benzothiazine-2-butanoic Acid; 4-(7,8-Dihydro-6-(2- Chloroethylamino)-3-methyl-1,4- thiazino[3,2- | 25MG,50MG | NA | 191939-34-1 | 353.87 | C16H20ClN3O2S | NA | Bendamustine Hydrochloride – In house impurity |
PA 02 07620 | Isopropyl 4-(1-Methyl-5-nitro-1Hbenzo[d]imidazol-2-yl)Butanoate | IH | (1-Methyl-5-nitro-1H-benzo[d] imidazol-2-yl)butanoate, isopropyl 4-; | 25MG,50MG | NA | 1374784-01-6 | 305.33 | C15H19N3O4 | NA | Bendamustine Hydrochloride – In house impurity |
PA 02 95000 | Benidipine Hydrochloride | API | rac Benidipine Hydrochloride; (4R)-rel-1,4-Dihydro-2,6-dimethyl4-(3-nitrophenyl)-3,5- pyridinedicarboxylic Acid 3- Methyl 5-[-1-(Phenylmethyl)-3- piperidinyl] Ester Hydrochloride; (+/-)-Benidipine Hydrochloride; | 25MG,50MG | Freezer | 91599-74-5 | 542.02 | C28H32ClN3O6 | NA | Benidipine Hydrochloride – API |
PA 02 08000 | Benperidol | API | 1-[1-[4-(4-Fluorophenyl)-4-oxobutyl]-4- piperidinyl]-1,3-dihydro-2H-benzimidazol2-one; 1-[1-[3-(p-Fluorobenzoyl)propyl]-4- piperidyl]-2-benzimidazolinone; 1-(1-(4- (4-Fluorophenyl)-4-oxobutyl)piperidin-4- yl)-1H-benzo[d]imidazol-2(3H)-one; | 25MG,50MG | NA | 2062-84-2 | 381.44 | C22H24FN3O2 | 1-(1-[4-(p-Fluorophenyl)-4- oxobutyl]piperidin-4-yl)-2- benzimidazolinone, 1-[1-[3-(pFluorobenzoyl)propyl]-4-piperidyl]- 2-benzimidazolinone, Anquil, Benperidol, Benzoperidol, Benzperidol, CB 8089, Frenactil, Frenactyl, Glianimon, McN-JR | Benperidol – API |
PA 02 08010 | 4-(2-Keto-1-benzimidazolinyl)piperidine | Imp A | 1,3-Dihydro-1-(4-piperidinyl)-2Hbenzimidazol-2-one; R 30507; 1-(Piperin4-yl)-1,3-dihdro-2H-benzimidazol-2-one; 1-(4-Piperidyl)-2-benzimidazolinone; 1,3- Dihydro-1-(4-piperidinyl)benzimidazol-2- one; | 25MG,50MG | NA | 20662-53-7 | 217.27 | C12H15N3O | 1-(4-Piperidinyl)-1,3-dihydro-2Hbenzimidazol-2-one; 4-(2-Oxo-1,3- dihydro- benzimidazol-1- yl)piperidine; 4-(2-Oxo-1- benzimidazolinyl)piperidine; 4-(2- Oxo-1-benzimidazoly)piperidine; 4- (2-Oxo-1- | Benperidol – Impurity A |
PA 02 08510 | 4-Chloro-4′-fluorobutyrophenone | IH | 4-Chloro-1-(4-fluorophenyl)-1-butanone; 4-chloro-4’-fluorobutyrophenone; 1- Chloro-4-(4-fluorophenyl)-4-oxobutane; 3- (4-Fluorobenzoyl)propyl Chloride; | 25MG,50MG | Refrigerator | 3874-54-2 | 200.64 | C10H10ClFO | 3-(4-Fluorophenylcarbonyl)-1- chloropropane; 3-Chloropropyl 4- Fluorophenyl Ketone; 4-(4- Fluorophenyl)-4-oxobutyl Chloride; 4-(p-Fluorophenyl)-4-oxobutyl Chloride; NSC 87082; | Benperidol – In house impurity |
PA 02 94000 | Benserazide Hydrochloride | API | 2-Amino-3-hydroxy-N’-[(2,3,4- trihydroxyphenyl)methyl]propane hydrazide Hydrochloride; (2RS)-2- Amino-3-hydroxy-2′-(2,3,4- trihydroxybenzyl)propanohydrazid e Hydrochloride; | 25MG,50MG | Freezer | 14919-77-8 | 293.7 | C10H16ClN3O5 | DL-Serine N2-(2,3,4- trihydroxybenzyl)hydrazide Hydrochloride; N-(DL-Seryl)- N’-(2,3,4- trihydroxybenzyl)hydrazine Hydrochloride; DL-Serine 2 | Benserazide Hydrochloride – API |
PA 02 09000 | Benzalkonium Chloride | API | Alkyldimethylbenzylammonium Chloride; Arquad CB 30; BTC; BTC 2565; BTC 471; Benzalkon A; Benzalkonium chloride; Biowash; Cedium; Culversan LC 80; Dimanin A; Erional EL; Genamin KDS; Kemamine BAC; Konrapo; Leda benzalkonium chloride; Magna M 407; | 25MG,50MG | NA | 8001-54-5 | 283.88 | C9H13NRCl | Major C 100; Mefarol; Morpan BC 50; Mycosan; Mycosan S; Neo germ-i-tol; Niccanon 50; Nikaekstra M; Osvan; P 3-Triquart AP; Parvosol II RTU; Phagomucor; Preventol R 80; Quaternium 1; Quatramine 50; Rhodaquat RP 50; Rhodaquat RP 80; Rodalon; Romergal CB; Smeik; Suma Bac | Benzalkonium Chloride – API |
PA 02 09010 | Benzyl Alcohol | Imp A | α-Toluenol; (Hydroxymethyl)benzene; Benzenecarbinol; Benzylic Alcohol; | 25MG,50MG | Room Temp | 100-51-6 | 108.14 | C7H8O | NSC 8044; Phenylcarbinol; Phenylmethanol; Phenylmethyl Alcohol; Sunmorl BK 20; TB 13G; α-Hydroxytoluene; | Benzalkonium Chloride – Impurity A |
PA 02 09020 | Benzaldehyde | Imp B | Artificial Almond Oil; Benzaldehyde FFC; Benzenecarbonal; Benzenecarboxaldehyde; | 25MG,50MG | Refrigerator, under inert atmosphere | 100-52-7 | 106.12 | C7H6O | Benzoic Acid Aldehyde; Benzoic Aldehyde; NSC 7917; Phenylformaldehyde; | Benzalkonium Chloride – Impurity B |
PA 02 10000 | Benzamidenafil | API | rac Xanthoanthrafil; N-[(3,4- Dimethoxyphenyl)methyl]-2-[(2-hydroxy1-methylethyl)amino]-5-nitro-benzamide; | 25MG,50MG | Refrigerator | 1020251-53-9 | 389.4 | C19H23N3O6 | Xanthoanthrafil; | Benzamidenafil – API |
PA 02 10510 | N-[(3,4-Dimethoxyphenyl)methyl]-2-[[(1R)- 2-hydroxy-1-methylethyl]amino]-5-nitrobenzamide | IH | (R)-Xanthoanthrafil; FR 226807; | 25MG,50MG | Refrigerator | 247568-68-9 | 389.4 | C19H23N3O6 | NA | Benzamidenafil – In house impurity |
PA 02 10520 | N-[(3,4-Dimethoxyphenyl)methyl]-2-[[(1S)- 2-hydroxy-1-methylethyl]amino]-5-nitrobenzamide | IH | (S)-Xanthoanthrafil; | 25MG,50MG | NA | 247567-47-1 | 389.4 | C19H23N3O6 | NA | Benzamidenafil – In house impurity |
PA 02 11000 | Benzbromarone | API | (3,5-Dibromo-4-hydroxyphenyl)(2-ethyl-3- benzofuranyl)methanone; 3,5-Dibromo-4- hydroxyphenyl 2-ethyl-3-benzofuranyl Ketone; | 25MG,50MG | Refrigerator | 3562-84-3 | 424.08 | C17H12Br2O3 | 2-Ethyl-3-(3,5-dibromo-4- hydroxybenzoyl)benzofuran; Azubromaron; Benzbromaron; Besuric; Desuric; L 2214; L 2214- Labaz; MJ 10061; Max-Uric; Minuric; NSC 85433; Narcaricin; Normurat; Uricovac; Urinorm; | Benzbromarone – API |
PA 02 12000 | Benzenesulfonic Acid | API | Benzene sulphonic Acid; Benzenesulphonic Acid; Phenylsulfonic Acid; Phenylsuphonic Acid; | 25MG,50MG | NA | 98-11-3 | 158.18 | C6H6O3S | NA | Benzenesulfonic Acid – API |
PA 02 12510 | Butyl Benzenesulfonate | IH | Butyl Besylate (Genotoxic Impurity); Benzenesulfonic Acid Butyl Ester; NSC 3215; | 25MG,50MG | NA | 80-44-4 | 214.28 | C10H14O3S | NA | Benzenesulfonic Acid – In house impurity |
PA 02 12520 | Ethyl Benzenesulfonate | IH | Ethyl Besylate (Genotoxic Impurity); Benzenesulfonic Acid Ethyl Ester; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 515-46-8 | 186.23 | C8H10O3S | Ethyl Phenylsulfonate; NSC 3217; Ethyl Besylate; | Benzenesulfonic Acid – In house impurity |
PA 02 12530 | Isopropyl Benzenesulfonate | IH | Isopropyl Besylate (Genotoxic Impurity); Benzenesulfonic Acid Isopropyl Ester; | 25MG,50MG | Refrigerator | 6214-18-2 | 200.25 | C9H12O3S | Benzenesulfonic Acid 1- Methylethyl Ester; Isopropyl Besylate; | Benzenesulfonic Acid – In house impurity |
PA 02 12540 | Methyl Benzenesulfonate | IH | Benzenesulfonic Acid Methyl Ester; Methyl Besylate; NSC 3214; 20ND3-5; | 25MG,50MG | Refrigerator | 80-18-2 | 172.2 | C7H8O3S | NA | Benzenesulfonic Acid – In house impurity |
PA 02 13000 | Benzhydrylamine | API | α-Phenyl-benzenemethanamine; 1- Amino-1-(phenylmethyl)benzene; | 25MG,50MG | NA | 91-00-9 | 183.25 | C13H13N | 1,1-Diphenylmethylamine; Aminodiphenylmethane; NSC 49127; | Benzhydrylamine – API |
PA 02 13510 | Benzhydrylaminoacetic Acid tert-Butyl Ester | IH | tertButyl(diphenylmethylamino)ethanoate; N- (Diphenylmethyl)glycine 1,1- Dimethylethyl Ester; | 25MG,50MG | NA | 158980-46-2 | 297.39 | C19H23NO2 | NA | Benzhydrylamine – In house impurity |
PA 02 13520 | 1-Benzhydrylazetidine | IH | 1-(Diphenylmethyl)azetidine; N- (Diphenylmethyl)azetidine; | 25MG,50MG | NA | 107128-00-7 | 223.31 | C16H17N | NA | Benzhydrylamine – In house impurity |
PA 02 13530 | 1-Benzhydrylazetidine-2-carboxylic Acid | IH | N-Benzhydryl-azetidine-2-carboxylic Acid; 1-(Diphenylmethyl)-2- azetidinecarboxylic Acid; | 25MG,50MG | NA | 65219-11-6 | 267.32 | C17H17NO2 | NA | Benzhydrylamine – In house impurity |
PA 02 13540 | 1-Benzhydrylazetidine-3-carboxylic Acid | IH | 1-(Diphenylmethyl)azetidine-3-carboxylic Acid; | 25MG,50MG | NA | 36476-87-6 | 267.32 | C17H17NO2 | NA | Benzhydrylamine – In house impurity |
PA 02 13550 | 1-Benzhydrylazetidin-3-ol | IH | 1-(Diphenylmethyl)-3-hydroxyazetinide; 1- (Diphenylmethyl)-3-azetidinol; | 25MG,50MG | Freezer | 18621-17-5 | 293.32 | C16H17NO | 1-(Diphenylmethyl)-3-azetidinol; NSC 319045; | Benzhydrylamine – In house impurity |
PA 02 14000 | Benzimidazole | API | ,3-Benzodiazole; BZI; 1H-Benzoimidazole; | 25MG,50MG | NA | 51-17-2 | 118.14 | C7H6N2 | NA | Benzimidazole – API |
PA 02 15000 | Benzocaine | API | 4-Aminobenzoic Acid Ethyl Ester; pAminobenzoic Acid Ethyl Ester; Ethyl 4- Aminobenzoate; Anaesthan-syngala; | 25MG,50MG | Refrigerator | 94-09-7 | 165.19 | C9H11NO2 | (p-(Ethoxycarbonyl)phenylamine; 4- (Ethoxycarbonyl)aniline; 4- (Ethoxycarbonyl)phenylamine; 4- Aminobenzoic Acid Ethyl Ester; 4- Carbethoxyaniline; Aethoform; Amben Ethyl Ester; Americaine; | Benzocaine – API |
PA 02 15510 | N-Acetylbenzocaine | IH | Ethyl 4-Acetamidobenzoate; 4’- Carbethoxyacetanilide; Ethyl 4- acetamidobenzoate; | 25MG,50MG | NA | 5338-44-3 | 207.23 | C10H11NO3 | Ethyl 4- acetylaminobenzoate; Ethyl N-acetyl-4-aminobenzoate; NSC 28987; NSC 3160 | Benzocaine – In house impurity |
PA 02 15520 | N-Formyl Benzocaine | IH | N-Formylbenzocaine; 4- (Formylamino)benzoic Acid Ethyl Ester; p-Formamidobenzoic Acid Ethyl Ester; | 25MG,50MG | NA | 5422-63-9 | 193.2 | C10H11NO3 | Ethyl 4- (Formylamino)benzoate; Ethyl 4- Formamidobenzoate; Ethyl p-Formamidobenzoate; | Benzocaine – In house impurity |
PA 02 15530 | Ethyl 4-Nitrobenzoate | IH | Ethyl 4-Nitrobenzoate; | 25MG,50MG | NA | 99-77-4 | 195.17 | C9H9NO4 | NA | Benzocaine – In house impurity |
PA 02 15540 | Benzocaine N-glucoside | IH | Benzocaine N-β-D-Glucoside; NGlucoanesthesin; 4-(β-Dglucopyranosylamino)benzoic Acid Ethyl Ester; | 25MG,50MG | NA | 28315-50-6 | 327.33 | C15H21NO7 | p-(β-Dglucopyranosylamino)benzoic Acid Ethyl Ester; Benzocaine NGlucoside; | Benzocaine – In house impurity |
PA 02 73000 | Benzothiadiazine | API | 2H-1,2,4-benzothiadiazine; 2Hbenzo[e][1,2,4]thiadiazine; | 25MG,50MG | NA | NA | 150.2 | C7H6N2S | NA | Benzothiadiazine – API |
PA 02 73510 | 4-Amino-6-chloro-1,3- benzenedisulfonamide | IH | 4-Amino-6-chloro-mbenzenedisulfonamide; 3-Chloro-4,6- disulfamoylaniline; 5-Chloro-2,4- disulfamoylaniline; | 25MG,50MG | Refrigerator | 121-30-2 | 285.73 | C6H8ClN3O4S2 | Chloraminophenamide; Chloroaminophenamide; Idorese; Salamid; Salamide; NSC 93772; Benzothiadiazine Related Compound A | Benzothiadiazine – In house impurity |
PA 02 83000 | Benzoyl Peroxide | API | Benzoic Peroxyanhydride; Hydrous Benzoyl Peroxide; Benzoyl Peroxide, Hydrous; Abcat 40; Acetoxyl; Acne-Aid Cream; Acnegel; Acnezoyl; Akneroxide L; Aksil 5; Aztec BP 50FT; B 75W; BP 50FT; BPO; BPO 50; Basiron; Benbel C; Benox 50; Benox A 80; Benoxyl; Benzac; Benzac W; Benzagel; Benzagel 10; Benzaknen; Benzashave; Benzoperoxide; Benzoyl Superoxide; Brevoxyl; C 1A; C 1A (peroxide); CH 50; CH 50L; |
25MG,50MG | Freezer | 94-36-0 | 242.23 | C14H10O4 | Cadet BPO; Cadet BPO 78W; Cadox 40E; Cadox B; Cadox B 40E; Cadox B 40ES; Cadox B 50P; Cadox B 75W; Cadox B-CH 50; Chaloxyd BP 50FT; Clear By Design; Debroxide; Degament H; Desanden; Desquam E; Desquam X; Dibenzoyl peroxide; Diphenylglyoxal peroxide; Dry and Clear; Epi-Clear; Fivenox B 50G; G 20; Interox BP 50P1; Interox GZS; Link-Cup DBP; Loroxide |
Benzoyl Peroxide – API |
PA 02 83030 | Ethyl Benzoate | Imp C | Ethyl Ester Benzoic Acid; Benzoyl Ethyl Ether; Ethyl Benzenecarboxylate; NSC 8884; | 25MG,50MG | Room Temp | 93-89-0 | 150.17 | C9H10O2 | NA | Benzoyl Peroxide – Impurity C |
PA 02 67000 | Benzthiazide | API | 6-Chloro-3-[[(phenylmethyl)thio]methyl]- 2H-1,2,4-benzothiadiazine-7- sulfonamide 1,1-Dioxide; 3- [(Benzylthio)methyl]-6-chloro-2H-1,2,4- benzothiadiazine-7-sulfonamide 1,1- Dioxide; | 25MG,50MG | Refrigerator | 91-33-8 | 431.94 | C15H14ClN3O4S3 | Aquatag; Benzothiazide; Dihydrex; Diucen; Diucene; Edemex; ExNa; Exosalt; Fovane; Freeuril; HyDrine; Lemazide; P 1393; Pfizer 1393; Proaqua; Regulon; Urese; | Benzthiazide – API |
PA 02 16000 | Benztropine Mesylate | API | Benzotropine Mesylate; Cogentin; Cogentinol; Benztropine methanesulfonate; | 25MG,50MG | Freezer | 132-17-2 | 403.53 | C22H29NO4S | (3-endo)-3-(Diphenylmethoxy)-8- methyl-8-azabicyclo[3.2.1]octane Methanesulfonate; | Benztropine Mesylate – API |
PA 02 17000 | Benzydamine Hydrochloride | API | N,N-Dimethyl-3-[[1-(phenylmethyl)-1Hindazol-3-yl]oxy]-1-propanamine Hydrochloride; Saniflor; Tamas; Tantum; Verax; 3-((1-Benzyl-1H-indazol-3-yl)oxy)- N,N-dimethylpropan-1-amine Hydrochloride; | 25MG,50MG | Refrigerator | 132-69-4 | 345.87 | C19H24ClN3O | 1-Benzyl-3-[3- (dimethylamino)propoxy]-1Hindazole Hydrochloride; Afloben; Alcidol; Andolex; Benalgin; Benciflam; Bendaminol; Benzyrin; Difflam; Difflam Cream; Dorinamin; Enzamin; Imotryl; Riripen; Salyzoron; | Benzydamine Hydrochloride – API |
PA 02 17010 | 3-Dimethylaminopropyl 2- benzylaminobenzoate Hydrochloride | Imp A | 3-(Dimethylamino)propyl 2- (benzylamino)benzoate Hydrochloride; 2- [(Phenylmethyl)amino]benzoic Acid 3- (Dimethylamino)propyl Ester Hydrochloride; | 25MG,50MG | NA | NA | 348.87 | C19H25ClN2O2 | NA | Benzydamine – Impurity A |
PA 02 17020 | 5-Benzyl Benzydamine | Imp B | 3-(1,5-Dibenzyl-1H-indazol-3- yl)oxypropyldimethylamine; 3-((1,5- Dibenzyl-1H-indazol-3-yl)oxy)-N,Ndimethylpropan-1-amine; | 25MG,50MG | Hygroscopic, Refrigerator, under inert atmosphere | NA | 399.53 | C26H29N3O | NA | Benzydamine – Impurity B (Freebase) |
PA 02 17021 | 5-Benzyl Benzydamine Hydrochloride | Imp B | 3-(1,5-Dibenzyl-1H-indazol-3- yl)oxypropyldimethylamine Hydrochloride |
25MG,50MG | Hygroscopic, Refrigerator, under inert atmosphere | NA | 435.99 | C26H30ClN3O | NA | Benzydamine – Impurity B (Hydrochloride) |
PA 02 17030 | 1-Benzyl-3-hydroxyindazole | Imp C | 1,2-Dihydro-1-(phenylmethyl)-3H-indazol3-one; 1-Benzyl-1,2-dihydro-3H-indazol3-one; 1-Benzyl-1H-indazol-3-ol; | 25MG,50MG | Refrigerator | 2215-63-6 | 224.26 | C14H12N2O | 1-Benzyl-1H-indazol-3-ol; 3- Hydroxy-1-benzyl-1H-indazole; 1- Benzyl-3-indazolone; NSC 247064; | Benzydamine – Impurity C |
PA 02 17510 | Benzydamine N-Oxide Hydrochloride | IH | 3-((1-Benzyl-1H-indazol-3-yl)oxy)-N,Ndimethylpropan-1-amine Oxide Hydrochloride; | 25MG,50MG | NA | 39860-94-1 | 361.87 | C19H24ClN3O2 | NA | Benzydamine – In house impurity |
PA 02 17520 | N,N-Dimethyl(3-chloropropyl)amine Hydrochloride | IH | 3-Chloro-N,N-dimethyl-1-propanamine Hydrochloride; (3- Chloropropyl)dimethylamine Hydrochloride; N-(3- Chloropropyl)dimethylamine | 25MG,50MG | Refrigerator | *5407-04-5 | 158.07 | C5H13Cl2N | 1-Chloro-3- (dimethylamino)propane Hydrochloride; 3-Chloro-N,Ndimethyl-1-propanamine Hydrochloride; N,N-Dimethyl-3- | Benzydamine – In house impurity |
PA 02 17530 | Benzyl 2-Acetamido-3-O-allyl-6-Obenzyl-2-deoxy-a-Dglucopyranoside | IH | 2-(Acetylamino)-2-deoxy-6-O- (phenylmethyl)-3-O-2-propen-1-ylα-D-glucopyranoside Phenylmethyl; | 25MG,50MG | NA | 60920-82-3 | 441.52 | C25H31NO6 | NA | Benzydamine – In house impurity |
PA 02 17540 | 1-Benzyl-3-hydroxy-1H-indazole Sodium Salt | IH | 1,2-Dihydro-1-(phenylmethyl)-3H-indazol3-one Sodium Salt; 1-Benzyl-1H-indazol3-ol Sodium Salt; 1-Benzyl-3-indazolone Sodium Salt; | 25MG,50MG | Refrigerator | 13185-09-6 | 246.24 | C14H11N2NaO | NA | Benzydamine – In house impurity |
PA 02 17550 | Demethyl Benzydamine Hydrochloride | IH | N-Methyl-3-[[1-(phenylmethyl)-1Hindazol-3-yl]oxy]-1-propanamine Hydrochloride; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere |
39860-97-4 | 331.84 | C18H22ClN3O | 1-Benzyl-3-(3- methylaminopropoxy)-1H-indazole Monohydrochloride; | Benzydamine – In house impurity |
PA 02 17560 | 3-Dimethylaminopropyl-2- benzylaminobenzoate | IH | 2-[(Phenylmethyl)amino]benzoic Acid 3- (Dimethylamino)propyl Ester; |
25MG,50MG | NA | 87453-76-7 | 312.41 | C19H24N2O2 | NA | Benzydamine – In house impurity |
PA 02 17570 | Benzydamine N-Oxide | IH | N,N-Dimethyl-3-[[1-(phenylmethyl)-1Hindazol-3-yl]oxy]-1-propanamine; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 36504-71-9 | 325.4 | C19H23N3O2 | NA | Benzydamine – In house impurity |
PA 02 18000 | Benzyl Alcohol | API | α-Toluenol; (Hydroxymethyl)benzene; Benzenecarbinol; | 25MG,50MG | Room Temp | 100-51-6 | 108.14 | C7H8O | Benzylic Alcohol; NSC 8044; Phenylcarbinol; Phenylmethanol; Phenylmethyl Alcohol; Sunmorl BK 20; TB 13G; α-Hydroxytoluene | Benzyl Alcohol – API |
PA 02 18020 | Cyclohexylmethanol | Imp B | (Hydroxymethyl)cyclohexane; Cyclohexanecarbinol; Cyclohexylcarbinol; | 25MG,50MG | NA | 100-49-2 | 114.19 | C7H14O | Cyclohexylmethanol; Cyclohexylmethyl alcohol; Hexahydrobenzyl alcohol; NSC 5288 | Benzyl Alcohol – Impurity B |
PA 02 19000 | Benzyl Benzoate | API | Benzyl Ester Benzoic Acid; Ascabin; Ascabiol; Benylate; Benzyl Benzenecarboxylate; Scobenol; Vanzoate; Venzonate; | 25MG,50MG | NA | 120-51-4 | 212.24 | C14H12O2 | Benzyl Benzoate; Benzyl Phenylformate; Benzylets; BenzyloxyPhenyl Ketone; Colebenz; NSC 8081; Nicca Sunsolt LM 7EX; Novoscabin; Pelemol B66; Peruscabin | Benzyl Benzoate – API |
PA 02 20000 | Benzyl Chloride | API | 6-(Chloromethyl)benzene; αChlorotoluene; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 100-44-7 | 126.58 | C7H7Cl | 1-Chloromethylbenzene; Benzyl Chloride; Chlorophenylmethane; NSC 8043; Phenylmethyl Chloride; Tolyl Chloride; ω-Chlorotoluene; | Benzyl Chloride – API |
PA 02 20510 | 2-Bromo-4-methoxybenzyl Chloride | IH | 2-Bromo-1-(chloromethyl)-4-methoxybenzene; 3-Bromo-4-(chloromethyl)- anisole; | 25MG,50MG | Freezer | 66916-97-0 | 235.51 | C8H8BrClO | NA | Benzyl Chloride – In house impurity |
PA 02 20520 | 4-Chlorobenzyl Chloride | IH | (4-Chlorophenyl)methyl Chloride; 1- (Chloromethyl)-4-chlorobenzene; 1- Chloro-4-(chloromethyl)benzene; α,pDichlorotoluene; α,4-Dichlorotoluene; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 104-83-6 | 161.03 | C7H6Cl2 | 4-Chloro-1- (chloromethyl)benzene; 4- Chlorobenzyl Chloride; 4- Chloromethyl chlorobenzene; NSC 34032; p,α-Dichlorotoluene; p | Benzyl Chloride – In house impurity |
PA 02 20530 | 2-Hydroxy-5-nitrobenzyl Chloride | IH | 2-(Chloromethyl)-4-nitrophenol; | 25MG,50MG | NA | 2973-19-5 | 187.58 | C7H6ClNO3 | NA | Benzyl Chloride – In house impurity |
PA 02 20540 | 1-Benzyl 4-[6-(5-Chloropyridin-2-yl)-7-oxo6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5- yl]piperazine-1,4-dicarboxylate | IH | 1,4-Piperazinedicarboxylic Acid 1-[6-(5- Chloro-2-pyridinyl)-6,7-dihydro-7-oxo-5Hpyrrolo[3,4-b]pyrazin-5-yl] 4- (Phenylmethyl) Ester; | 25MG,50MG | NA | 1076198-91-8 | 508.91 | C24H21ClN6O5 | NA | Benzyl Chloride – In house impurity |
PA 02 20550 | 1-Benzyl-3-(3-chloropropoxy)indazole | IH | 3-(3-Chloropropoxy)-1-(phenylmethyl)- 1H-indazole; | 25MG,50MG | Refrigerator | 13109-79-0 | 300.78 | C17H17ClN2O | NA | Benzyl Chloride – In house impurity |
PA 02 20560 | N-Benzyl Ciprofloxacin Benzyl Ester | IH | 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo7-(4-benzyl-1-piperazinyl)-3- quinolinecarboxylic Acid Benzyl Ester; | 25MG,50MG | Freezer | 1391052-64-4 | 511.59 | C31H30FN3O3 | NA | Benzyl Chloride – In house impurity |
PA 02 20570 | 1-Benzyl-3-cyanoacetyl Urea | IH | 2-Cyano-N- [[(phenylmethyl)amino]carbonyl]acetamid e; | 25MG,50MG | Freezer | 126245-46-3 | 217.22 | C11H11N3O2 | NA | Benzyl Chloride – In house impurity |
PA 02 20580 | Benzyl 4-Cyano-4-deoxy-2,3-O-[(1S,2S)- 1,2-dimethoxy-1,2-dimethyl-1,2- ethanediyl]-β-D-arabinopyranoside | IH | Phenylmethyl 4-Cyano-4-deoxy-2,3-O- [(1S,2S)-1,2-dimethoxy-1,2-dimethyl-1,2- ethanediyl]-β-D-arabinopyranoside; | 25MG,50MG | NA | 1084896-40-1 | 363.4 | C19H25NO6 | NA | Benzyl Chloride – In house impurity |
PA 02 20590 | 1-Benzyl-4-cyano-4-phenylpiperidine Hydrochloride | IH | 4-Phenyl-1-(phenylmethyl)-4- piperidinecarbonitrile Hydrochloride; 1- Benzyl-4-phenyl-4-piperidinecarbonitrile Hydrochloride; | 25MG,50MG | Refrigerator | 71258-18-9 | 312.84 | C19H21ClN2 | NA | Benzyl Chloride – In house impurity |
PA 02 20600 | S-Benzyl-L-cysteine Sulfone | IH | 3-[(Phenylmethyl)sulfonyl]-L-alanine; 3- (Benzylsulfonyl)-L-alanine; (R)-2-Amino3-(benzylsulfonyl)propanoic Acid; | 25MG,50MG | Freezer | 25644-88-6 | 243.28 | C10H13NO4S | NA | Benzyl Chloride – In house impurity |
PA 02 20610 | 8-O-Benzyl Debrisoquin Sulfate | IH | 8-O-Benzyl Debrisoquin Sulfate; | 25MG,50MG | NA | 1346604-07-6 | 330.39 | C17H19N3O•0.5H2S O4 | NA | Benzyl Chloride – In house impurity |
PA 02 20620 | 7-O-Benzyl Daidzein 4′-Tri-O-acetyl-β-Dglucuronic Acid Methyl Ester | IH | 3-(4-Benzyloxyphenyl)-4-oxo-4H-1- benzopyran-7-yl 4’-β-Dglucopyranosiduronic acid methyl ester 2,3,4-triacetate; | 25MG,50MG | NA | NA | 660.62 | C35H32O13 | NA | Benzyl Chloride – In house impurity |
PA 02 20630 | 3-O-Benzyl 15,16-Dehydro Estrone Monoethylene Ketal | IH | 3-(Phenylmethoxy)-estra-1,3,5(10),15- tetraen-17-one Cyclic 1,2-Ethanediyl Acetal; | 25MG,50MG | NA | 534572-67-3 | 402.53 | C27H30O3 | NA | Benzyl Chloride – In house impurity |
PA 02 20640 | N-Benzyl N-Demethyl Trimebutine | IH | 3,4,5-Trimethoxybenzoic Acid 2-(NBenzyl-methylamino)-2-phenylbutyl Ester; | 25MG,50MG | NA | 1329834-94-7 | 463.57 | C28H33NO5 | N-Benzyl NMonodesmethyltrimebutine | Benzyl Chloride – In house impurity |
PA 02 20650 | Benzyl 2-Deoxy-2-(2-carboxybenzimido)-3- O-benzyl-4,6-O-benzylidene-β-Dglucopyranoside | IH | Benzyl 2-Deoxy-2-(2-carboxybenzimido)- 3-O-benzyl-4,6-O-benzylidene-β-Dglucopyranoside; | 25MG,50MG | NA | NA | 595.64 | C35H33NO8 | NA | Benzyl Chloride – In house impurity |
PA 02 20660 | (4R)-Benzyl-4-deoxy-4-C-nitromethyl-β-Darabinopyranoside | IH | Phenylmethyl 4-Deoxy-4-(nitromethyl)-βD-arabinopyranoside; | 25MG,50MG | NA | 383173-71-5 | 283.28 | C13H17NO6 | NA | Benzyl Chloride – In house impurity |
PA 02 20670 | (4R,4S)-Benzyl-4-deoxy-4-C-nitromethyl-βD-arabinopyranoside | IH | Phenylmethyl 4-Deoxy-4-(nitromethyl)-βD-threo-pentopyranoside | 25MG,50MG | NA | 383173-66-8 | 283.28 | C13H17NO6 | NA | Benzyl Chloride – In house impurity |
PA 02 20680 | Benzyl 2-Deoxy-2-phthalimido-4,6-Obenzylidene-3-O-benzyl-β-Dglucopyranoside | IH | Phenylmethyl 2-Deoxy-2-(1,3-dihydro-1,3- dioxo-2H-isoindol-2-yl)-3-O- (phenylmethyl)-4,6-O-(phenylmethylene)- β-D-glucopyranoside; | 25MG,50MG | NA | 80035-34-3 | 577.62 | C35H31NO7 | NA | Benzyl Chloride – In house impurity |
PA 02 20690 | Benzyl 2-Deoxy-2-phthalimido-4-deoxy3,6-di-O-benzyl-β-D-glucopyranoside | IH | Benzyl 2-Deoxy-2-phthalimido-4-deoxy3,6-di-O-benzyl-β-D-glucopyranoside; | 25MG,50MG | NA | NA | 563.64 | C35H33NO6 | NA | Benzyl Chloride – In house impurity |
PA 02 22000 | Benzylpenicillin Benzathine | API | Benzathine Benzylpenicillin; N1,N2- Dibenzylethane-1,2-diamine bis((2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2- phenylacetamido)-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylate); | 25MG,50MG | NA | 1583-09-6 | 909.12 | C48H56N6O8S2 | NA | Benzylpenicillin Benzathine – API |
PA 02 22010 | Monobenzylethylendiamine | Imo A | 2-Benzylaminoethylamine; NBenzylethylenediamine; | 25MG,50MG | NA | *4152-09-4 | 150.22 | C9H14N2 | NA | Benzylpenicillin Benzathine – Impurity A |
PA 02 22020 | Phenylacetic Acid | Imp B | α-Tolylic acid; Benzeneacetic acid; PAA; Phenylacetic acid; | 25MG,50MG | NA | 103-82-2 | 136.15 | C8H8O2 | Tropicamide Imp. D (EP); Cyclopentolate Hydrochloride Imp. B (EP); Benzylpenicillin Benzathine Imp. B (EP); Benzylpenicillin Procaine Imp. E (EP); Benzylpenicillin Potassium Imp. B (EP); | Benzylpenicillin Benzathine – Impurity B |
PA 02 22030 | Benzylpenicilloic Acids Benzathide | Imp C | (4S)-2-(2-(Benzyl(2- (benzylamino)ethyl)amino)-2-oxo1-(2-phenylacetamido)ethyl)-5,5- dimethylthiazolidine-4-carboxylic Acid; | 25MG,50MG | NA | NA | 573.74 | C32H38N4O4S | NA | Benzylpenicillin Benzathine – Impurity C |
PA 02 22040 | Penillic Acid of Benzylpenicillin | Imp D | (3S,7R,7aR)-5-Benzyl-2,2- dimethyl-2,3,7,7atetrahydroimidazo[5,1-b]thiazole3,7- dicarboxylic Acid; | 25MG,50MG | NA | 13093-87-3 | 334.39 | C16H18N2O4S | NA | Benzylpenicillin Benzathine – Impurity D |
PA 02 22050 | Penicilloic Acid of Benzylpenicillin | Imp E | (4S)-2-(Carboxy(2- phenylacetamido)methyl)-5,5- dimethylthiazolidine-4-carboxylic Acid; | 25MG,50MG | NA | 11039-68-3 | 352.41 | C16H20N2O5S | NA | Benzylpenicillin Benzathine – Impurity E |
PA 02 22060 | (2RS,4S)-2- [[(Phenylacetyl)amino]methyl]-5,5- dimethylthiazolidine-4-carboxylic Acid | Imp F | Penilloic Acids of Benzylpenicillin; (2R,4S)-5,5-Dimethyl-2-((2- phenylacetamido)methyl)thiazolid ine-4-carboxylic Acid; | 25MG,50MG | NA | 501-34-9 | 308.4 | C15H20N2O3S | NA | Benzylpenicillin Benzathine – Impurity F |
PA 02 23000 | Benzylpenicillin Potassium | API | Benzyl Penicillinate Potassium Salt; (2S,5R,6R)-3,3-Dimethyl-7-oxo-6-[(2- phenylacetyl)amino]-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylic Acid Potassium Salt; Potassium Benzylpenicillin; Potassium |
25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 113-98-5 | 372.48 | C16H17KN2O4S | Potassium Penicillin G; Scotcil; Tabilin; Cosmopen; Cristapen; Crytapen; Eskacillin; Falapen; Forpen; Hipercilina; Hyasorb; Hylenta; M-Cillin; Monopen; NSC 131815; Notaral; Pentid; Pentids | Benzylpenicillin Potassium – API |
PA 02 23010 | 6-Aminopenicillanic Acid | Imp A | (+)-6-Aminopenicillanic Acid; (2S,5R,6R)- 6-Amino-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylic Acid; 6-APA; 6-APS; 6βAminopenicillanic acid; NSC 50071; | 25MG,50MG | Freezer 5 | 551-16-7 | 216.26 | C8H12N2O3S | [2S-(2α,5α,6β)]-6-Amino-3,3- dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2- carboxylic Acid; 6- Aminopenicillinate; Amoxicillin Related Compound A; | Benzylpenicillin Potassium – Impurity A |
PA 02 23020 | Phenylacetic acid | Imp B | α-Tolylic acid; Benzeneacetic acid; PAA; Phenylacetic acid; | 25MG,50MG | NA | 103-82-3 | 136.15 | C8H8O2 | Tropicamide Imp. D (EP); Cyclopentolate Hydrochloride Imp. B (EP); Benzylpenicillin Benzathine Imp. B (EP); Benzylpenicillin Procaine Imp. E (EP); Benzylpenicillin Potassium Imp. B (EP); | Benzylpenicillin Potassium – Impurity B |
PA 02 24000 | Benzylpenicillin Procaine Monohydrate | API | Procaine benzylpenicillin; (2S,5R,6R)-3,3- Dimethyl-7-oxo-6-[(phenylacetyl)amino]- 4-thia-1-azabicyclo[3.2.0]heptane-2- carboxylic Acid compd. with 2- (Diethylamino)ethyl 4-Aminobenzoate Hydrate; | 25MG,50MG | Refrigerator | 6130-64-9 | 588.72 | C29H40N4O7S | p-Aminohydratebenzoic Acid 2- (Diethylamino)ethyl Ester Mono[3,3-dimethyl-7-oxo-6-(2- phenylacetamido)-4-thia-1- azabicyclo[3.2.0]heptane-2- carboxylate] Monohydrate; Procaine Penicillin G Hydrate; | Benzylpenicillin Procaine Monohydrate – API |
PA 02 24010 | 4-Aminobenzoic Acid | Imp A | p-Aminobenzoic Acid; Bacterial Vitamin H1; p-Carboxyaniline; | 25MG,50MG | Refrigerator | 150-13-0 | 137.14 | C7H7NO2 | p-Carboxyphenylamine; Actipol; Amben; PABA; Pabacyd; Pabafilm; Trichochromogenic Factor; Vitamin BX; Vitamin H’; | Benzylpenicillin Procaine – Impurity A |
PA 02 24050 | Phenylacetic Acid | Imp E | α-Tolylic Acid; Benzeneacetic Acid; PAA; Phenylacetic Acid; | 25MG,50MG | NA | 103-82-2 | 136.15 | C8H8O2 | Tropicamide Imp. D (EP); Cyclopentolate Hydrochloride Imp. B (EP); Benzylpenicillin Benzathine Imp. B (EP); Benzylpenicillin Potassium Imp. B (EP); | Benzylpenicillin Procaine – Impurity E |
PA 02 25000 | Bepotastine Besylate | API | 4-[(S)-(4-Chlorophenyl)-2- pyridinylmethoxy]-1-piperidinebutanoic Acid Benzenesulfonate; Bepreve; TAU 284; Talion; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 190786-44-8 | 547 | C27H31ClN2O6S | (S)-4-[4-(4-Chlorophenyl-2- pyridylmethoxy)piperidinyl]butyric Acid Benzenesulfonate; BB; Bepotastine Benzenesulfonate; Bepotastine Benzenesulfonate Salt; Bepotastine Besilate; | Bepotastine Besylate – API |
PA 02 25510 | 2-[(S)-(4-Chlorophenyl)(4- piperidinyloxy)methyl]pyridine (2R,3R)-2,3- Dihydroxybutanedioate | IH | 2-[(S)-(4-Chlorophenyl)(4- piperidinyloxy)methyl]pyridine L-Tartrate; (S)-(-)-4-[(4-Chlorophenyl)(2- pyridyl)Methoxy]piperidine, L(+)tartaric Acid Salt; | 25MG,50MG | NA | 210095-58-2 | 452.89 | C21H25ClN2O7 | NA | Bepotastine Besylate – In house impurity |
PA 02 25520 | 4-[(S)-4-chlorophenyl-2-pyridinylmethoxy]- 1-piperidine butanoic Acid Ethyl Ester | IH | Bepotastine Ethyl Ester; (S)-Ethyl 4-(4- ((4-chlorophenyl)(pyridin-2- yl)methoxy)piperidin-1-yl)butanoate; (S)- 4-[4-(4-Chlorophenyl-2- pyridylmethoxy)piperidinyl]butyric Acid Ethyl Ester; | 25MG,50MG | NA | 190730-39-3 | 416.94 | C23H29ClN2O3 | (S)-4-[(4-Chlorophenyl)-2- pyridinylmethoxy]-1- piperidinebutanoic Acid Ethyl Ester; | Bepotastine Besylate – In house impurity |
PA 02 25530 | Bepotastine Besilate Racemic Mixture | IH | 4-(4-((4-Chlorophenyl)(pyridin-2- yl)methoxy)piperidin-1-yl)butanoic acid compound with benzenesulfonic Acid (1:1); 4-[(4- Chlorophenyl)-2- pyridinylmethoxy]-1- piperidinebutanoic Acid | 25MG,50MG | NA | NA | 547.06 | C27H31ClN2O6S | 4-[4-(4-Chlorophenyl-2- pyridylmethoxy)piperidinyl]b utyric Acid Benzenesulfonate | Bepotastine Besylate – In house impurity |
PA 02 26000 | Beraprost Sodium | API | dl-4-[(1R,2R,3aS,8bS)-2,3,3a,8bTetrahydro-2-hydroxy-[(3S,4RS)-3- hydroxy-4-methyl-oct-6-yne-(E)-1-enyl]-5- cyclopenta[b]benzofuranyl]butanoic Acid Sodium; | 25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphere | 88475-69-8 | 420.47 | C24H29NaO5 | MDL 201229; ML 1229; Dorner; Procylin; | Beraprost Sodium – API |
PA 02 27000 | Bergamottin | API | 4-[[(2E)-3,7-Dimethyl-2,6-octadien-1- yl]oxy]-7H-furo[3,2-g][1]benzopyran-7- one; | 25MG,50MG | Freezer | 7380-40-7 | 338.4 | C21H22O4 | (E)-4-[(3,7-dimethyl-2,6- octadienyl)oxy]-H-furo[3,2- g][1]benzopyran-7-one; 5- Geranoxypsoralen; Bergamotine; Bergaptin; | Bergamottin – API |
PA 02 27510 | 4-[[(2E)-6,7-Dihydroxy-3,7-dimethyl-2- octen-1-yl]oxy]-7H-furo[3,2- g][1]benzopyran-7-one; | IH | 6′,-7′-Dihydroxybergamottin; 6′,7′- Dihydroxy Bergamottin; | 25MG,50MG | NA | 145414-76-2 | 372.41 | C21H24O6 | NA | Bergamottin – In house impurity |
PA 02 91000 | Besifloxacin Hydrochloride | API | 7-[(3R)-3-Aminohexahydro-1Hazepin-1-yl]-8-chloro-1- cyclopropyl-6-fluoro-1,4-dihydro-4- oxo-3-quinolinecarboxylic Acid Hydrochloride; (R)-7-(3- Aminoazepan-1-yl)-8-chloro-1- cyclopropyl-6-fluoro-4-oxo-1,4- | 25MG,50MG | Refrigerat or | 405165-61-9 | 430.3 | C19H22Cl2FN3O3 | NA | Besifloxacin Hydrochloride – API |
PA 02 81000 | beta-Cyclodextrin Hydrate | API | Schardinger β-Dextrin Hydrate; Cycloheptaamylose; βSchardinger Dextrin; betaShardinger Dextrin; βCyclodextrin Hydrate; | 25MG,50MG | NA | 68168-23-0 | 1134.98 | C42H70O35•x(H2O) | NA | betaCyclodextrin Hydrate – API |
PA 02 81510 | β-Cyclodextrin Sulfobutyl Ethers Sodium Salts | IH | Betadex Sulfobutyl Ether Sodium; Betadex Sulfobutyl Ether Sodium Salt; Sulfobutyl Ether Beta Cyclodextrin Sodium; Beta-Cyclodextrin Sulfobutyl Ethers Sodium Salts; | 25MG,50MG | NA | 182410-00-0 | NA | 2H70O35•xNa•x(C4H9O | NA | beta-Cyclodextrin Hydrate – In house impurity |
PA 02 28000 | Betahistine Dihydrochloride | API | N-Methyl-2-pyridineethanamine Dihydrochloride; Sinmenier; Vasomota | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 5579-84-0 | 209.12 | C8H14Cl2N2 | 2-[2-(Methylamino)ethyl]pyridine Dihydrochloride; 2-[2- (Methylamino)ethyl]pyridine Dihydrochloride; Betaserc; PT 9; Serc; | Betahistine Dihydrochloride – API |
PA 02 29000 | Betahistine Hydrochloride | API | N-(Methyl-d3)-2-pyridineethanamine Hydrochloride; | 25MG,50MG | Hygroscopic, Store under Inert atmosphere Refrigerator | 15430-48-5 | 172.66 | C8H13ClN2 | 2-[2-(Methylamino)ethyl]pyridine Hydrochloride; [2-(2- Pyridyl)ethyl]methylamine Hydrochloride; | Betahistine Hydrochloride – API |
PA 02 29010 | 2-Vinylpyridine | Imp A | 2-Ethenylpyridine; 2-Pyridylethylene; NSC 18255; α-Vinylpyridine; | 25MG,50MG | NA | 100-69-6 | 105.14 | C7H7N | NA | Betahistine – Impurity A |
PA 02 29020 | 2-Pyridineethanol | Imp B | 2-(2-Hydroxyethyl)pyridine; 2-(2- Pyridinyl)ethanol; 2-(2-Pyridyl)ethanol | 25MG,50MG | Refrigerator | 103-74-2 | 123.15 | C7H9NO | 2-(2-Pyridyl)ethyl alcohol; 2-(αPyridyl)ethanol; 2-(βHydroxyethyl)pyridine; 2- Pyridylethanol; NSC 2144; NSC 77979; β-(2-Pyridyl)ethanol; | Betahistine – Impurity B |
PA 02 29030 | N-Methyl-2-(pyridine-2-yl)-N-[2-(pyridine-2- yl)ethyl]ethanamine Trihydrochloride | Imp C | N-Methyl-2-(pyridin-2-yl)-N-(2-(pyridin-2- yl)ethyl)ethanamine Trihydrochloride | 25MG,50MG | NA | NA | 350.71 | C15H22Cl3N3 | Betahistine Dihydrochloride Imp. C (EP) as Trihydrochloride; | Betahistine – Impurity C |
PA 02 30000 | Betaine | API | 1-Carboxy-N,N,N-trimethylMethanaminium Inner Salt; (Carboxymethyl)trimethylammonium Hydroxide Inner Salt; (Trimethylammonio)acetate; Abromine; Aminocoat; Aquadew AN 100; Betafin; Betafin BCR; Betafin BP; Betafin BP 20; Cystadane; | 25MG,50MG | Room Temp | 107-43-7 | 117.15 | C5H11NO2 | Betaine; Trimethylbetaine Glycine; Glycocoll Betaine; Glycylbetaine; Greenstim; Loramine AMB 13; Lycine; N,N,N-Trimethylglycine; Oxyneurine; Rubrine C; Trimethylbetaine;Trimethylglycocol l; α-Earleine; Fencaijian; FinnStim; Glycine; | Betaine – API |
PA 02 30510 | Betaine Aldehyde Chloride | IH | (Formylmethyl)trimethylammonium Chloride; | 25MG,50MG | Refrigerator | 7758-31-8 | 137.61 | C5H12ClNO | NA | Betaine – In house impurity |
PA 02 30520 | Betainealdehyde Diethylacetal Chloride | IH | 2,2-Diethoxy-N,N,N-trimethylethanaminium Chloride; | 25MG,50MG | NA | 110675-66-6 | 211.73 | C9H22ClNO | NA | Betaine – In house impurity |
PA 02 30530 | Betainealdehyde Diethylacetal Iodide | IH | 2,2-Diethoxy-N,N,N-trimethylethanaminium Iodide; (2,2- Diethoxyethyl)trimethylammonium Iodide; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 6711-89-3 | 303.18 | C9H22INO2 | NA | Betaine – In house impurity |
PA 02 30540 | Betaine Hydrochloride | IH | N-(Carboxymethyl)-N,N,Ntrimethylammonium Chloride; Pluchine; Acidol; | 25MG,50MG | NA | 590-46-5 | 153.61 | C5H12ClNO2 | NA | Betaine – In house impurity |
PA 02 31000 | Betamethasone | API | (11β,16β)-9-Fluoro-11,17,21-trihydroxy16-methylpregna-1,4-diene-3,20-dione; | 25MG,50MG | Freezer | 378-44-9 | 392.46 | C22H29FO5 | 9α-Fluoro-16βmethylprednisolone; Betadexamethasone; Flubenisolone; Sch-4831; NCS39470; | Betamethasone – API |
PA 02 31010 | Dexamethasone | Imp A | (11β,16α)-9-Fluoro-11,17,21-trihydroxy16-methylpregna-1,4-diene-3,20-dione; 16α-Methyl-9α-fluoroprednisolone; | 25MG,50MG | Freezer | 50-02-2 | 392.46 | C22H29FO5 | Aeroseb-Dex; Corson; Cortisumman; Decacort; Decaderm; Decadron; Decalix; Decasone; Dekacort; | Betamethasone – Impurity A |
PA 02 31020 | Clobetasol | Imp B | (11β,16β)-21-Chloro-9-fluoro-11,17- dihydroxy-16-methylpregna-1,4-diene3,20-dione; 21-Chloro-9-fluoro-11β,17- dihydroxy-16β-methylpregna-1,4-diene3,20-dione; | 25MG,50MG | Freezer | 25122-41-2 | 410.91 | C22H28ClFO4 | NA | Betamethasone – Impurity B |
PA 02 31030 | 17,21-Dihydroxy-16β-methylpregna1,4,9(11)-triene-3,20-dione | Imp c | (8S,10S,13S,14S,16S,17R)-17-Hydroxy17-(2-hydroxyacetyl)-10,13,16-trimethyl6,7,8,10,12,13,14,15,16,17-decahydro3H-cyclopenta[a]phenanthren-3-one | 25MG,50MG | NA | 13504-15-9 | 356.46 | C22H28O4 | (16β)-17,21-Dihydroxy-16β-methylpregna-1,4,9(11)-triene-3,20- dione; | Betamethasone – Impurity C |
PA 02 31040 | 9-Fluoro-11β,17-dihydroxy-16β-methyl3,20-dioxopregna-1,4-dien-21-yl ethoxycarboxylate | Imp D | Ethyl (2- ((8S,9R,10S,11S,13S,14S,16S,17R)-9- Fluoro-11,17-dihydroxy-10,13,16- trimethyl-3-oxo6,7,8,9,10,11,12,13,14,15,16,17- dodecahydro-3Hcyclopenta[a]phenanthren-17-yl)-2- oxoethyl) Carbonate; | 25MG,50MG | NA | 52619-05-3 | 464.52 | C25H33FO7 | NA | Betamethasone – Impurity D |
PA 02 31060 | 17,21-Dihydroxy-16β-methylpregna-1,4,11- triene-3,20-dione | Imp F | (8S,9S,10R,13S,14S,16S,17R)-17- Hydroxy-17-(2-hydroxyacetyl)-10,13,16- trimethyl-6,7,8,9,10,13,14,15,16,17- decahydro-3H-cyclopenta[a]phenanthren3-one; 9-Desfluoro-11-deshydroxy-11,12- dehydro Betamethasone; | 25MG,50MG | NA | 330157-04-5 | 356.46 | C22H28O4 | (16β)-17,21-Dihydroxy-16-methylPregna-1,4,11-triene-3,20-dione; (8S,9S,10R,13S,14S,16S,17R)-17- Hydroxy-17-(2-hydroxyacetyl)- 10,13,16-trimethyl6,7,8,9,10,13,14,15,16,17- decahydro-3Hcyclopenta[a]phenanthren-3-one | Betamethasone – Impurity F |
PA 02 31070 | 11α,17,21-Trihydroxy-16βmethylpregna-1,4-diene-3,20- dione | Imp G | 11a,17,21-trihydroxy-16bmethylpregna-1,4-diene-3,20- dione; 1,4-Diene-3,20-dione, 11α,17,21-trihydroxy-16βmethylpregna-; | 25MG,50MG | NA | 85700-75-0 | 374.47 | C22H30O5 | (8S,9S,10R,11R,13S,14S,1 6S,17R)-11,17-Dihydroxy-17- (2-hydroxyacetyl)-10,13,16- trimethyl6,7,8,9,10,11,12,13,14,15,1 6,17-dodecahydro-3Hcyclopenta[a]phenanthren-3 | Betamethasone – Impurity G |
PA 02 31510 | Betamethasone-∆17,20 21-Aldehyde | IH | (11β,16β)-9-Fluoro-11,20-dihydroxy-16- methyl-3-oxo-pregna-1,4,17(20)-trien-21- al; | 25MG,50MG | Freezer, Under Inert Atmosphere | 6762-45-4 | 374.45 | C22H27FO4 | NA | Betamethasone – In house impurity |
PA 02 31520 | Betamethasone β-D-Glucuronide Sodium Salt |
IH | (11β,16β)-9-Fluoro-11,17-dihydroxy-16- methyl-3,20-dioxopregna-1,4-dien-21-yl β-D-Glucopyranosiduronic Acid Sodium Salt; | 25MG,50MG | Freezer | 105088-07-1 | 590.57 | C28H36FNaO11 | NA | Betamethasone – In house impurity |
PA 02 31530 | Betamethasone 17-Propionate | IH | (11β,16β)-9-Fluoro-11,21-dihydroxy-16- methyl-17-(1-oxopropoxy)pregna-1,4- diene-3,20-dione; | 25MG,50MG | Refrigerator | 5534-13-4 | 448.52 | C25H33FO6 | Betamethasone 17α-Propionate; | Betamethasone – In house impurity |
PA 02 31540 | Betamethasone 9,11-Epoxide | IH | (9β,11β,16β)-9,11-Epoxy-17,21- dihydroxy-16-methylpregna-1,4-diene3,20-dione; | 25MG,50MG | Refrigerator | 981-34-0 | 372.45 | C22H28O5 | 9β,11β-Epoxy-17,21-dihydroxy16β-methylpregna-1,4-diene-3,20- dione; | Betamethasone – In house impurity |
PA 02 31550 | Betamethasone 21-Acetate 17-Propionate | IH | (11β,16β)-21-(Acetyloxy)-9-fluoro-11- hydroxy-16-methyl-17-(1- oxopropoxy)pregna-1,4-diene-3,20- dione; | 25MG,50MG | Freezer, Under Inert Atmospher | 5514-81-8 | 490.56 | C27H35FO7 | 9-Fluoro-11β,17,21-trihydroxy-16βmethylpregna-1,4-diene- 3,20- dione 21-Acetate 17-Propionate; | Betamethasone – In house impurity |
PA 02 31560 | Betamethasone 9,11-Epoxide 21- Propionate | IH | (9β,11β,16β)-9,11-Epoxy-17-hydroxy-16- methyl-21-(1-oxopropoxy)pregna-1,4- diene-3,20-dione; | 25MG,50MG | Refrigerator | 205105-83-5 | 428.52 | C25H32O6 | Beclomethasone 9,11-Epoxide 21- Propionate; | Betamethasone – In house impurity |
PA 02 31570 | Betamethasone Tripropionate | IH | (11β,16β)-9-Fluoro-16-methyl-11,17,21- tris(1-oxopropoxy)pregna-1,4-diene-3,20- dione; | 25MG,50MG | Freezer | 1186048-33-8 | 560.65 | C31H41FO8 | Betamethasone 11,17,21- Tripropionate; | Betamethasone – In house impurity |
PA 02 31580 | Betamethasone 17-Propionate 21- Ethoxide | IH | 21-O-Ethyl-17-Opropionylbetamethasone; Betamethasone 17-Propionate 21- Ethoxide; FT-0663091; | 25MG,50MG | Freezer | 123013-29-6 | 476.58 | C27H37FO6 | NA | Betamethasone – In house impurity |
PA 02 31590 | Betamethasone 17-Propionate 21- Mesylate | IH | (11β,16β)-9-Fluoro-11-hydroxy-16- methyl-21-[(methylsulfonyl)oxy]-17-(1- oxopropoxy)pregna-1,4-diene-3,20- dione; | 25MG,50MG | NA | 15423-80-0 | 526.61 | 9-Fluoro-11β,17,21-trihydroxy-16βmethylpregna-1,4-diene-3,20- dione 21-Methanesulfonate 17- Propionate; | Betamethasone – In house impurity | |
PA 02 31600 | Betamethasone 17-Valerate | IH | (11β,16β)-9-Fluoro-11,21-dihydroxy-16- methyl-17-[(1-oxopentyl)oxy]pregna-1,4- diene-3,20-dione; 9-Fluoro-11β,17,21- trihydroxy-16β-methylpregna-1,4-diene3,20-dione 17-Valerate; 9α-Fluoro-16βmethylprednisolone 17-Valerate; Rinderon V; Stanoval; Tokuderm; Valisone; β-Methasone 17-Valerate; |
25MG,50MG | Refrigerator | 2152-44-5 | 476.58 | C27H37FO6 | 9α-Fluoro-11β,21-dihydroxy-16βmethyl-17α-valeryloxypregna-1,4- diene-3,20-dione; Bedermin; Betamethasone 17α-Valerate; Betnesol V; Betneval; Betnovate; Betnovateat; Betoid; Celestan V; Celestane V; Celestoderm; Celestoderm V; Celeston valerate | Betamethasone – In house impurity |
PA 02 31610 | Betamethasone 21-Valerate | IH | (11β,16β)-9-Fluoro-11,17-dihydroxy-16- methyl-21-[(1-oxopentyl)oxy]pregna-1,4- diene-3,20-dione; 9-Fluoro-11β,17,21- trihydroxy-16β-methylpregna-1,4-diene3,20-dione 21-Valerate; | 25MG,50MG | Freezer | 2240-28-0 | 476.58 | C27H37FO7 | Betamethasone Related Compound A; | Betamethasone – In house impurity |
PA 02 31620 | Clobetasol 17-Propionate | IH | (11β,16β)-21-Chloro-9-fluoro-11-hydroxy16-methyl-17-(1-oxopropoxy)pregna-1,4- diene-3,20-dione; | 25MG,50MG | Freezer | 25122-46-7 | 466.97 | C25H32ClFO5 | 21-Chloro-21- deoxybetamethasone 17- Propionate; Clobederm; Clobesol; Clobex; Dermoval; Dermovate; Dermoxin; Dermoxinale; GR 2/925; Karison; Olux; Skin Cap; Temovate; | Betamethasone – In house impurity |
PA 02 31630 | 21-Dehydro Betamethasone 17-Valerate | IH | 9α-Fluoro-11β-hydroxy-16β-methyl-17αvaleryloxy-3,20-dioxopregna-1,4-dien-21- al; | 25MG,50MG | NA | NA | 474.56 | C27H35FO6 | NA | Betamethasone – In house impurity |
PA 02 31640 | 21-Dehydro Betamethasone | IH | (11β,16β)-9-Fluoro-11,17-dihydroxy-16- methyl-3,20-dioxopregna-1,4-dien-21-al; | 25MG,50MG | NA | 61558-12-1 | 390.45 | C22H27FO5 | NA | Betamethasone – In house impurity |
PA 02 31650 | 21-Dehydro Betamethasone 17- Propionate | IH | (11β,16β)- 9-Fluoro-11-hydroxy-16- methyl-3,20-dioxo-17-(1- oxopropoxy)pregna-1,4-dien-21-al; | 25MG,50MG | NA | NA | 446.51 | C25H31FO6 | NA | Betamethasone – In house impurity |
PA 02 31660 | 1,2-Dihydro Betamethasone 9,11-Epoxide 17,21-Dipropionate | IH | 9β,11β,16β)-9,11-Epoxy-16-methyl17,21-bis(1-oxopropoxy)pregna-4-ene3,20-dione; | 25MG,50MG | NA | NA | 486.6 | C28H38O7 | NA | Betamethasone – In house impurity |
PA 02 31670 | Hydrocortisone 17-Propionate 21-Acetate | IH | (11β)-21-(Acetyloxy)-11-hydroxy-17-(1- oxopropoxy)pregn-4-ene-3,20-dione; | 25MG,50MG | Refrigerator | 74050-20-7 | 460.56 | C26H36O7 | Cortisol 17-Propionate 21- Acetate; Hydrocortisone Aceponate; | Betamethasone – In house impurity |
PA 02 32000 | Betamethasone Acetate | API | Betamethasone 21-Acetate; (11β,16β)- 21-(Acetyloxy)-9-fluoro-11,17-dihydroxy16-methylpregna-1,4-diene-3,20-dione; | 25MG,50MG | Refrigerator | 987-24-6 | 434.5 | C24H31FO6 | 9-Fluoro-11β,17,21-trihydroxy-16βmethylpregna-1,4-diene-3,20- dione 21-acetate; Betamethasone Acetate; | Betamethasone Acetate – API |
PA 02 32010 | Betamethasone | Imp A | (11β,16β)-9-Fluoro-11,17,21-trihydroxy16-methylpregna-1,4-diene-3,20-dione; 9α-Fluoro-16β-methylprednisolone; | 25MG,50MG | Freezer | 378-44-9 | 392.46 | C22H29FO5 | Betadexamethasone; Flubenisolone; Sch-4831; NCS39470; | Betamethasone Acetate – Impurity A |
PA 02 33000 | Betamethasone Dipropionate | API | (11β,16β)-9-Fluoro-11-hydroxy-16- methyl-17,21-bis(1-oxopropoxy)-pregna1,4-diene-3,20-dione; | 25MG,50MG | Freezer | 5593-20-4 | 504.59 | C28H37FO7 | Betamethasone 17,21- Dipropionate; Diproderm; Diprolene; Diprophos; Diprosis; Diprosone; Diprospan; Maxivate; Psorion; Rinderon DP; S 3440; Sch 11460; β-Methasone 17,21- dipropionate; | Betamethasone Dipropionate – API |
PA 02 33010 | Betamethasone | Imp A | (11β,16β)-9-Fluoro-11,17,21-trihydroxy16-methylpregna-1,4-diene-3,20-dione; | 25MG,50MG | Freezer | 378-44-9 | 392.46 | C22H29FO5 | 9α-Fluoro-16βmethylprednisolone; Betadexamethasone; Flubenisolone; Sch-4831; NCS39470; | Betamethasone Dipropionate – Impurity A |
PA 02 33030 | Betamethasone 21-Propionate I | Imp C | (11β,16β)-9-Fluoro-11,17-dihydroxy-16- methyl-21-(1-oxopropoxy)pregna-1,4- diene-3,20-dione | 25MG,50MG | Refrigerator | 75883-07-7 | 448.52 | C25H33FO6 | NA | Betamethasone Dipropionate – Impurity C |
PA 02 33050 | Beclomethasone Dipropionate | Imp E | 9α-Chloro-16β-methylprednisolone 17,21-dipropionate; Aerobec; | 25MG,50MG | Freezer | *5534-09-8 | 521.04 | C28H37ClO7 | Aldecin; Beclometasone Dipropionate; Beclotide; Clenil A; Entyderma; QVAR; Sanasthmax; Viarox; Ventolair; | Betamethasone Dipropionate – Impurity E |
PA 02 33060 | Betamethasone 9,11-Epoxide 17,21-Dipropionate | Imp F | 9β,11β-Epoxy Betamethasone Dipropionate; 9,11β-Epoxy-16βmethyl-3,20-dioxo-9β-pregna-1,4- diene-17,21-diyl Dipropanoate; (9β,11β,16β)-9,11-Epoxy-16- methyl-17,21-bis(1- oxopropoxy)pregna-1,4-diene3,20-dione; | 25MG,50MG | Refrigerator | 66917-44-0 | 484.58 | C28H36O7 | Beclomethasone 9,11- Epoxide 17,21-Dipropionate; Betamethasone 9β,11βepoxide 17,21-Dipropionate; Beclomethasone 9,11- Epoxide 17,21-Dipropionate | Betamethasone Dipropionate – Impurity F |
PA 02 34000 | Betamethasone Sodium Phosphate | API | Betamethasone 21-Phosphate Disodium Salt; (11β,16β)-9-Fluoro-11,17- dihydroxy-16-methyl-21- (phosphonooxy)pregna-1,4-diene-3,20- dione Sodium Salt; | 25MG,50MG | NA | 151-73-5 | 516.4 | C22H28FNa2O8P | 9-Fluoro-11β,17,21-trihydroxy-16βmethylpregna-1,4-diene -3,20- dione 21-(Dihydrogen Phosphate) Sodium Salt; Betnesol; Durabetason; NSC 90616; Steronema; Vista-Methasone | Betamethasone Sodium Phosphate – API |
PA 02 89000 | Betamethasone Valerate | API | Betamethasone 17-Valerate; 9- Fluoro-11β,21-dihydroxy-16βmethyl-3,20-dioxopregna-1,4-dien17-yl Pentanoate; (11β,16β)-9- Fluoro-11,21-dihydroxy-16-methyl17-[(1-oxopentyl)oxy]pregna-1,4- diene-3,20-dione; 9-Fluoro11β,17,21-trihydroxy-16βmethylpregna-1,4-diene-3,20 | 25MG,50MG | Refrigerator | 2152-44-5 | 476.58 | C27H37FO6 | 9α-Fluoro-11β,21-dihydroxy16β-methyl-17αvaleryloxypregna-1,4-diene3,20-dione; Bedermin; Betamethasone 17αValerate; Betnesol V; Betneval; Betnovate; Betnovateat; Betoid; Celestan V; Celestane V | Betamethasone Valerate – API |
PA 02 89020 | 21-Deoxy-betamethasone | Imp B | Doxybetasol; 9-Fluoro-11β,17- dihydroxy-16β-methylpregna-1,4- diene-3,20-dione; 21- Deoxybetamethasone; 9-Fluoro11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione | 25MG,50MG | NA | 1879-77-2 | 376.46 | C22H29FO4 | (8S,9R,10S,11S,13S,14S,16 S,17R)-17-Acetyl-9-fluoro11,17-dihydroxy-10,13,16- trimethyl6,7,8,9,10,11,12,13,14,15,1 6,17-dodecahydro-3H | Betamethasone Valerate – Impurity B |
PA 02 89030 | Dexamethasone 17-Valerate | Imp C | Dexamethasone Valerate; 9- Fluoro-11β,21-dihydroxy-16αmethyl-3,20-dioxopregna1,4-dien17-yl Pentanoate; DV 17; 9- Fluoro-11β,17,21-trihydroxy-16αmethyl-pregna-1,4-diene-3,20- dione 17-Valerate; | 25MG,50MG | NA | 33755-46-3 | 476.58 | C27H37FO6 | (8S,9R,10S,11S,13S,14S,16 R,17R)-9-Fluoro-11-hydroxy17-(2-hydroxyacetyl)- 10,13,16-trimethyl-3-oxo6,7,8,9,10,11,12,13,14,15,1 6,17-dodecahydro-3Hcyclopenta[a]phenanthren | Betamethasone Valerate – Impurity C |
PA 02 89040 | 9-Bromo-betamethasone Valerate | Imp D | 9-Bromo-11β,21-dihydroxy-16βmethyl-3,20-dioxopregna-1,4-dien17-yl pentanoate; (8S,9R,10S,11S,13S,14S,16S,17 R)-9-Bromo-11-hydroxy-17-(2- hydroxyacetyl)-10,13,16-trimethyl3-oxo6,7,8,9,10,11,12,13,14,15,16,17- | 25MG,50MG | NA | NA | 537.48 | C27H37BrO6 | NA | Betamethasone Valerate – Impurity D |
PA 02 89060 | Betamethasone Valerate Δ-9(11) I | Imp F | Betamethasone 9(11)-ene; Betamethasone Valerate δ-9(11); 21-Hydroxy-16β-methyl-3,20- dioxopregna-1,4,9(11)-trien-17-yl Pentanoate; 17,21-Dihydroxy-16βmethyl-pregna-1,4,9(11)-triene3,20-dione 17-Valerate; | 25MG,50MG | NA | 16125-28-3 | 440.57 | C27H36O5 | (8S,10S,13S,14S,16S,17R)- 17-(2-Hydroxyacetyl)- 10,13,16-trimethyl-3-oxo6,7,8,10,12,13,14,15,16,17- decahydro-3Hcyclopenta[a]phenanthren17-yl Pentanoate; | Betamethasone Valerate – Impurity F |
PA 02 89070 | 6α-Bromo-betamethasone Valerate | Imp G | 6α-Bromo-9-fluoro-11β,21- dihydroxy-16βmethyl-3,20- dioxopregna-1,4-dien-17-yl Pentanoate; Betamethasone 6αBromo 17-Valerate; | 25MG,50MG | NA | NA | 555.47 | C27H36BrFO6 | (6S,8S,9R,10S,11S,13S,14 S,16S,17R)-6-Bromo-9- fluoro-11-hydroxy-17-(2- hydroxyacetyl)-10,13,16- trimethyl-3-oxo6,7,8,9,10,11,12,13,14,15,1 6,17-dodecahydro-3Hcyclopenta[a]phenanthren | Betamethasone Valerate – Impurity G |
PA 02 89080 | Beclomethasone 17-Valerate | Imp H | 9-Chloro-11β,21-dihydroxy-16βmethyl-3,20-dioxopregna1,4-dien17-yl Pentanoate; (11β,16β)-9- Chloro-11,21-dihydroxy-16- methyl-17-[(1-oxopentyl)oxy]- pregna-1,4-diene-3,20-dione; | 25MG,50MG | NA | 52619-18-8 | 493.03 | C27H37ClO6 | (8S,9R,10S,11S,13S,14S,16 S,17R)-9-Chloro-11-hydroxy17-(2-hydroxyacetyl)- 10,13,16-trimethyl-3-oxo6,7,8,9,10,11,12,13,14,15,1 6,17-dodecahydro-3Hcyclopenta[a]phenanthren | Betamethasone Valerate – Impurity H |
PA 02 89090 | 9-Fluoro-prednisolone 17-valerate I | Imp I | 9-Fluoro-11β,21-dihydroxy-3,20- dioxopregna-1,4-dien-17-yl Pentanoate; 9αFluoroprednisolone 17-Valerate; 9-Fluoro-11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 17- valerate; 9-Fluoro-11β,17,21- | 25MG,50MG | NA | 2802-10-0 | 462.55 | C26H35FO6 | (8S,9R,10S,11S,13S,14S,17 R)-9-Fluoro-11-hydroxy-17- (2-hydroxyacetyl)-10,13- dimethyl-3-oxo6,7,8,9,10,11,12,13,14,15,1 6,17-dodecahydro-3Hcyclopenta[a]phenanthren | Betamethasone Valerate – Impurity I |
PA 02 35000 | Betaxolol Hydrochloride | API | 1-[4-[2- (Cyclopropylmethoxy)ethyl]phenoxy]-3- [(1-methylethyl)amino]-2-propanol Hydrochloride; | 25MG,50MG | NA | 63659-19-8 | 343.89 | C18H30ClNO3 | Betapress; Betaxolol Hydrochloride; Betoptic; Betoptima; Kerlone; Optipress; SL 75212; SLD 212 | Betaxolol Hydrochloride – API |
PA 02 35010 | (2RS)-1-(4- Ethylphenoxy)-3-[(1- methylethyl)amino]- propan-2-ol Hydrochloride | Imp A | Des[4-(2-cyclopropylmethoxy)] Betaxolol Hydrochloride; (2RS)-1-(4-Ethylphenoxy)- 3-[(1-methylethyl)amino]-2-propanol Hydrochloride; | 25MG,50MG | NA | 464877-45-0 | 273.8 | C14H24ClNO2 | NA | Betaxolol – Impurity A |
PA 02 35020 | 0 (2RS)-1-[4-(2-Hydroxyethyl)-phenoxy]-3- [(1-methylethyl)amino]propan-2-ol | Imp B | O-Desmethyl Metoprolol; 4-[2-Hydroxy-3- [(1-methylethyl)amino]propoxy]- benzeneethanol; | 25MG,50MG | Freezer | 62572-94-5 | 253.34 | C14H23NO3 | (+/-)-4-[2-Hydroxy-3- (isopropylamino)propoxy]phenyleth yl Alcohol; (+/-)-ODemethylmetoprolol; H 105/22; SL 80-0088; | Betaxolol – Impurity B |
PA 02 35030 | 2-[[4-[2- (cyclopropylmethoxy)ethyl]phenoxy]methyl ]oxirane | Imp C | [[4-[2- (Cyclopropylmethoxy)ethyl]phenoxy]met hyl]oxirane; | 25MG,50MG | NA | 63659-17-6 | 248.32 | C15H20O3 | NA | Betaxolol – Impurity C |
PA 02 35040 | 4-[2-(Cyclopropylmethoxy)ethyl]phenol | Imp D | 4-[2-(Cyclopropylmethoxy)ethyl]phenol | 25MG,50MG | Refrigerat or | 63659-16-5 | 192.25 | C12H16O2 | NA | Betaxolol – Impurity D |
PA 02 35050 | O-Des(cyclopropylmethyl)-O-butyl Betaxolol Hydrochloride | Imp E | (2RS)-1-[4-(2-Butoxyethyl)phenoxy]-3-[(1- methylethyl)amino]propan-2-ol Hydrochloride; | 25MG,50MG | NA | 1329613-85-5 | 345.9 | C18H32ClNO3 | 1-(4-(2-Butoxyethyl)phenoxy)-3- (isopropylamino)propan-2-ol Hydrochloride; | Betaxolol – Impurity E |
PA 02 66000 | Bezafibrate | API | 2-[4-[2-[(4- Chlorobenzoyl)amino]ethyl]phenoxyl]-2- methylpropanoic Acid; BM-15075; | 25MG,50MG | Refrigerat or | 41859-67-0 | 361.82 | C19H20ClNO4 | Befizal; Bezalip; Bezatol; Cedur; Difaterol; | Bezafibrate – API |
PA 02 66010 | 4-Chloro-N-[2-(4- hydroxyphenyl)ethyl]benzamide | Imp A | N-(4-Chlorobenzoyl)tyramine | 25MG,50MG | Refrigerat or | 41859-57-8 | 275.73 | 0C15H14ClNO2 | NA | Bezafibrate – Impurity A |
PA 02 66020 | 4-Chlorobenzoic Acid | Imp B | p-Chlorobenzoic Acid; 4-CBA; Mycosid; NSC 143358; NSC 32738; NSC 8444; pCarboxychlorobenzene; | 25MG,50MG | NA | 74-11-3 | 156.57 | C7H5ClO2 | p-Chlorbenzoic Acid; pChlorobenzoic Acid; Indometacin impurity A; | Bezafibrate – Impurity B |
PA 02 66030 | Methyl 2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]-2- methylpropanoate | Imp C | Methyl 2-(4-(2-(4- Chlorobenzamido)ethyl)phenoxy)- 2-methylpropanoate; | 25MG,50MG | NA | NA | 375.85 | C20H22ClNO4 | NA | Bezafibrate – Impurity C |
PA 02 66040 | Ethyl 2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]-2- methylpropanoate | Imp D | Ethyl 2-(4-(2-(4- Chlorobenzamido)ethyl)phenoxy)-2- methylpropanoate; | 25MG,50MG | NA | 41859-58-9 | 389.87 | C21H24ClNO4 | NA | Bezafibrate – Impurity D |
PA 02 66050 | Butyl 2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]-2- methylpropanoate | Imp E | Butyl 2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]-2- methylpropanoate; | 25MG,50MG | NA | NA | 417.03 | C23H28ClNO4 | NA | Bezafibrate – Impurity E |
PA 02 66510 | 0 N,O-Bis-(4-chlorobenzoyl)tyramine | IH | 4-(2-(4- Chlorobenzamido)ethyl)phenyl 4- chlorobenzoate; | 25MG,50MG | NA | 41859-56-7 | 414.28 | C22H17Cl2NO3 | NA | Bezafibrate – In house impurity |
PA 02 36000 | Bicalutamide | API | N-[4-Cyano-3-trifluoromethyl)phenyl]-3- [(4-fluorophenyl)sulfonyl]- 2-hydroxy-2- methylpropanamide; | 25MG,50MG | Freezer | 90357-06-5 | 430.37 | C18H14F4N2O4S | ICI-176334; Casodex; Cosudex; ICI 176334; ZD 176334 | Bicalutamide – API |
PA 02 36010 | Desfluoro Bicalutamide | Imp A | (RS)-N-[4-Cyano-3- (trifluoromethyl)phenyl]-3-phenyl sulfonyl2-hydroxy-2-methyl-propanamide; | 25MG,50MG | Refrigerato | 90357-05-4 | 412.38 | C18H15F3N2O4S | (+/-)-N-[4-Cyano-3- (trifluoromethyl)phenyl]-2-hydroxy2-methyl-3- (phenylsulfonyl)propanamide; | Bicalutamide – Impurity A |
PA 02 36020 | Bicalutamide 2-Fluoro Isomer | Imp B | 2-Fluoro-4-desfluoro Bicalutamide; (RS)- 4-Cyano-3-(2-fluorophenylsulfonyl)-2- hydroxy-2-methyl-3-(trifluoromethyl)- propionanilide; | 25MG,50MG | NA | 1159977-36-2 | 430.37 | C18H14F4N2O4S | N-[4-Cyano-3- trifluoromethyl)phenyl]-3-[(2- fluorophenyl)sulfonyl]-2-hydroxy-2- methylpropanamide; | Bicalutamide – Impurity B |
PA 02 36030 | Deshydroxy Bicalutamide | Imp C | (RS)-N-[4-Cyano-3- (trifluoromethyl)phenyl]-3-[(4- fluorophenyl) sulfonyl]-2-methylpropanamide; |
25MG,50MG | NA | 906008-94-4 | 414.37 | C18H14F4N2O3S | N-[4-Cyano-3- trifluoromethyl)phenyl]-3-[(2- fluorophenyl)sulfonyl]-2-hydroxy-2- methylpropanamide; | Bicalutamide – Impurity C |
PA 02 36040 | 5-Amino-2-cyanobenzotrifluoride I | Imp D | 4-Amino-2-(trifluoromethyl)benzonitrile; 4- Amino-2-(trifluoromethyl)benzonitrile; 4- Amino-α,α,α-trifluoro-o-tolunitrile; | 25MG,50MG | NA | 654-70-6 | 186.13 | C8H5F3N2 | 2-Trifluoromethyl-4- aminobenzonitrile; 4-Cyano-3- (trifluoromethyl)aniline; | Bicalutamide – Impurity D |
PA 02 36050 | Bicalutamide Sulfoxide | Imp E | (N-[4-Cyano-3-(trifluoromethyl)phenyl]-3- [(4-fluorophenyl)sulfinyl]-2-hydroxy-2- methyl-propanamide); | 25MG,50MG | NA | 945419-64-7 | 414.37 | C18H14F4N2O3S | Bicalutamide Related Compound A; | Bicalutamide – Impurity E |
PA 02 36080 | N-(4-Cyano-3-(trifluoromethyl)phenyl)-2- ((4-fluorophenyl)sulfonyl)-3-hydroxy-2- methylpropanamide | Imp H | (2RS)-N-[4-Cyano-3- (trifluoromethyl)phenyl]-2-[(4- fluorophenyl)sulfonyl]-3-hydroxy-2- methylpropanamide; | 25MG,50MG | NA | NA | 430.37 | C18H14F4N2O4S | 3-hydroxy-2-methylpropanamide, N-(4-Cyano-3- (trifluoromethyl)phenyl)-2-((4- fluorophenyl)sulfonyl)-; | Bicalutamide – Impurity H |
PA 02 36100 | Bicalutamide Sulfide | Imp J | (+/-)-N-[4-Cyano-3- (trifluoromethyl)phenyl]-3-[(4- fluorophenyl)thio]-2-hydroxy-2-methylpropanamide; | 25MG,50MG | Refrigerator | 90356-78-8 | 398.37 | C18H14F4N2O2S | (R,S)-N-[4-Cyano-3- (trifluoromethyl)phenyl]-3-[(4- fluorophenyl)thio]-2-hydroxy-2- methylpropionamide | Bicalutamide – Impurity J |
PA 02 36510 | Bicalutamide S-Isomer | IH | (S)-Bicalutamide; (S)-Casodex; | 25MG,50MG | Freezer | 113299-38-0 | 430.37 | C18H14F4N2O4S | (2S)-N-[4-Cyano-3- (trifluoromethyl)phenyl]-3-[(4- fluorophenyl)sulfonyl]-2-hydroxy-2- methylpropanamide; | Bimatoprost – In house impurity |
PA 02 36520 | (R)-Bicalutamide | IH | (R)-Casodex; Bicalutamide R-Isomer; | 25MG,50MG | Freezer | 113299-40-4 | 430.37 | C18H14F4N2O4S | (2R)-N-[4-Cyano-3- (trifluoromethyl)phenyl]-3-[(4- fluorophenyl)sulfonyl]-2-hydroxy-2- methylpropanamide; | Bicalutamide – In house impurity |
PA 02 37000 | Bifonazole | API | (RS)-1-[phenyl(4-phenylphenyl)methyl]- 1H-imidazole; 1-(p,αDiphenylbenzyl)imidazole; | 25MG,50MG | NA | 60628-96-8 | 310.39 | C22H18N2 | NA | Bifonazole – API |
PA 02 37030 | 1H-Imidazole (Imidazole) | Imp C | 1,3-Diaza-2,4-cyclopentadiene; 1,3- Diazole; 3-Azapyrrole; 1H-Imidazole; |
25MG,50MG | Refrigerator | 288-32-4 | 68.08 | C3H4N2 | NA | Bifonazole – Impurity C |
PA 02 72000 | Bimatoprost | API | (5Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2- [(1E,3S)-3-hydroxy-5-phenyl-1-penten-1- yl]cyclopentyl]-N-ethyl-5-heptenamide; | 25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphere | 155206-00-1 | 415.57 | C25H37NO4 | AGN-192024; Lumigan; Prostamide; | Bimatoprost – API |
PA 02 72510 | Bimatoprost Acid | IH | (5Z)-7-[(1R,2R,3R,5S)-3,5- Dihydroxy-2-[(1E,3S)-3-hydroxy-5- phenyl-1-penten-1-yl]cyclopentyl]- 5-heptenoic Acid; 17-Phenyl18,19,20-trinor-PGF2α; PhXA 70; (5Z)-7-[(1R,2R,3R,5S)-3,5- dihydroxy-2-[(1E,3S)-3-hydroxy-5 | 25MG,50MG | Amber Vial, Freezer, Under Inert Atmosphere | 38344-08-0 | 388.5 | C23H32O5 | 17-Phenyl-18,19,20- trinorprostaglandin F2α; [1R- [1α(Z),2β(1E,3S*),3α,5α]]-7- [3,5-Dihydroxy-2-(3-hydroxy5-phenyl-1- pentenyl)cyclopentyl]-5- heptenoic Acid; | Bimatoprost – In house impurity |
PA 02 72520 | (5E)-Bimatoprost | IH | (5E)-7-[(1R,2R,3R,5S)-3,5- Dihydroxy-2-[(1E,3S)-3-hydroxy-5- phenyl-1-penten-1-yl]cyclopentyl]- N-ethyl-5-heptenamide; 5-transBimatoprost; 5,6-transBimatoprost; | 25MG,50MG | NA | 1163135-95-2 | 415.57 | C25H37NO4 | NA | Bimatoprost – In house impurity |
PA 02 72530 | (15R)-Bimatoprost | IH | (5Z)-7-[(1R,2R,3R,5S)-3,5- Dihydroxy-2-[(1E,3R)-3-hydroxy-5- phenyl-1-penten-1-yl]cyclopentyl]- N-ethyl-5-heptenamide; 15-epi Bimatoprost; | 25MG,50MG | NA | 1163135-92-9 | 415.57 | C25H37NO4 | NA | Bimatoprost – In house impurity |
PA 02 72540 | 15-Keto Bimatoprost | IH | (5Z)-7-[(1R,2R,3R,5S)-3,5- Dihydroxy-2-[(1E)-3-oxo-5-phenyl1-penten-1-yl]cyclopentyl]-N-ethyl5-heptenamide; Bimatoprost Impurity III; | 25MG,50MG | NA | 1163135-96-3 | 413.55 | C25H35NO4 | NA | Bimatoprost – In house impurity |
PA 02 72550 | (E)-7-((1R,2R,3R,5S)-3,5- Dihydroxy-2-((2R)-3-((S)-1-hydroxy3-phenylpropyl)oxiran-2- yl)cyclopentyl)-N-ethylhept-5- enamide; | IH | N-Ethylhept-5-enamide, (E)-7- ((1R,2R,3R,5S)-3,5-dihydroxy-2- ((2R)-3-((S)-1-hydroxy-3- phenylpropyl)oxiran-2- yl)cyclopentyl)-; |
25MG,50MG | NA | NA | 431.56 | C25H37NO5 | NA | Bimatoprost – In house impurity |
PA 02 75000 | Biotin | API | (3aS,4S,6aR)-Hexahydro-2-oxo-1Hthieno[3,4-d]imidazole-4-pentanoic Acid; (+)-Biotin; Vitamin B7; | 25MG,50MG | Refrigerator | 58-85-5 | 244.31 | C10H16N2O3S | Coenzyme R; D(+)-Biotin; Factor S; Lutavit H2; Meribin; NSC 63865; Rovimix H2; Vitamin H; Bios II; D-Biotin; | Bimatoprost – In house impurity |
PA 02 75010 | D-Biotin Dimer Acid | Imp A | (3aS,4S,6aR)-α-[3-[(3aS,4S,6aR)- Hexahydro-2-oxo-1H-thieno[3,4- d]imidazol-4-yl]propyl]hexahydro2-oxo-H-thieno[3,4-d]imidazole-4- pentanoic Acid; |
25MG,50MG | NA | 1163708-46-0 | 428.57 | C18H28N4O4S2 | Di[3-[(3aS,4S,6aR)-2- oxohexahydrothieno[3,4- d]imidazol-4-yl]propyl]acetic Acid; 5-((3aS,4S,6aR)-2- Oxohexahydro-1Hthieno[3,4-d]imidazol-4-yl)-2 | Biotin – API |
PA 02 75020 | Biotin Diacid | Imp B | 2-[3-[(3aS,4S,6aR)-Hexahydro-2-oxo-1Hthieno[3,4-d]imidazol-4- yl]propyl]propanedioic Acid; 4- [(3aS,4S,6aR)-2- Oxohexahydrothieno[3,4-d]imidazol-4- yl]butane-1,1-dicarboxylic Acid | 25MG,50MG | NA | 57671-79-1 | 288.32 | C11H16N2O5S | NA | Biotin – Impurity A |
PA 02 75030 | 5-(3,4-Diaminothiophen-2-yl)pentanoic Acid | Imp C | 3,4-Diamino-2-thiophenepentanoic Acid; 2-Thiophenepentanoic Acid, 3,4-diamino- ; Biotin Diamino Derivative | 25MG,50MG | NA | 412308-26-0 | 214.28 | C9H14N2O2S | NA | Biotin – Impurity B |
PA 02 75040 | 9-Methyl Biotin | Imp D | 2-Methyl-5-[(3aS,4S,6aR)-2- oxohexahydrothieno[3,4-d]imidazol-4- yl]pentanoic Acid; | 25MG,50MG | NA | 415725-35-8 | 258.34 | C11H18N2O3S | (3aS,4S,6aR)-Hexahydro-α-methyl2-oxo-1H-thieno[3,4-d]imidazole-4- pentanoic Acid; | Biotin – Impurity C |
PA 02 75050 | Mixture of 1’N-Benzyl Biotin and 3’N-Benzyl Biotin | Imp E | Mixture of N1-Benzyl Biotin and N3-Benzyl Biotin; 5- [(3aS,4S,6aR)-3-Benzyl-2- oxohexahydrothieno[3,4- d]imidazol-4-yl]pentanoic Acid and 5-[(3aS,4S,6aR)1-Benzyl-2- oxohexahydrothieno[3,4- d]imidazol-4-yl]pentanoic Acid; | 25MG,50MG | NA | 76335-62-1, 57229-92-2 | 666.87 | C34H44N4O6S2 | NA | Biotin – Impurity E |
25MG,50MG | ||||||||||
PA 02 75510 | Biotin Sulfoxide | IH | (-)-Biotin Sulfoxide; (3aS,4S,5R,6aR)- Hexahydro-2-oxo-1H-thieno[3,4- d]imidazole-4-pentanoic Acid 5-Oxide; | 25MG,50MG | NA | 3376-83-8 | 260.31 | C10H16N2O4S | [3aS-(3aα,4β,5β,6aα)]-Hexahydro2-oxo-1H-thieno[3,4-d]imidazole-4- pentanoic Acid 5-Oxide; Biotin 5- Oxide; (-)-Biotin 5-Oxide; Biotin, LS-oxide; Biotin l-sulfoxide; | Biotin – In house impurity |
PA 02 75520 | Biotin Sulfone | IH | (3aS,4S,6aR)-Hexahydro-2-oxo-1Hthieno[3,4-d]imidazole-4-pentanoic Acid 5,5-Dioxide; | 25MG,50MG | NA | 40720-05-6 | 276.31 | C10H16N2O5S | [3aS-(3aα,4β,6aα)]-Hexahydro-2- oxo-1H-thieno[3,4-d]imidazole-4- pentanoic Acid 5,5-Dioxide; Biotin 5,5-Dioxide; | Biotin – In house impurity |
PA 02 75530 | (+)-Biotin (+)-Sulfoxide | IH | (3aS,4S,5S,6aR)-Hexahydro-2- oxo-1H-Thieno[3,4-d]imidazole-4- pentanoic Acid 5-Oxide; [3aS- (3aα,4β,5α,6aα)]-Hexahydro-2- oxo-1H-Thieno[3,4-d]imidazole-4- pentanoic Acid 5-Oxide; (+)-Biotin 5-Oxide; Biotin D-S-oxide; Biotin (+)-Sulfoxide; Biotin d-Sulfoxide; | 25MG,50MG | Hygroscop ic, Refrigerat or, under inert atmospher e | 10406-89-0 | 260.31 | C10H16N2O4S | NA | Biotin – In house impurity |
PA 02 38000 | Bisacodyl | API | 4,4′-(2-Pyridinylmethylene)bisphenol 1,1′- Diacetate; 4,4′-(2- Pyridylmethylene)diphenol Diacetate; | 25MG,50MG | Refrigerator | 603-50-9 | 361.39 | C22H19NO4 | Bicol; Bis(p-acetoxyphenyl)-2- pyridylmethane; Brocalax; Broxalax; Dulcolax; Perilax; Stadalax; | Bisacodyl – API |
PA 02 38010 | Desdiacetyl Bisacodyl | Imp A | 4,4′-(2-Pyridinylmethylene)bisphenol; 4,4′- Dihydroxydiphenyl(2-pyridyl)methane; 4,4′-(Pyridin-2-ylmethylene)diphenol; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 603-41-8 | 277.32 | C18H15NO2 | Bis(4-hydroxyphenyl)(2- pyridyl)methane; DDPM; DDPM (pharmaceutical); Deacetylbisacodyl; La 96; Bisacodyl Related Compound A; | Bisacodyl – Impurity A |
PA 02 38020 | 2-((4-Hydroxyphenyl)(pyridin-2- yl)methyl)phenol | Imp B | 2,4′-(2-Pyridinyl-2methylene)diphenol; 2- [(4-Hydroxyphenyl)-2- pyridinylmethyl]phenol; | 25MG,50MG | NA | 16985-05-0 | 277.32 | C18H15NO2 | 2-[(RS)-(4-Hydroxyphenyl)(pyridin2-yl)methyl]phenol; Bisacodyl Related Compound B; | Bisacodyl – Impurity B |
PA 02 38030 | Desacetyl Bisacodyl | Imp C ‘ | 4-[[4-(Acetyloxy)phenyl]-2- pyridinylmethyl]phenol; 4-[(RS)-(4- Hydroxyphenyl)(pyridin-2- yl)methyl]phenyl Acetate; | 25MG,50MG | NA | 72901-16-7 | 319.35 | C20H17NO3 | 4-((4-Hydroxyphenyl)(pyridin-2- yl)methyl)phenyl Acetate; Bisacodyl Related Compound C; | Bisacodyl – Impurity C |
PA 02 38050 | 2-[(4-Acetoxyphenyl)(pyridin-2- yl)methyl]phenyl Acetate | Imp E | 4’-Desacetoxy-2’-Acetoxy Bisacodyl; 2- [[4-(Acetyloxy)phenyl]-2- pyridinylmethyl]phenol 1-Acetate; | 25MG,50MG | NA | 111664-35-8 | 361.39 | C22H19NO4 | 2,4’-(2-pyridylmethylene)diphenol Diacetate; Bisacodyl Related Compound E; | Bisacodyl – Impurity E |
PA 02 39000 | Bisoprolol | API | 1-{4-{[2-(1- Methylethoxy)ethoxy]methyl}phenoxy}-3- [(1-methylethyl)amino]-2-propanol; | 25MG,50MG | NA | 66722-44-9 | 325.44 | C18H31NO4 | 1-(4-((2- Isopropoxyethoxy)methyl)phenoxy)- 3-(isopropylamino)propan-2-ol; | Bisoprolol – API |
PA 02 40000 | Bisoprolol Fumarate | API | 1-[4-[[2-(1- Methylethoxy)ethoxy]methyl]phenoxy]-3- [(1-methylethyl)amino]-2-propanol; Bisoprolol Hemifumarate; | 25MG,50MG | Refrigerator | 104344-23-2 | 383.48 | 18H31NO4 •1/2[C4H4O4 | Concor; Detensiel; Emcor; Euradial; Isoten; Monocor; Soprol; Zebeta; | Bisoprolol Fumarate – API |
PA 02 40010 | Des(isopropoxyethyl) Bisoprolol | Imp A | 4-[2-Hydroxy-3-[(1- methylethyl)amino]propoxy]benzenemet hanol; H 119/68; | 25MG,50MG | Refrigerator | 62572-93-4 | 239.31 | C13H21NO3 | NA | Bisoprolol Fumarate – Impurity A |
PA 02 40020 | Isopropyl-{2-methyl-3-[4-(2- propoxy-ethoxymethyl)-phenoxy]- propyl}-amine | Imp B | (RS)-1-Isopropylamino-3-[4-(2- propoxyethoxymethyl)phenoxy]pr opan-2-ol; | 25MG,50MG | NA | NA | 325.44 | C18H31NO4 | N-Isopropyl-2-methyl-3-(4- ((2- propoxyethoxy)methyl)phen oxy)propan-1-amine; | Bisoprolol Fumarate – Impurity B |
PA 02 40030 | 1-{4-[4-(2-Hydroxy-3- isopropylamino-propoxy)-benzyl]- phenoxy}-3-isopropylaminopropan-2-ol | Imp C ‘ | (RS)-1-[4-[4-(2-Hydroxy-3- isopropylaminopropoxy)benzyl]ph enoxy]-3-isopropylaminopropan-2- ol; | 25MG,50MG | NA | NA | 430.58 | C25H38N2O4 | 3,3′-((Methylenebis(4,1- phenylene))bis(oxy))bis(1- (isopropylamino)propan-2- ol); | Bisoprolol Fumarate – Impurity C |
PA 02 40040 | (RS)-1-[4-[4-(2-Hydroxy-3- isopropylaminopropoxy)benzyloxyl methyl]phenoxy]-3- isopropylaminopropan-2-ol | Imp D | 3,3′-(((Oxybis(methylene))bis(4,1- phenylene))bis(oxy))bis(1- (isopropylamino)propan-2-ol); | 25MG,50MG | Refrigerator | 1225195-71- 0 | 460.61 | C26H40N205 | NA | Bisoprolol Fumarate – Impurity D |
PA 02 40050 | {3-[4-(2-Isopropoxy-ethoxymethyl)- phenoxy]-allyl}-isopropyl-amine | Imp E | Dehydro Bisoprolol; 3-[4-[[2-(1- Methylethoxy)ethoxy]methyl]phenoxy]-N- (1-methylethyl)-2-propen-1-amine; | 25MG,50MG | NA | 1217245-60-7 | 307.43 | C18H29NO3 | (E)-3-(4-((2- Isopropoxyethoxy)methyl)phenoxy)- N-isopropylprop-2-en-1-amine; (EZ)-[3-[4-(2-Isopropoxyethoxymethyl)phenoxy]allyl]isoprop | Bisoprolol Fumarate – Impurity E |
PA 02 40060 | 2-(4-((2- Isopropoxyethoxy)methyl)phenoxy )-3-(isopropylamino)propan-1-ol | Imp F | (2RS)-2-[4-(2-Isopropoxyethoxymethyl)phenoxy]-3- isopropylaminopropan-2-ol; | 25MG,50MG | NA | NA | 325.44 | C18H31NO4 | NA | Bisoprolol Fumarate – Impurity F |
PA 02 40070 | (2RS)-1-[4-(((2-Isopropoxyethoxy)methoxy)methyl)phenoxy]-3- (isopropyl-amino)-2-propanol | Imp G | rac Des(isopropoxyethyl)-2- isopropoxyethoxymethyl Bisoprolol; 1-(4- (((2- Isopropoxyethoxy)methoxy)methyl)phen oxy)-3-(isopropylamino)propan-2-ol; | 25MG,50MG | NA | 1215342-36-1 | 355.47 | C19H33NO5 | 1-[4-[[(2- Isopropoxyethoxy)methoxy]methyl] phenoxy]-3-isopropylamino-2- propanol; | Bisoprolol Fumarate – Impurity G |
PA 02 40100 | (2RS)-3-[4-((2- Isopropoxyethoxy)methyl)phenoxy]-1,2- propanediol | Imp J | 3-(4-((2- Isopropoxyethoxy)methyl)phenoxy)propa ne-1,2-diol; 3-[4-[(2- Isopropoxyethoxy)methyl]phenoxy]-1,2- propanediol; | 25MG,50MG | NA | 1797024-50-0 | 284.35 | C15H24O5 | NA | Bisoprolol Fumarate – Impurity J |
PA 02 40110 | 4-(2-Hydroxy-3-isopropylamino-propoxy)- benzoic acid 2-isopropoxy-ethyl Ester | Imp K | Keto Bisoprolol; 4-[2-Hydroxy-3-[(1- methylethyl)amino]propoxy]-benzoic acid 2-(1-methylethoxy)ethyl Ester; 2- Isopropoxyethyl 4-(2-hydroxy-3- (isopropylamino)propoxy)benzoate; | 25MG,50MG | NA | 864544-37-6 | 339.43 | C18H29NO5 | 2-Isopropoxyethyl-4-[[(2RS)-2- hydroxy-3- (isopropylamino)propyl]oxy]benzoa te; Bisoprolol Ester Impurity; | Bisoprolol Fumarate – Impurity K |
PA 02 40120 | 4-[((2RS)-2-Hydroxy-3-(isopropylamino)- propyl)oxy]benzaldehyde Hydrochloride | Imp L | 4-[(2RS)-2-Hydroxy-3-[(1- methylethyl)amino]propoxy]benzaldehyd e Hydrochloride; | 25MG,50MG | NA | 29122-74-5 | 273.76 | C13H20ClNO3 | 4-(2-Hydroxy-3- (isopropylamino)propoxy)benzalde hyde Hydrochloride; | Bisoprolol Fumarate – Impurity L |
PA 02 40130 | 4-[(2-Isopropoxyethoxy)methyl]phenol | Imp M | 4-((2-Isopropoxyethoxy)methyl)phenol; 4- [[2-(1- Methylethoxy)ethoxy]methyl]phenol; | 25MG,50MG | Refrigerator | 177034-57-0 | 210.27 | C12H18O3 | NA | Bisoprolol Fumarate – Impurity M |
PA 02 40140 | (2RS)-1-[4-((2- Ethoxyethoxy)methyl)phenoxy]-3- (isopropylamino)-2-propanol | Imp N | [(2RS)-1-[4-[(2- Ethoxyethoxy)methyl]phenoxy]-3- isopropylaminopropan-2-ol; 1-(4-((2- Ethoxyethoxy)methyl)phenoxy)-3- (isopropylamino)propan-2-ol; | 25MG,50MG | NA | 1346601-75-9 | 311.42 | C17H29NO4 | NA | Bisoprolol Fumarate – Impurity N |
PA 02 40170 | (2RS)-1-Isopropylamino-3-[4-(2- methoxyethoxy)methyl]-phenoxy-2- propanol | Imp Q | (2RS)-1-(Isopropylamino)-3-[4-(2- methoxyethoxy)methylphenoxy]propan-2- ol; 1-(Isopropylamino)-3-(4-((2- methoxyethoxy)methyl)phenoxy)propan2-ol; | 25MG,50MG | NA | 1346604-00-9 | 297.39 | C16H27NO4 | NA | Bisoprolol Fumarate – Impurity Q |
PA 02 40180 | (2RS)-1-(Isopropylamino)-3-(4- methylphenoxy)propan-2-ol | Imp R | 1-(Isopropylamino)-3-(p-tolyloxy)propan2-ol; | 25MG,50MG | NA | 5790-46-5 | 223.31 | C13H21NO2 | NA | Bisoprolol Fumarate – Impurity R |
PA 02 40190 | 4-Hydroxybenzaldehyde | Imp S | p-hydroxybenzaldehyde; 4- Formylphenol; NSC 2127 | 25MG,50MG | Refrigerator | 123-08-0 | 122.12 | C7H6O2 | Parahydroxybenzaldehyde; pFormylphenol; pHydroxybenzaldehyde; pOxybenzaldehyde | Bisoprolol Fumarate – Impurity S |
PA 02 40200 | 4-((3-Isopropyl-2-oxooxazolidin-5- yl)methoxy)benzaldehyde | Imp T | 4-[(3-Isopropyl-2-oxo-1,3- oxazolidin-5- yl)methoxy]benzaldehyde; 4-[[3- (1-Methylethyl)-2-oxo-5- oxazolidinyl]methoxy]benzaldehy de; | 25MG,50MG | NA | 1173203-26-3 | 263.29 | C14H17NO4 | NA | Bisoprolol Fumarate – Impurity T |
PA 02 40210 | 5-[[4- (Hydroxymethyl)phenoxy]methyl]-3- isopropyl-1,3-oxazolidin-2-one | Imp U | 5-((4- (Hydroxymethyl)phenoxy)methyl)- 3-isopropyloxazolidin-2-one; | 25MG,50MG | NA | 1071765-44-0 | 265.3 | C14H19NO4 | NA | Bisoprolol Fumarate – Impurity U |
PA 02 40510 | 4-Hydroxybenzyl Alcohol | IH | 4-Hydroxybenzenemethanol; pHydroxybenzyl Alcohol; (4- Hydroxyphenyl)methanol; 4- (Hydroxymethyl)phenol; 4- Hydroxybenzenemethanol; 4- Hydroxybenzyl Alcohol; 4- Methylolphenol; | 25MG,50MG | Refrigerator | 623-05-2 | 124.17 | C7H8O2 | Gastrodigenin; NSC 227926; p- (Hydroxymethyl)phenol; p-2- Hydroxybenzyl Alcohol; pHydroxybenzenemethanol; pHydroxybenzyl Alcohol; pMethoxytoluol; p-Methylolphenol; αHydroxy-p-cresol | Bisoprolol Fumarate – In house impurity |
PA 02 40520 | Fumaric Acid | IH | (2E)-2-Butenedioic Acid; (2E)-But-2- enedioic Acid; (E)-2-Butenedioic Acid; trans-1,2-Ethylenedicarboxylic Acid; trans-2-Butenedioic Acid; trans | 25MG,50MG | Refrigerator | 110-17-8 | 116.07 | C4H4O4 | 2-(E)-Butenedioic Acid; (E)- Butenedioic Acid; Allomaleic Acid; Bakeshure 451; Bakeshure 470; Boletic Acid; FC 33; Lichenic Acid; | Bisoprolol Fumarate – In house impurity |
PA 02 40530 | 4-(2-Hydroxy-3- isopropylaminopropoxy)benzoic Acid | IH | Bisoprolol Carboxylic Acid Impurity; 4-[2- Hydroxy-3-[(1- methylethyl)amino]propoxy]benzoic Acid; H 112/02; Bisoprolol Acid Impurity | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 72570-70-8 | 253.29 | C13H19NO4 | NA | Bisoprolol Fumarate – In house impurity |
PA 02 41000 | Bisphenol A Diglycidyl Ether | API | 4,4′-(1-Methylethylidene)bisphenol Diglycidyl Ether; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 1675-54-3 | 340.41 | C21H24O4 | 2,2-Bis(4-hydroxyphenyl)propane Diglycidyl Ether; BADGE; | Bisphenol A Diglycidyl Ether – API |
PA 02 41510 | 4’-O-Benzyl Bisphenol A β-D-Glucuronide | IH | 4-[1-(4-Benzyloxyphenyl)-1- methylethyl]phenyl β-DGlucopyranosiduronic Acid; | 25MG,50MG | NA | NA | 494.53 | C28H30O8 | NA | Bisphenol – In house impurity |
PA 02 41520 | 4’-O-Benzyl Bisphenol A β-D-Glucuronic Acid Methyl Ester | IH | 4-[1-(4-Benzyloxyphenyl)-1- methylethyl]phenyl β-DGlucopyranosiduronic Acid Methyl Ester; | 25MG,50MG | NA | NA | 508.56 | C29H32O8 | NA | Bisphenol – In house impurity |
PA 02 41530 | 4’-O-Benzyl Bisphenol A Tri-O-acetyl-β-Dglucuronic Acid Methyl Ester | IH | 4-[1-(4-Benzyloxyphenyl)-1- methylethyl]phenyl Tri-O-acetyl-β-Dglucopyranosiduronic Acid Methyl Ester; | 25MG,50MG | NA | NA | 634.67 | C35H38O11 | NA | Bisphenol – In house impurity |
PA 02 41540 | 4,4′-(1,3,3-Trimethyl-1-propene1,3-diyl)bisphenol | IH | 4,4′-(1,3,3-Trimethyl-1-propene1,3-diyl)bisphenol; | 25MG,50MG | NA | 57244-54-9 | 268.35 | C18H20O2 | NA | Bisphenol – In house impurity |
PA 02 41550 | Bisphenol A 4-O-4’-O-Di(tri-O-benzoyl-βD-glucuronic Acid Methyl Ester) | IH | Bisphenol A 4-O-4’-O-Di(tri-O-benzoyl-βD-glucuronic Acid Methyl Ester); | 25MG,50MG | Refrigerator | NA | 1233.22 | C71H60O20 | NA | Bisphenol – In house impurity |
PA 02 41560 | Bisphenol A β-D-Glucuronide | IH | 4-[1-(4-Hydroxyphenyl)-1- methylethyl]phenyl β-DGlucopyranosiduronic Acid; | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 267244-08-6 | 404.41 | C21H24O8 | NA | Bisphenol – In house impurity |
PA 02 41570 | Bisphenol A Bissulfate Disodium Salt | IH | 4,4′-(1-Methylethylidene)bisphenol Bis(Hydrogen Sulfate) Disodium Salt | 25MG,50MG | Refrigerator | 10040-44-5 | 432.38 | C15H14Na2O8S2 | 4,4′-Isopropylidenediphenol Bis(Hydrogen Sulfate) Disodium Salt; | Bisphenol – In house impurity |
PA 02 41580 | Bisphenol A Bis-(β-D-glucuronide) | IH | 4,4′-(1-Methylethylidene)bisphenol Bisglucuronide; | 25MG,50MG | NA | NA | 580.53 | C27H32O14 | NA | Bisphenol – In house impurity |
PA 02 41590 | Bisphenol A Bis(2,3-dihydroxypropyl) Ether | IH | 3,3′-[(1-Methylethylidene)bis(4,1- phenyleneoxy)]bis-1,2-propanediol; | 25MG,50MG | NA | 5581-32-8 | 376.44 | C21H28O6 | 3,3′-[Isopropylidenebis(pphenyleneoxy)]di-1,2-propanediol; 2,2-Bis[4-(2,3- dihydroxypropoxy)phenyl]propane; BADGE.2H2O; BADGETOL; | Bisphenol – In house impurity |
PA 02 41600 | Bisphenol A Bis(diphenyl phosphate) | IH | Phosphoric Acid, (1-Methylethylidene)di4,1-phenylene Tetraphenyl Ester; Phosphoric Acid Isopropylidenedi-pphenylene Tetraphenyl Ester; 4,4′- (Isopropylidenediphenyl) bis(diphenyl phosphate); | 25MG,50MG | Refrigerator | 5945-33-5 | 692.63 | C39H34O8P2 | 2,2-Bis[4- [bis(phenoxy)phosphoryloxy]pheny l]propane; ADK Stab FP 600; ADK Stab FP 700; BADP; BDP; BPADP; Bisphenol A tetraphenyl diphosphate; CG 963; CR 741S; CR 742; E 890; FP 600; FP 700; FP 750; Fyrolflex BDP; NcendX P 30; Ncendex P 30; Tetrapheny | Bisphenol – In house impurity |
PA 02 41610 | Bisphenol A Monobenzyl Ether | IH | 4-[1-Methyl-1-[4- (phenylmethoxy)phenyl]ethyl]phenol | 25MG,50MG | NA | 42781-88-4 | 318.41 | C22H22O2 | NA | Bisphenol – In house impurity |
PA 02 41620 | Bisphenol A Bissulfate Diammonium Salt | IH | 4,4′-(1-Methylethylidene)bis-Phenol Bis(hydrogen sulfate) Diammonium Salt; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 857283-05-7 | 422.47 | C15H22N2O8S2 | NA | Bisphenol – In house impurity |
PA 02 41630 | 3-Chlorobisphenol A | IH | 2-Chloro-4-[1-(4-hydroxyphenyl)-1- methylethyl]phenol; | 25MG,50MG | Amber Vial, Refrigerator | 74192-35-1 | 262.73 | C15H15ClO2 | 2-Chloro-4,4′- isopropylidenediphenol; Chlorobisphenol A; | Bisphenol – In house impurity |
PA 02 41640 | 3,3′-Dichlorobisphenol A | IH | 4,4′-(1-Methylethylidene)bis[2- chlorophenol]; 2,2-Bis(3-chloro-4- hydroxyphenyl) propane; | 25MG,50MG | Room Temp | 79-98-1 | 297.18 | C15H14Cl2O2 | 2,2-Di(4-hydroxy-3- chlorophenyl)propane; 2,2′- Dichlorobisphenol A; 3,3′- Dichlorodian; NSC 18247 | Bisphenol – In house impurity |
PA 02 41650 | 3,5,3′,5′-Tetrachlorobisphenol A | IH | 4,4′-(1-Methylethylidene)bis[2,6- dichlorophenol; 2,2-Bis(3,5-dichloro-4- hydroxyphenyl) propane; | 25MG,50MG | Refrigerator | 79-95-8 | 366.07 | C15H12Cl4O2 | 2,2-Bis(4-hydroxy-3,5- dichlorophenyl)propane; Tetrachlorodian; Tetrachlorobisphenol A; NSC 18248; NSC 67465; | Bisphenol – In house impurity |
PA 02 41660 | Tetramethyl Bisphenol A | IH | 2,2-Bis(3,5-dimethyl-4- hydroxyphenyl)propane; Bisxylenol A; 4,4′-Isopropylidenedi-2,6-xylenol; | 25MG,50MG | NA | 5613-46-7 | 284.39 | C19H24O2 | NSC 73730; 2,2-Bis(4-hydroxy-3,5- dimethylphenyl)propane; Tetramethylbisphenol A; 3,3′,5,5′- Tetramethyl-4,4′-dihydroxydiphenyl2,2-propane; 4,4′- Isopropylidenebis(2,6- dimethylphenol); | Bisphenol – In house impurity |
PA 02 41670 | 3,3′,5-Trichlorobisphenol A | IH | 2,6-Dichloro-4-[1-(3-chloro-4- hydroxyphenyl)-1-methylethyl]phenol; Trichlorobisphenol A; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 40346-55-2 | 331.62 | C15H13Cl3O2 | NA | Bisphenol – In house impurity |
PA 02 42000 | Boceprevir | API | (1R,2S,5S)-N-[3-Amino-1- (cyclobutylmethyl)-2,3-dioxopropyl]-3- [(2S)-2-[[[(1,1- dimethylethyl)amino]carbonyl]amino]-3,3- dimethyl-1-oxobutyl]-6,6-dimethyl-3- azabicyclo[3.1.0]hexane-2-carboxamide; | 25MG,50MG | Refrigerator | 394730-60-0 | 519.68 | C27H45N5O5 | EBP 520; Sch 503034; | Boceprevir – API |
PA 02 42510 | β-Amino-αhydroxycyclobutanebutanamide Hydrochloride | IH | 3-amino-4-cyclobutyl-2- hydroxybutanamide Hydrochloride; | 25MG,50MG | Refrigerator | 394735-23-0 | 208.69 | C8H17ClN2O2 | NA | Boceprevir – In house impurity |
PA 02 42520 | Boceprevir Metabolite M4 | IH | (1R,2S,5S)-3-[(2S)-2-[[[[1,1- Dimethylethyl]amino]carbonyl]amino]-3,3- dimethyl-1-oxobutyl]-6,6-dimethyl-3- azabicyclo[3.1.0]hexane-2-carboxylic Acid; | 25MG,50MG | NA | 816444-90-3 | 367.48 | C19H33N3O4 | NA | Boceprevir – In house impurity |
PA 02 42530 | Boceprevir Metabolite M15 | IH | (1R,2S,5S)-3-[(2S)-2-[[[[1,1- Dimethylethyl]amino]carbonyl]amino]-3,3- dimethyl-1-oxobutyl]-6,6-dimethyl-3- azabicyclo[3.1.0]hexane-2-carbamide; | 25MG,50MG | NA | 1351791-45-1 | 366.5 | C19H34N4O3 | NA | Boceprevir – In house impurity |
PA 02 42540 | 2’-Dihydro Boceprevir (Boceprevir Metabolite M28+M31 (Mixture of Diastereomers)) | IH | (1R,2S,5S)-N-[3-amino-1- (cyclobutylmethyl)-2-hydroxy-3- oxopropyl]-3-[(2S)-2-[[[(1,1- dimethylethyl)amino]carbonyl]ami no]-3,3-dimethyl-1-oxobutyl]-6,6- dimethyl-3- azabicyclo[3.1.0]hexane-2 | 25MG,50MG | Refrigerator | NA | 521.69 | C27H47N5O5 | (1’S,2’R)-2’-Dihydro Boceprevir (Boceprevir Metabolite M28); |
Boceprevir – In house impurity |
PA 02 42550 | (3R,7aS)-1,7a-Dihydro-3-phenyl-3H,5Hpyrrolo[1,2-c]oxazol-5-one | IH | (3R,7aS)-1,7a-Dihydro-3-phenyl-3H,5Hpyrrolo[1,2-c]oxazol-5-one; | 25MG,50MG | NA | 134107-65-6 | 201.22 | C12H11NO2 | (3R,7aS)-3-Phenyl-1,7a-dihydro5H-pyrrolo[1,2-c][1,3]oxazol-5-one | Boceprevir – In house impurity |
PA 02 42560 | (3R,7aS)-Tetrahydro-3-phenyl-3H,5Hpyrrolo[1,2-c]oxazol-5-one | IH | (+)-(3R,7aS)-Tetrahydro-3-phenyl-3H,5Hpyrrolo[1,2-c]oxazol-5-one; | 25MG,50MG | NA | 103201-79-2 | 203.24 | C12H13NO2 | NA | Boceprevir – In house impurity |
PA 02 43000 | Boldenone | API | 17beta-Hydroxyandrosta-1,4-dien-3-one; (8R,9S,10R,13S,14S,17S)-17-Hydroxy10,13-dimethyl6,7,8,9,10,11,12,13,14,15,16,17- dodecahydro-3Hcyclopenta[a]phenanthren-3-one; 1- Dehydrotestosterone; | 25MG,50MG | NA | 846-48-0 | 286.41 | C19H26O2 | Testosterone Imp H; | Bortezomib – API |
PA 02 79000 | Bortezomib | API | (1R,2S)-Bortezomib; [(1R)-3-Methyl-1- [[(2S)-1-oxo-3-phenyl-2- [(pyrazinylcarbonyl)amino]propyl]amino]b utyl]boronic Acid; Velcade; Radiciol; NSC 681239; DPBA; LDP 341; | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 179324-69-7 | 384.24 | C19H25BN4O4 | B-[(1R)-3-Methyl-1-[[(2S)-1-oxo-3- phenyl-2-[(2- pyrazinylcarbonyl)amino]propyl]am ino]butyl]boronic Acid; MG 341; MLN 341; NSC 681239; PS 314; PS 341; Radiciol; Velcade; | Bortezomib – API |
PA 02 79010 | Bortezomib Amide Impurity | Imp A | (2S)-3-Phenyl-2-[(pyrazin-2- ylcarbonyl)amino]propanamide; N-[(1S)- 2-Amino-2-oxo-1-(phenylmethyl)ethyl]-2- pyrazinecarboxamide; | 25MG,50MG | NA | 289472-80-6 | 270.29 | C14H14N4O2 | N-[(1S)-2-amino-2-oxo-1- (phenylmethyl)ethyl]pyrazinecarbo xamide; Pyrazine-2-carboxylic acid (1-carbamoyl-2-phenyl-ethyl)- amide; | Bortezomib – Impurity A |
PA 02 79020 | Bortezomib Acid Impurity | Imp B | (2S)-3-Phenyl-2-[(pyrazin-2- ylcarbonyl)amino]propanoic Acid; NPyrazinylcarbonyl-L-phenylalanine; | 25MG,50MG | Refrigerator | 114457-94-2 | 271.27 | C14H13N3O3 | N-(2-pyrazinylcarbonyl)-Lphenylalanine; 3-Phenyl-2- [(pyrazine-2- carbonyl)amino]propionic Acid; | Bortezomib – Impurity B |
PA 02 79030 | Bortezomib N-Pentyl Impurity | Imp C | Desisobutyl-n-butyl Bortezomib; B-[(1R)- 1-[[(2S)-1-Oxo-3-phenyl-2-[(2- pyrazinylcarbonyl)amino]propyl]amino]pe ntyl]boronic Acid; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 1104011-35-9 | 384.24 | C19H25BN4O4 | 1-[[(2S)-1-Oxo-3-phenyl-2- [(pyrazinylcarbonyl) amino]propyl]amino] pentylboronic Acid; | Bortezomib – Impurity C |
PA 02 79040 | Bortezomib (1R,2R)-Isomer | Imp D | (1R,2R)-Bortezomib; [(1R)-3-Methyl-1- ({(2R)-3-phenyl-2-[(pyrazin-2- ylcarbonyl)amino]propanoyl} amino)butyl]boronic Acid; Bortezomib R,R-Isomer; | 25MG,50MG | NA | 1132709-15-9 | 384.24 | C19H25BN4O4 | B-[(1R)-3-Methyl-1-[[(2R)-1-oxo-3- phenyl-2-[(2- pyrazinylcarbonyl)amino]propyl]am ino]butyl]boronic Acid; [(1R)-3- Methyl-1-[[(2R)-1-oxo-3-phenyl-2- [(pyrazinylcarbonyl)amino]propyl]a mino]butyl]boronic Acid; | Bortezomib – Impurity D |
PA 02 79041 | Bortezomib (1S,2S)-Isomer | Imp D | [(1S)-3-Methyl-1-({(2S)-3-phenyl-2- [(pyrazin-2-ylcarbonyl)amino]propanoyl} amino)butyl]boronic Acid; | 25MG,50MG | Hygroscopic, Freezer, Under inert atmosphere | 1132709-14-8 | 384.24 | C19H25BN4O4 | (1S,2S)-Bortezomib; B-[(1S)-3- methyl-1-[[(2S)-1-oxo-3-phenyl-2- [(2- pyrazinylcarbonyl)amino]propyl]am ino]butyl]-boronic Acid; | Bortezomib – Impurity D |
PA 02 79050 | Bortezomib Hydroxy Impurity (1R,2S)- Isomer | Imp E | N-[(2S)-1-{[(1R)-1-Hydroxy-3-methyl butyl]amino}-1-oxo-3-phenylpropan-2yl]pyrazine-2-carboxamide; (R)-Hydroxy Des(boric Acid) Bortezomib; N-[(1S)-2[[(1R)-1-Hydroxy-3-methylbutyl]amino]-2oxo-1-(phenylmethyl)ethyl]-2pyrazinecarboxamide | 25MG,50MG | NA | 289472-78-2 | 356.42 | C19H24N4O3 | N-[(1S)-2-[[(1R)-1-hydroxy-3- methylbutyl]amino]-2-oxo-1- (phenylmethyl)ethyl]pyrazinecarbo xamide; Pyrazine-2-carboxylic acid [1-(1-hydroxy-3-methylbutylcarbamoyl)-2-phenyl-ethyl]- amide; | Bortezomib – Impurity E |
PA 02 79060 | Bortezomib Acid Methyl Ester | Imp F | (2S)-3-Phenyl-2-[(pyrazin-2- ylcarbonyl)amino]propanoic Acid Methyl Ester; N-Pyrazinylcarbonyl-Lphenylalanine Methyl Ester; | 25MG,50MG | NA | 73058-37-4 | 285.3 | C15H15N3O3 | N-(2-Pyrazinylcarbonyl)-Lphenylalanine Methyl Ester; 3- Phenyl-2-[(pyrazine-2- carbonyl)amino]propionic Acid Methyl Ester; | Bortezomib – Impurity F |
PA 02 79070 | Bortezomib Hydroxy Impurity (1S,2S)- Isomer | Imp G | N-[(2S)-1-{[(1S)-1-Hydroxy-3-methyl butyl]amino}-1-oxo-3-phenylpropan-2- yl]pyrazine-2-carboxamide; (S)-Hydroxy Des(boric Acid) Bortezomib; | 25MG,50MG | Freezer | 289472-81-7 | 356.42 | C19H24N4O3 | N-[(1S)-2-[[(1S)-1-hydroxy-3- methylbutyl]amino]-2-oxo-1- (phenylmethyl)ethyl]-2- Pyrazinecarboxamide; N-[(1S)-2- [[(1S)-1-hydroxy-3- methylbutyl]amino]-2-oxo-1- (phenylmethyl)ethyl]- pyrazinecarboxamide; | Bortezomib – Impurity G |
PA 02 79510 | 1-Bromo-2-methylpropane | IH | 1-Methyl-2-propyl Bromide; 2- Methylpropyl Bromide; Bromoisobutane; | 25MG,50MG | NA | 78-77-3 | 137.02 | C4H9Br | Isobutyl Bromide; NSC 8416; iso-Butyl Bromide; | Bortezomib – In house impurity |
PA 02 79520 | (1S)-(1S,2S,3R,5S)-Pinanediol-1- ammoniumtrifluoroacetate-3- methylbutane-1-boronate | IH | (S)-BoroLeu-(-)-PinanediolCF3COOH; | 25MG,50MG | NA | 477254-69-6 | 379.22 | C17H29BF3NO4 | NA | Bortezomib – In house impurity |
PA 02 79530 | Bortezomib (1S,2R)-Isomer | IH | (1S,2R)-Bortezomib; [(1S)-3- Methyl-1-({(2R)-3-phenyl-2- [(pyrazin-2- ylcarbonyl)amino]propanoyl} amino)butyl]boronic Acid; | 25MG,50MG | NA | 1132709-16-0 | 384.24 | C19H25BN4O4 | B-[(1S)-3-Methyl-1-[[(2R)-1- oxo-3-phenyl-2-[(2- pyrazinylcarbonyl)amino]pro pyl]amino]butyl]boronic Acid; | Bortezomib – In house impurity |
PA 02 79540 | N-(1-(((R)-1-Hydroxy-3- methylbutyl)amino)-1-oxo-3- phenylpropan-2-yl)pyrazine-2- carboxamide |
IH | Bortezomib Impurity 2 (Mixture of (1S,2R)-Isomer and (1R,2R)Isomer | 25MG,50MG | NA | NA | 356.42 | C19H24N4O3 | NA | Bortezomib – In house impurity |
PA 29 01000 | Boscalid | API | 2-Chloro-N-(4’-chloro[1,1’biphenyl]-2-yl)-3pyridinecarboxamide; 2-Chloro-N(4’-chlorobiphenyl-2yl)nicotinamide | 25MG,50MG | Refrigerat or | 188425-85-6 | 343.21 | C18H12Cl2N2O | NA | Boscalid – API |
PA 02 21000 | Bosentan Hydrate | API | Bosentan Monohydrate; 4-(1,1Dimethylethyl)-N-[6-(2hydroxyethoxy)-5-(2methoxyphenoxy)[2,2′bipyrimidin]-4yl]benzenesulfonamide monohydrate; | 25MG,50MG | Freezer | 157212-55-0 | 569.63 | C27H31N5075 | 4-Tert-butyl-N-[6-(2hydroxyethoxy)-5-(2methoxy-phenoxy)-[2,2´]bipyrimidin-4-yl]benzenesulfonamide monohydrate, Ro-47-0203; 4-(1,1-Dimethylethyl)-N-[6-(2hydroxyethoxy)-5-(2methoxyphenoxy | Bosentan Hydrat e – API |
PA 02 21510 | 4-(tert-Butyl)benzenesulfonamide | IH | 4-tert-Butylbenzenesulfonamide; 4-(1,1Dimethylethyl)benzenesulfonami de; p-tert-butylBenzenesulfonamide | 25MG,50MG | NA | 6292-59-7 | 213.3 | C10H15NO2S | p-(tertButyl)phenylsulfonamide; ptertButylbenzenesulfonamide; NSC 9911; | Bosentan Hydrate – In house impurity |
PA 02 21520 | 4-(tert-Butyl)benzene-1-sulfonyl chloride |
IH | 4-tert-Butylbenzenesulfonyl Chloride; 4-tert-Butylbenzenesulfonyl Chloride | 25MG,50MG | NA | 15084-51-2 | 232.73 | C10H13ClO2S | NA | Bosentan Hydrate – In house impurity |
PA 02 21530 | 4-(tert-Butyl)-N-[6-chloro-5-(2- methoxyphenoxy)-(2,2′- bipyrimidin)-4-yl] benzenesulfonamide | IH | N-[6-Chloro-5-(2methoxyphenoxy)-(2,2bipyrimidine)4-4-yl]-(1,1dimethylethyl)benzenesulfonamide; 4-tert-ButylN-[6-chloro-5-(2methoxyphenoxy)-2-(2pyrimidinyl | 25MG,50MG | Freezer | 150727-3 | 526.01 | C25H24ClN5O4S | Bosentan Related Compound A; | Bosentan Hydrate – In house impurity |
PA 02 21540 | 4-(tert-Butyl)-N-[6-hydroxy-5-(2- methoxyphenoxy)-(2,2′- bipyrimidin)-4- yl]benzenesulfonamide | IH | O-Deshydroxyethyl Bosentan; N[1,6-Dihydro-5-(2methoxyphenoxy)-6-oxo[2,2’bipyrimidin]-4-yl]-4-(1,1dimethylethyl)benzenesulfonamid e; 4-tert-Butyl-N-[6-hydroxy-5-(2methoxyphenoxy)-2,2’-bipyrimidin4 | 25MG,50MG | NA | 174227-14-6 | 507.56 | C25H25N5O5S | Bosentan Related Compound B; | Bosentan Hydrate – In house impurity |
PA 02 21550 | 6-Chloro-5-(2-methoxyphenoxy)- [2,2′-bipyrimidin]-4(3H)-one | IH | [2,2′-Bipyrimidin]-4(3H)-one, 6chloro-5-(2-methoxyphenoxy)-; | 25MG,50MG | NA | NA | 330.73 | C15H11ClN4O3 | NA | Bosentan Hydrate – In house impurity |
PA 02 92000 | Bosutinib | API | 4-[(2,4-Dichloro-5methoxyphenyl)amino]-6methoxy-7-[3-(4-methyl-1piperazinyl)propoxy]-3quinolinecarbonitrile; | 25MG,50MG | Refrigerat or | 380843-75-4 | 530.45 | C26H29Cl2N5O3 | NA | Bosutinib – API |
PA 02 77000 | Bosutinib Monohydrate | API | 4-[(2,4-Dichloro-5methoxyphenyl)amino]-6methoxy-7-[3-(4-methyl-1piperazinyl)propoxy]-3quinolinecarbonitrile Monohydrate; SKI-606; WAY173606; | 25MG,50MG | Refrigerat or | 918639-08-4 | 548.46 | C26H31Cl2N5O4 | 4-[(2,4-dichloro-5- methoxyphenyl)amino]-6- methoxy-7-[3-(4- methylpiperazin-1- yl)propoxy]quinoline-3- carbonitrile Monohydrate; | Bosutinib Monohydrate – API |
PA 02 86000 | Bretylium Tosylate | API | 2-Bromo-N-ethyl-N,Ndimethylbenzenemethanaminium 4Methylbenzenesulfonate; (oBromobenzyl)ethyldimethylammonium pToluenesulfonate; (oBromobenzyl)ethyldimethylammonium pToluenesulfonate; | 25MG,50MG | Refrigerat | 61-75-6 | 414.36 | C18H24BrNO3S | ASL 603; Bretylan; Bretylate; Bretylium p-Toluenesulfonate; Bretylium Tosilate; Bretylol; Darenthin; N-Ethyl-N-(obromobenzyl)-N,Ndimethylammonium Tosylate; NSC 62164; Ornid; | Bretylium Tosylate – API |
PA 02 96000 | Brexpiprazole | API | 7-[4-(4-(Benzo[b]thien-4-yl)piperazin-1-yl)butoxy]-1H-quinolin2-one; | 25MG,50MG | Refrigerat or | 913611-97-9 | 433.57 | C25H27N3O2S | NA | Brexpiprazole – API |
PA 02 96510 | 7-(4-(4-(1-Oxidobenzo[b]thiophen4-yl)piperazin-1-yl)butoxy)quinolin2(1H)-one’ | IH | 2(1H)-Quinolinone, 7-(4-(4-(1oxidobenzo(b)thien-4-yl)-1piperazinyl)butoxy)-; DM-3411 | 25MG,50MG | NA | 1191900-512 | 449.57 | C25H27N3O3S | NA | Brexpiprazole – In house Impurity |
PA 02 96520 | 1,4-Bis(benzo[b]thiophen-4- yl)piperazine | IH | Brexpiprazole Impurity 1 | 25MG,50MG | NA | 1420987-86-5 | 350.5 | C20H18N2S2 | NA | Brexpiprazole – In house Impurity |
PA 02 44000 | Brimonidine | API | 5-Bromo-N-(4,5-dihydro-1H-imidazol-2yl)-6-quinoxalinamine; | 25MG,50MG | Refrigerator | 59803-98-4 | 292.13 | C11H10BrN5 | 5-Bromo-6-(2-imidazolin-2- ylamino)quinoxaline; Bromoxidine; AGN-190342; UK-14304; | Brimonidine – API |
PA 02 44010 | N-(4,5-Dihydro-1H-imidazol-2-yl)-6- quinoxalinamine | IMPA | N-(4,5-Dihydro-1H-imidazol-2yl)quinoxalin-6-amine; | 25MG,50MG | NA | 91147-43-2 | 213.24 | C11H11N5 | NA | Brimonidine – Impurity A |
PA 02 44020 | 5-Bromoquinoxalin-6-amine | IMPB | 6-Amino-5-bromoquinoxaline; 5-Bromo-6quinoxalinamine; 5-Bromo-6aminoquinoxaline | 25MG,50MG | Refrigerator | 50358-63-9 | 224.06 | C8H6BrN3 | NA | Brimonidine – Impurity B |
PA 02 44030 | Quinoxalin-6-amine | IMPC | 6-Quinoxalinamine; (Quinoxalin-6yl)amine; 6-Aminoquinoxaline; | 25MG,50MG | NA | 6298-37-9 | 145.16 | C8H7N3 | 6-Amino-quinoxaline;; 6- Quinoxalylamine; NSC 41810; | Brimonidine – Impurity C |
PA 02 44050 | 1-(5-Bromoquinoxalin-6- yl)guanidine | IMPE | Guanidine, 1-(5-bromoquinoxalin6-yl); | 25MG,50MG | NA | 168329-48-4 2 | 266.1 | C9H8BrN5 | NA | Brimonidine – Impurity E |
PA 02 44051 | N-(5-Bromo-6- quinoxalinyl)quanidine Hydrochloride | IMPE | N-(5-Bromo-6quinoxalinyl)guanidine Hydrochloride; 1-(5Bromoquinoxalin-6-yl)guanidine Hydrochloride | 25MG,50MG | Hygroscop ic, Freezer, Under inert atmospher | 1797986-78-7 | 302.56 | C9H9BrClN5 | NA | Brimonidine – Impurity E (Hydrochloride) |
PA 02 44060 | 4,5-Didehydro Brimonidine | IMPF | 5-Bromo-N-1H-imidazol-2-yl-6quinoxalinamine; 5-Bromo-N-(1Himidazol-2-yl)quinoxalin-6-amine | 25MG,50MG | NA | 151110-15-5 2 | 290.12 | C11H8BrN5 | NA | Brimonidine – Impurity F |
PA 02 44070 | 1-(2-Aminoethyl)-3-(5- bromoquinoxalin-6-yl)urea |
IMPG | (5-Bromoquinoxalin-6-yl)urea, 1(2-aminoethyl)-3-; | 25MG,50MG | NA | NA | 310.15 | C11H12BrN5O | NA | Brimonidine – Impurity G |
PA 02 44510 | Brimonidine L-Tartrate | IH | 5-Bromo-N-(4,5-dihydro-1H-imidazol-2yl)-6-quinoxalinamine L-Tartrate; Brimonidine Tartrate | 25MG,50MG | Freezer | 70359-46-5 | 442.22 | C15H16BrN5O6 | 5-Bromo-6-(2-imidazolin-2- ylamino)quinoxaline; UK-14304- 18; AGN-190342-LF; Alphagan; | Brimonidine – In house impurity |
PA 02 44520 | 5-Bromoquinazolin-6-ylthiourea | IMPD | N-(5-Bromo-6-quinoxalinyl)thiourea; (5Bromo-6-quinoxalinyl)thiourea | 25MG,50MG | Refrigerator | 842138-74-3 | 283.15 | C9H7BrN4S | NA | Brimonidine – Impurity D |
PA 02 44530 | N-tert-Butyloxycarbonyl Hydroxy Brimonidine | IH | tert-Butyl (2-(3-(5-bromoquinoxalin-6yl)ureido)ethyl)carbamate; | 25MG,50MG | Refrigerator | 1391053-57-8 | 410.27 | C16H20BrN5O3 | NA | Brimonidine – In house impurity |
PA 02 44540 | Hydroxy Brimonidine Trifluoroacetate Salt | IH | Hydroxy Brimonidine Trifluoroacetic Acid Salt; 1-(2-Aminoethyl)-3-(5bromoquinoxalin-6-yl)urea 2,2,2trifluoroacetate | 25MG,50MG | Refrigerator | 1391054-10-6 | 424.17 | C13H13BrF3N5O3 | NA | Brimonidine – In house impurity |
PA 02 80000 | Brinzolamide | API | (R)-4-(Ethylamino)-3,4-dihydro-2-(3methoxypropyl)-2H-Thieno[3,2-e]-1,2thiazine-6-sulfonamide 1,1-dioxide; AL 4862; | 25MG,50MG | Freezer | 138890-62-7 | 383.51 | C12H21N3O5S3 | NA | Brinzolamide – API |
PA 02 80030 | O-Desmethyl Brinzolamide | IMPC | (R)-4-(Ethylamino)-3,4-dihydro-2-(3hydroxypropyl)-2H-thieno[3,2-e]-1,2thiazine-6-sulfonamide 1,1-dioxide | 25MG,50MG | NA | 186377-56-0 | 369.48 | C11H19N3O5S3 | (R)-4-(Ethylamino)-2-(3- hydroxypropyl)-3,4-dihydro-2Hthieno[3,2-e][1,2]thiazine-6- sulfonamide 1,1-dioxide; | Brinzolamide – Impurity C |
PA 02 80510 | (S)-Brinzolamide | IH | (S)-4-(Ethylamino)-3,4-dihydro-2(3-methoxypropyl)-2H-thieno[3,2e]-1,2-thiazine-6-sulfonamide 1,1Dioxide; | 25MG,50MG | NA | 186377-56-0 | 383.51 | C12H21N3O5S3 | NA | Brinzolamide – In house impurity |
PA 02 80520 | Brinzolamide Methanesulfonyl Amide | IH | ((4R)-4Ethyl(methylsulfonyl)amino-2-(3methoxypropyl)-3,4-dihydro-2Hthieno[3,2-e]-1,2-thiazine-6sulfonamide-1,1-dioxide; (R)-4-(NEthylmethylsulfonamido)-2-(3methoxypropyl)-3,4-dihydro-2H | 25MG,50MG | NA | NA | 461.6 | C13H23N3O7S4 | NA | Brinzolamide – In house impurity |
PA 02 80530 | Brinzolamide Isopropyl Impurity | IH | (4R)-4-(Isopropylamino)-2-(3methoxypropyl)-3,4-dihydro-2Hthieno[3,2-e]-1,2-thiazine-6sulfonamide-1,1-dioxide; NDesethyl N-Isopropyl Brinzolamide; (R)-4(Isopropylamino)-2-(3 | 25MG,50MG | NA | NA | 397.53 | C13H23N3O5S3 | NA | Brinzolamide – In house impurity |
PA 02 45000 | Brivanib | API | 1-[[4-[(4-Fluoro-2-methyl-1H-indol5-yl)oxy]-5-methylpyrrolo[2,1f][1,2,4]triazin-6-yl]oxy]-2propanol | 25MG,50MG | NA | 649735-46-6 | 370.38 | C19H19FN4O3 | (R)-1-((4-((4-Fluoro-2-methyl1H-indol-5-yl)oxy)-5- methylpyrrolo[2,1- f][1,2,4]triazin-6- yl)oxy)propan-2-ol; | Brivanib – API |
PA 02 45510 | Brivanib Alaninate | IH | L-Alanine (1R)-2-[[4-[(4-fluoro-2-methyl1H-indol-5-yl)oxy]-5-methylpyrrolo [2,1f][1,2,4]triazin-6-yl]oxy]-1-methylethyl Ester; BMS 582664; | 25MG,50MG | NA | 649735-63-7 | 441.46 | C22H24FN5O4 | NA | Brivanib – In house impurity |
PA 02 46000 | Bromazepam | API | 7-Bromo-1,3-dihydro-5-(2-pyridinyl)-2H1,4-benzodiazepin-2-one; Compendium | 25MG,50MG | NA | 1812-30-2 | 316.15 | C14H10BrN3O | Creosedin; Durazanil; Lexilium; Lexomil; Lexotan; Lexotanil; NSC 140669; Normoc; |
Bromazepam – API |
PA 02 84000 | Brombuterol | API | 4-Amino-3,5-dibromo-α-[[(1,1dimethylethyl)amino]methyl]benzenemet hanol; 1-(4-Amino-3,5-dibromophenyl)-2(tert-butylamino)ethanol; Bromobuterol | 25MG,50MG | Hygroscopic, Refrigerator, under inert atmosphere |
41937-02-4 3 | 366.09 | C12H18Br2N2O | NA | Brombuterol – API |
PA 02 47000 | Bromfenac Sodium | API | 2-Amino-3-(4bromobenzoyl)benzeneacetic acid sodium salt; | 25MG,50MG | Room Temp | 91714-93-1 | 356.15 | C15H11BrNNaO3 | NA | Bromfenac Sodium – API |
PA 02 47510 | 2-Amino-3-(4-bromobenzoyl)benzoic Acid | IH | 2-Amino-3-(4-bromobenzoyl)benzoic Acid; | 25MG,50MG | NA | 241496-82-2 | 320.14 | C14H10BrNO3 | NA | Bromfenac Sodium – In house impurity |
PA 02 48000 | Bromhexine Hydrochloride | API | 2-Amino-3,5-dibromo-N-cyclohexyl-Nmethylbenzenemethanamine Hydrochloride; Ophtosol; Quentan; | 25MG,50MG | Refrigerator | 611-75-6 | 412.59 | C14H21Br2ClN2 | 3,5-Dibromo-Nα-cyclohexyl-Nαmethyltoluene-α,2-diamine Monohydrochloride; Auxit; Bisolvon; Bisolvon Hydrochloride; N-Cyclohexyl-N-methyl-N-(2- amino-3,5- dibromobenzyl)ammonium | Bromhexine Hydrochloride – API |
PA 02 48010 | (2-Amino-3,5-dibromophenyl)methanol | IMPA | 2-Amino-3,5-dibromobenzyl Alcohol | 25MG,50MG | Refrigerator | 50739-76-9 2 | 280.94 | C7H7Br2NO | NA | Bromhexine Hydrochloride – Impurity A |
PA 02 48020 | 2-Amino-3,5-dibromo-benzaldehyde | IMPB | 2-Amino-3,5-dibromobenzaldehyde; 3,5Dibromo-2-aminobenzaldehyde; 2Amino-3,5-dibromobenzaldehyde | 25MG,50MG | Freezer | 50910-55-9 | 278.93 | C7H5Br2NO | NA | Bromhexine Hydrochloride – Impurity B |
PA 02 48030 | N-(2-Aminobenzyl)-Nmethylcyclohexanamine | IMPC | 2-Amino-N-cyclohexyl-Nmethylbenzenemethanamine; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 57365-08-9 | 218.34 | C14H22N2 | Nα-cyclohexyl-Nα- methyltolueneα,2-diamine; 2- [(Cyclohexylmethylamino)methyl]p henylamine; N-(2-Aminobenzyl)-Nmethylcyclohexanamine; | Bromhexine Hydrochloride – Impurity C |
PA 02 48040 | 2-Amino-5-bromo-N-cyclohexyl-Nmethylbenzylamine Dihydrochloride | IMPD | 2-Amino-5-bromo-N-cyclohexyl-Nmethylbenzenemethanamine Hydrochloride; N- | 25MG,50MG | NA | 10076-98-9 | 370.16 | C14H23BrCl2N2 | 5-Bromo-Nα-cyclohexyl-Nαmethyltoluene-α,2-diamine Dihydrochloride; | Bromhexine Hydrochloride – Impurity D |
PA 02 48050 | 3-Cyclohexyl-6,8-dibromo-3-methyl1,2,3,4-tetrahydroquinazolinium | IMPE | (3RS)-6,8-Dibromo-3-cyclohexyl-3methyl-1,2,3,4-tetrahydroquinazolin-3ium | 25MG,50MG | NA | NA | 389.15 | C15H21Br2N2 | NA | Bromhexine Hydrochloride – Impurity E |
PA 02 48510 | N-(2-Nitrobenzyl)-N-cyclohexyl-Nmethylamine | IH | N-Methyl-N-(2nitrobenzyl)cyclohexanamine; | 25MG,50MG | NA | 80638-08-0 | 248.32 | C14H20N2O2 | NA | Bromhexine Hydrochloride – In house impurity |
PA 02 48520 | Bromhexine N-Oxide | IH | N-(2-Amino-3,5-dibromobenzyl)N-methylcyclohexanamine Oxide | 25MG,50MG | NA | NA | 392.13 | C14H20Br2N2O | NA | Bromhexine Hydrochloride – In house impurity |
PA 02 48530 | 6,8-Dibromo-3-cyclohexyl-3,4-dihydro2(1H)-quinazolinone | IH | 6,8-Dibromo-3-cyclohexyl-3,4dihydroquinazolin-2(1H)-one | 25MG,50MG | NA | 21237-84-3 | 388.1 | C14H16Br2N2O | NA | Bromhexine Hydrochloride – In house impurity |
PA 02 49000 | Bromocriptine | API | (5′α)-2-bromo-12′-hydroxy-5′-(2methylpropyl)-3′,6′,18-trioxo-2′-(propan-2yl)ergotaman; 2-Bromoergocryptine; 2Bromo α-Ergocryptine; | 25MG,50MG | NA | 25614-03-3 | 654.59 | C32H40BrN5O5 | 2-Bromo-a-ergokryptine; (5’α)-2- Bromo-12′-hydroxy-2′-(1- methylethyl)-5′-(2- methylpropyl)ergotaman-3′,6′,18- trione; | Bromocriptine – API |
PA 02 49020 | α-Ergocryptine | Imp B | (6aR,9R)-N-[(2R,5S,10aS,10bS)- 10b-Hydroxy-2-(1-methylethyl)-5- (2-methylpropyl)-3,6- dioxooctahydro-8H-oxazolo[3,2- a]pyrrolo[2,1-c]pyrazin-2-yl]-7- methyl-4,6,6a,7,8,9- hexahydroindolo[4,3-fg]quinoline9-carboxamide; | 25MG,50MG | Hygroscop ic, Freezer, Under inert atmospher e | 511-09-1 | 575.7 | C32H41N5O5 | (5’α)-12’-Hydroxy-2’-(1- methylethyl)-5’-(2- methylpropyl)ergotaman3’,6’,18-trione; Ergocryptine; Ergokryptine; αErgocryptine; αErgokryptine; | Bromocriptine – Impurity B |
PA 02 49510 | Bromocriptine Mesylate | IH | Bromocriptine Methanesulfonate; 2- Bromo α-Ergocryptine Mesylate; (5’α)-2- Bromo-12′-hydroxy-2′-(1-methylethyl)-5′- (2-methylpropyl)ergotaman-3′,6′,18- trione Methanesulfonate; | 25MG,50MG | Freezer | 22260-51-1 | 750.7 | C33H44BrN5O8S | 2-Bromoergocryptine; Bagren; Bromocriptine Methanesulfonate; Bromocryptine Mesylate; CB 154; Parlodel; Pravidel; | Bromocriptine – In house impurity |
PA 02 50000 | Bromisoval | API | 2-Bromo-3-methylbutyrylurea; N- (Aminocarbonyl)-2-bromo-3-methylbutanamide; (2-Bromo-3-methylbutyryl)- urea; RS)-2-Bromoisovalerylurea; Bromoxil; Bromural; Bromuvan; Bromvalerylurea; Bromvaletone; Bromvalurea; Bromyl; Brovalin; Brovalurea; Brovarin; Calmotin; Dagrabromyl; Dibroluur; Dormigene; |
25MG,50MG | Refrigerator, Under Inert Atmosphere | 496-67-3 | 223.07 | C6H11BrN2O2 | (±)-Bromisoval; (αBromoisovaleryl)urea; 2- Bromoisovalerylurea; Abroval; Alluval; Alural; BVU; Bromaral; Bromcarbamide; Bromisoval; Bromisovalerylurea; Bromisovalum; Bromizoval; Bromocarbamide; Bromoisovalum; Bromoval; Bromovalerocarbamide; | Bromisoval – API |
PA 02 50510 | Ethyl 2-Bromoisovalerate | IH | 2-Bromo-3-methylbutanoic Acid Ethyl Ester; 2-Bromo-3-methylbutyric Acid Ethyl Ester; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 609-12-1 | 209.08 | C7H13BrO2 | Ethyl 2-Bromo-2-isopropylacetate; Ethyl 2-Bromo-3-methylbutanoate; Ethyl 2-Bromo-3-methylbutyrate; Ethyl α-Bromoisovalerate; NSC 8866; α-Bromoisovaleric Acid Ethyl | Bromisoval – In house impurity |
PA 02 51000 | Bromopride | API | 4-Amino-5-bromo-N-[2- (diethylamino)ethyl]-2- methoxybenzamide; | 25MG,50MG | Refrigerator | 4093-35-0 | 344.25 | C14H22BrN3O2 | 2-Methoxy-4-amino-5-bromo-N,Ndiethylaminoethylbenzamide; NDiethylaminoethyl-2-methoxy-4- amino-5-bromobenzamide; Emepride; Emoril; Viadil | Bromopride – API |
PA 02 51510 | Alloc Bromoridane | IH | trans-2-(3-Bromo-2-oxopropyl)-3- methoxy-1-piperidinecarboxylic Acid 2- Propenyl Ester; Allyl Bromoridane | 25MG,50MG | Hygroscopic, Freezer, Under Inert Atmosphere | 117348-70-6 | 334.21 | C13H20BrNO4 | Bromoridane N-Carboxylic Acid Allyl Ester; | Bromopride – In house impurity |
PA 02 51520 | 2-Amino-3-bromo-5,6-dimethylpyridine | IH | 3-Bromo-5,6-dimethyl-2-pyridinamine; | 25MG,50MG | NA | 161091-49-2 | 201.06 | C7H9BrN2 | NA | Bromopride – In house impurity |
PA 02 51530 | 2-Amino-3-bromo-5-methylpyridine | IH | 3-Bromo-5-methyl-2-pyridinamine; 6- Amino-5-bromo-3-picoline; | 25MG,50MG | NA | 17282-00-7 | 187.04 | C6H7BrN2 | NA | Bromopride – In house impurity |
PA 02 51540 | 5-Amino-3-bromo-2-methoxypyridine | IH | 5-Bromo-6-methoxy-3-pyridinamine; | 25MG,50MG | NA | 53242-18-5 | 203.04 | C6H7BrN2O | NA | Bromopride – In house impurity |
PA 02 51550 | 2-Amino-3-bromo-5-phenylpyridine | IH | 3-Bromo-5-phenyl-2-pyridinamine | 25MG,50MG | NA | 107351-80-4 | 249.11 | C11H9BrN2 | NA | Bromopride – In house impurity |
PA 02 51560 | 2-Amino-3-bromopyridine-5-sulfonic Acid | IH | 6-Amino-5-bromo-3-pyridinesulfonic Acid; Pyridin-2-amino-3-bromo-5- sulfonic Acid; | 25MG,50MG | Refrigerator | 247582-62-3 | 253.07 | C5H5BrN2O3S | NA | Bromopride – In house impurity |
PA 02 51570 | 1,3-Bis(2’bromo-4’-cyanophenoxy)propane | IH | 4,4′-[1,3-Propanediylbis(oxy)]bis[3- bromo-benzonitrile; | 25MG,50MG | NA | 93840-60-9 | 436.1 | C17H12Br2N2O2 | NA | Bromopride – In house impurity |
PA 02 51580 | 3-Bromoaniline | IH | 3-Bromo-benzenamine; (3- Bromophenyl)amine; (mBromophenyl)amine; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 591-19-5 | 172.02 | C6H6BrN | 1-Amino-3-bromobenzene; NSC 10298; m-Aminobromobenzene; | Bromopride – In house impurity |
PA 02 51590 | 3-Bromo-7-azaindole | IH | 3-Bromo-pyrrolo[2,3-b]pyridine; | 25MG,50MG | NA | 74420-15-8 | 197.03 | C7H5BrN2 | NA | Bromopride – In house impurity |
PA 02 51600 | 3-Bromobenzene-1,2-diamine | IH | 3-Bromo-1,2-benzenediamine; 3-Bromoo-phenylenediamine; | 25MG,50MG | NA | 1575-36-6 | 187.04 | C6H7BrN2 | 1,2-Diamino-3-bromobenzene; 2- Amino-3-bromoaniline; 3-Bromo1,2-diaminobenzene; 3-Bromo-ophenylenediamine; | Bromopride – In house impurity |
PA 02 51610 | 3-Bromo-2-methylbenzoic Acid Methyl Ester | IH | Methyl 3-Bromo-2-methylbenzoate; 3- Bromo-o-toluic Acid Methyl Ester; | 25MG,50MG | NA | 99548-54-6 | 229.07 | C9H9BrO2 | NA | Bromopride – In house impurity |
PA 02 51620 | 3-Bromo-2-cyanopyridine | IH | 3-Bromo-2-pyridinecarbonitrile; 2-Cyano3-bromopyridine; | 25MG,50MG | Freezer, Under Inert Atmosphere | 55758-02-6 | 183.01 | C6H3BrN2 | 3-Bromopicolinonitrile; | Bromopride – In house impurity |
PA 02 51630 | 3-Bromo-5-cyanopyridine | IH | 5-Bromonicotinonitrile; 5-Bromo-3- pyridinecarbonitrile; | 25MG,50MG | Freezer, Under Inert Atmosphere | 35590-37-5 | 183.01 | C6H3BrN2 | 3-Cyano-5-bromopyridine; 5- Bromo-3-cyanopyridine | Bromopride – In house impurity |
PA 02 51640 | 2-Bromo-1-(4’-methoxy-3’- sulfonamidophenyl)-1-propanone | IH | 3’-Sulphonamido-4’-methoxyphenyl-3- bromo-2-propione; 5-(2-Bromo-1- oxopropyl)-2- methoxybenzenesulfonamide; | 25MG,50MG | NA | 86225-70-9 | 322.18 | C10H12BrNO4S | NA | Bromopride – In house impurity |
PA 02 52000 | Brompheniramine Maleate | API | γ-(4-Bromophenyl)-N,N-dimethyl-2- pyridinepropanamine Maleate; 2-[pΒromo-α-[2- (dimethylamino)ethyl]benzyl]pyridine Maleate; (+/-)-Brompheniramine Maleate; Bromphen Maleate; | 25MG,50MG | Refrigerator | 980-71-2 | 435.31 | C20H23BrN2O4 | Dimegan; Dimetane; Parabromdylamine Maleate; Parabromodylamine Maleate; Veltane; dl-Brompheniramine Maleate; | Brompheniramine Maleate – API |
PA 02 52010 | Chlorphenamine Maleate | IMPA | 2-[p-Chloro-α-(2-dimethylaminoethyl)benzyl]pyridine Maleate Salt; 1-(p-Chlorophenyl)-1-(2-pyridil)-3- dimethylaminopropane Maleate Salt | 25MG,50MG | Freezer | 113-92-8 | 390.86 | C20H23ClN2O4 | Allergisan; Piriton; Teldrin | Brompheniramine Maleate – Impurity A |
PA 02 52020 | [3-(11,12-Dihydro-6H-dibenzo[b,f]azocin-5- yl)-propyl]-dimethyl-amine | Imp B | (S)-Chlorpheniramine Maleate Salt; (γS)- γ-(4-Chlorophenyl)-N,N-dimethyl-2- pyridinepropanamine (2Z)-2- Butenedioate; Polaronil; dChlorpheniramine Maleate; Polaramin; Polaramine; | 25MG,50MG | Refrigerator | 2438-32-6 | 390.86 | C20H23ClN2O4 | 2-[p-Chloro-α-[2- (dimethylamino)ethyl]benzyl]pyridin e Maleate; (+)-Chlorpheniramine Maleate; Dexchloropheniramine Maleate; Dextrochlorpheniramine Maleate; Fortamine; Isomerine; | Brompheniramine Maleate – Impurity B |
PA 02 52030 | (3RS)-N,N-Dimethyl-3-phenyl-3-(pyridin-2- yl)propan-1-amine (Pheniramine) | Imp C | 1-Phenyl-1-(2-pyridyl)-3- dimethylaminopropane Maleate; 2-[α-[2- (Dimethylamino)ethyl]benzyl]pyridine Maleate; Antolozine; | 25MG,50MG | Refrigerator | 132-20-7 | 356.42 | C20H24N2O4 | Daneral; Fervex; Inhiston; Metron; Naphcon A; PM 241; Pheniramine Hydrogen Maleate; Trimeton; Trimetose; N,N-Dimethyl-γ-phenyl2-pyridinepropanamine (2Z)-2- Butenedioate; | Brompheniramine Maleate – Impurity C |
PA 02 52510 | Brompheniramine N-Oxide | IH | 3-(4-Bromophenyl)-N,N-dimethyl-3- (pyridin-2-yl)propan-1-amine Oxide; | 25MG,50MG | NA | 18453-29-7 | 335.24 | C16H19BrN2O | NA | Brompheniramine Maleate – In house impurity |
PA 02 52520 | Desmethylbrompheniramine Maleate | IH | 3-(4-Bromophenyl)-N-methyl-3- (pyridin-2-yl)propan-1-amine Maleate; | 25MG,50MG | NA | 18453-10-6 | 421.29 | C19H21BrN2O4 | NA | Brompheniramine Maleate – In house impurity |
PA 02 53000 | Buclizine | API | (RS)-1-[(4-Chlorophenyl)-phenyl-methyl]- 4-[(4-tert-butylphenyl) methyl] piperazine | 25MG,50MG | NA | 82-95-1 | 433.03 | C28H33ClN2 | 1-(4-(tert-butyl)Benzyl)-4-((4- chlorophenyl)(phenyl)methyl)piper azine | Buclizine – API |
PA 02 53010 | 1,4-Bis[(4- chlorophenyl)phenylmethyl]piperazine | Imp A | 1,4-Bis[(4- chlorophenyl)phenylmethyl]piperazine | 25MG,50MG | NA | 346451-15-8 | 487.46 | C30H28Cl2N2 | NA | Buclizine – Impurity A |
PA 02 53510 | 4-Chlorobenzhydrol | IH | 4-chloro-α-phenyl-benzenemethano; (4- Chlorophenyl)phenylmethanol; | 25MG,50MG | Room Temp | 119-56-2 | 218.68 | C13H11ClO | NSC 59990; p-Chlorobenzhydrol; α-(4-Chlorophenyl)benzyl Alcohol; | Buclizine – In house impurity |
PA 02 53520 | 4-Chlorobenzophenone | IH | (4-Chlorophenyl)phenylmethanone; 4- Benzoylphenyl Chloride; | 25MG,50MG | NA | 134-85-0 | 216.66 | C13H9ClO | 4-CBP; 4-Chlorobenzophenone; 4- Chlorophenyl Phenyl Ketone; CBP; Initiator 1046; NSC 2872; Phenyl 4- Chlorophenyl Ketone; p-CBP; pChlorobenzophenone; pChlorophenyl Phenyl Ketone; | Buclizine – In house impurity |
PA 02 53530 | (R)-1-[(4- Chlorophenyl)phenylmethyl]piperazine | IH | (-)-1-[(4- Chlorophenyl)phenylmethyl]piperazine; (R)-1-(p-Chlorobenzhydryl)piperazine; | 25MG,50MG | NA | 300543-56-0 | 286.8 | C17H19ClN2 | NA | Buclizine – In house impurity |
PA 02 99000 | Buclizine Dihydrochloride | API | Buclina; Longifene; Posdel; Vibazine; (RS)-1-[(4- Chlorophenyl)-phenyl-methyl]-4- [(4-tert-butylphenyl) methyl] piperazine Dihydrochloride | 25MG,50MG | Freezer | 129-74-8 | 505.95 | C28H37Cl3N2 | NA | Buclizine Dihydrochloride – API |
PA 02 54000 | Budesonide | API | (11β,16α)-16,17-[Butylidenebis(oxy)]- 11,21-dihydroxypregna-1,4-diene-3,20- dione; | 25MG,50MG | Freezer | 51333-22-3 | 430.53 | C25H34O6 | (11β,16α)-16,17- [Butylidenebis(oxy)]-11,21- dihydroxypregna-1,4-diene-3,20- dione; Bidien; Budenofalk; Budesomide; Budeson; Cortivent; Entocort; Micronyl; Nebuampul; Preferid; Pulmicort; Respules; Rhinocort; Rhinocort Aqua; S 1320; Spirocort; Turbuhaler; | Budesonide – API |
PA 02 54010 | 11,16,17,21-Tetrahydroxy-pregna-1,4- diene-3,20-dione | Imp A | (11β,16α)-11,16,17,21- Tetrahydroxypregna-1,4-diene-3,20- dione; 16α-Hydroxyprednisolone; 16- Hydroxy-prednisolone; | 25MG,50MG | Freezer | 13951-70-7 | 376.44 | C21H28O6 | NA | Budesonide – Impurity A |
PA 02 54020 | 16α,17-[(1RS)-Ethylidenebis(oxy)]-11β,21- dihydroxypregna-1,4-diene-3,20-dione | Imp B | (11β,16α)-16,17-[(1RS)- Ethylidenebis(oxo)]-11,21- dihydroxypregna-1,4-diene-3,20-dione; DHomobudesonide; Di-Norbudesonide (Mixture of Diastereomers) | 25MG,50MG | Freezer | 1040085-98-0 | 402.48 | C23H30O6 | NA | Budesonide – Impurity B |
PA 02 54030 | 16α,17-[(1RS)-Butylidenebis(oxy)]-11βhydroxy-17-(hydroxymethyl)-Dhomoandrosta-1,4-diene-3,17a-dione (Mixture of Diastereomers) | Imp C | 5-Hydroxy-6b-(2-hydroxy-acetyl)-4a,6adimethyl-8-propyl4a,4b,5,6,6a,6b,9a,10b,11,12-decahydro7,9-dioxa-pentaleno[2,1-a]phenanthren-2- one; | 25MG,50MG | NA | 1040085-99-1 | 430.53 | C25H34O6 | (4aR,4bS,5S,6aS,7aR,10aR,11aS, 11bS)- 4b,6,6a,7a,10a,11,11a,11b,12,13- Decahydro-5-hydroxy-7a- (hydroxymethyl)-4a,6a-dimethyl-9- propylchryseno[2,3-d][1,3]dioxole2,7(4aH,5H)-dione; | Budesonide – Impurity C |
PA 02 54040 | 16a,17-[(1RS)-butylidenebis(oxy)]-11bhydroxy-3,20-dioxopregna-1,4-dien-21-al | Imp D | (11β,16α)-16,17-[Butylidenebis(oxy)]-11- hydroxy-3,20-dioxopregna-1,4-dien-21- al; | 25MG,50MG | Refrigerator | 85234-63-5 | 428.52 | C25H32O6 | NA | Budesonide – Impurity D |
PA 02 54050 | 14,15-Dehydro Budesonide | Imp E | 16α,17-[(1RS)-Butylidenebis(oxy)]- 11β,21-dihydroxypregna-1,4,14-triene3,20-dione; (11β,16α)-16,17- [Butylidenebis(oxy)]-11,21- dihydroxypregna-1,4,14-triene-3,20- dione; | 25MG,50MG | Freezer | 131918-64-4 | 428.52 | C25H32O6 | Budesonide Related Compound E; | Budesonide – Impurity E |
PA 02 54060 | Desonide | Imp F | (11β,16α)-11,21-Dihydroxy-16,17-[(1- methylethylidene)bis(oxy)]pregna-1,4- diene-3,20-dione; 16αHydroxyprednisolone Acetonide; | 25MG,50MG | Refrigerator | 638-94-8 | 416.51 | C24H32O6 | Locapred; Topifug; Tridesilon; 16α,17-[1- Methylethylidenebis(oxy)]-11β,21- dihydroxypregna-1,4-diene-3,20- dione; | Budesonide – Impurity mistake |
PA 02 54070 | 1,2-Dihydro Budesonide | Imp G | 16α,17-[(1RS)-Butylidenebis(oxy)]- 11β,21-dihydroxypregn-4-ene-3,20- dione; 16alpha,17-[butylidenebis(oxy)]- 11beta,21-dihydroxypregna-4-ene-3,20- dione; | 25MG,50MG | Freezer, Under inert atmosphere | 137174-25-5 | 432.55 | C25H36O6 | 16α,17-[butylidenebis(oxy)]-11β, 21-dihydroxypregna-4-ene-3,20- dione; (11β,16α)-16,17- [Butylidenebis(oxy)]-11,21- dihydroxypregn-4-ene-3,20-dione; Budesonide Related Compound G; | Budesonide – Impurity G |
PA 02 54080 | 9,11-Anhydro Budesonide | Imp H | 9,11-Anhydrobudesonide (Mixture of Diastereomers); 16α,17-[(1RS)- Butylidenebis(oxy)]-21-hydroxypregna1,4,9(11)-triene-3,20-dione; (16α)-16,17- [Butylidenebis(oxy)]-21-hydroxy-pregna1,4,9(11)-triene-3,20-dione; | 25MG,50MG | Freezer, Under inert atmosphere | 313474-58-7 | 412.52 | C25H32O5 | NA | Budesonide – Impurity H |
PA 02 54090 | 16α-Butyloxy Prednisolone | Imp I | 16α-Butyloxyprednisolone; 11β,17,21- Trihydroxy-3,20-dioxopregna-1,4-dien16α-yl butanoate; 16α- (Butyryloxy)prednisolone | 25MG,50MG | NA | 113930-13-5 | 446.53 | C25H34O7 | (11β,16α)-11,17,21-Trihydroxy-16- (1-oxobutoxy)-pregna-1,4-diene3,20-dione; 16αHydroxyprednisolone 16-Butyrate; | Budesonide – Impurity I |
PA 02 54100 | 9α-Bromo Budesonide | Imp J | 16α,17-[(1RS)-Butylidenebis(oxy)]-9αbromo-11β,21-dihydroxypregna-1,4- diene-3,20-dione; 9αBromobudesonide; 9-Bromo-16,17- [butylidenebis(oxy)]-11,21-dihydroxy- (11β,16α)-pregna-1,4-diene-3,20-dione; | 25MG,50MG | NA | 313474-59-8 | 509.43 | C25H33BrO6 | NA | Budesonide – Impurity J |
PA 02 54110 | Budesonide 21-acetate | Imp K | 21-Acetoxy-11β-hydroxy-16α,17αpropylmethylenedioxpregna-1,4-diene3,20-dione; 21-Acetyloxy Budesonide; | 25MG,50MG | Refrigerator | 51333-05-2 | 472.57 | C27H36O7 | (11β,16α)-21-(Acetyloxy)-16,17- [butylidenebis(oxy)]-11-hydroxypregna-1,4-diene-3,20-dione; | Budesonide – Impurity K |
PA 02 54510 | 21-Butyryloxy Budesonide | IH | Budesonide 21-butyrate; 16α,17-[(1RS)- Butylidenebis(oxy)]-11β,21- dihydroxypregna-1,4-diene-3,20-dione21-butyrate; | 25MG,50MG | Freezer | NA | 500.62 | C29H40O7 | 2- ((6aR,6bS,7S,8aS,8bS,11aR,12aS ,12bS)-7-Hydroxy-6a,8a-dimethyl4-oxo-10-propyl2,4,6a,6b,7,8,8a,8b,11a,12,12a,12 b-dodecahydro-1Hnaphtho[2’,1’:4,5]indeno[1,2- d][1,3]dioxol-8b-yl)-2-oxoethyl Butyrate; | Budesonide – In house impurity |
PA 02 54520 | Desonide-21-aldehyde | IH | (11β,16α)-11-Hydroxy-16,17-[(1- methylethylidene)bis(oxy)]-3,20-dioxopregna-1,4-dien-21-al; (11beta,16alpha)- 11-Hydroxy-16,17-[(1- methylethylidene)bis(oxy)]-3,20-dioxopregna-1,4-dien-21-al; | 25MG,50MG | NA | 57171-18-3 | 414.49 | C24H30O6 | NA | Budesonide – In house impurity |
PA 02 54530 | 1,2-Dihydrodesonide | IH | 1,2-Dihydro Desonide; (11β,16α)-11,21- Dihydroxy-16,17-[(1- methylethylidene)bis(oxy)]pregn-4-ene3,20-dione; | 25MG,50MG | NA | 638-93-7 | 418.52 | C24H34O6 | 11β,21-Dihydroxy-16α,17- isopropylidenedioxy-4-pregnene3,20-dione; 16αHydroxyhydrocortisone 16,17- acetonid | Budesonide – In house impurity |
PA 02 54540 | Delta-9(11) Desonide | IH | Desonide Delta-9(11) Analog; 9- Desfluoro-11-dehydroxy-9(11)-ene Triamcinolone Acetonide; (16α)-21- Hydroxy-16,17-[(1- methylethylidene)bis(oxy)]-pregna1,4,9(11)-triene-3,20-dione; 16α,17,21- Trihydroxy-pregna-1,4,9(11)-triene-3,20- dione cyclic 16,17-acetal with acetone | 25MG,50MG | NA | 5541-37-7 | 398.49 | C24H30O5 | 2H-Naphth[2′,1′:4,5]indeno[1,2- d][1,3]dioxole Pregna-1,4,9(11)- triene-3,20-dione deriv.; 21- Hydroxy-16α,17α- (isopropylidenedioxy)pregna1,4,9(11)triene-3,20-dione; | Budesonide – In house impurity |
PA 02 54550 | Desonide 21-Acetate | IH | (11β,16α)-21-(Acetyloxy)-11-hydroxy16,17-[(1-methylethylidene)bis(oxy)]- pregna-1,4-diene-3,20-dione; | 25MG,50MG | NA | 25092-25-5 | 458.54 | C26H34O7 | NA | Budesonide – In house impurity |
PA 02 54560 | 11-Keto Budesonide | IH | 16alpha,17-[Butylidenebis(oxy)]-21- hydroxypregna-1,4-diene-3,11,20-trione; (16α)-16,17-[Butylidenebis(oxy)]-21- hydroxypregna-1,4-diene-3,11,20-trione; | 25MG,50MG | Freezer, Under inert atmosphere | 216453-74-6 | 428.52 | C25H32O6 | Budesonide Related Compound L; | Budesonide – In house impurity |
PA 02 55000 | Bufexamac | API | 4-Butoxy-N-hydroxybenzeneacetamide; Parfenal; Trolab; pButoxyphenylacethydroxamic Acid; pButoxyphenylacetohydroxamic Acid; 2-(4- Butoxyphenyl)-N-hydroxyacetamide; | 25MG,50MG | Refrigerator | 2438-72-4 | 223.27 | C12H17NO3 | 2-(pButoxyphenyl)acetohydroxamic Acid; 4- Butoxyphenylacethydroxamic Acid; Anderm; Bufexamic Acid; CP 1044J3; Droxarol; Droxaryl; | Bufexamac – API |
PA 02 55010 | 2-(4-Butoxyphenyl)acetic Acid | Imp A | Acetic Acid, 2-(4-Butoxyphenyl); | 25MG,50MG | NA | 4547-57-3 | 208.25 | C12H16O3 | NA | Bufexamac – Impurity A |
PA 02 55020 | Methyl 2-(4-Butoxyphenyl)-acetate | Imo B | Methyl 2-(4-Butoxyphenyl)acetate; | 25MG,50MG | NA | 29056-06-2 | 222.28 | C13H18O3 | NA | Bufexamac – Impurity B |
PA 02 55030 | Butyl 2-(4-Butoxyphenyl)-acetate | Imp C | Butyl 2-(4-Butoxyphenyl)acetate | 25MG,50MG | NA | NA | 264.36 | C16H24O3 | NA | Bufexamac – Impurity C |
PA 02 55040 | 2-(4-Butoxyphenyl)acetamide | Imp D | Acetamide, 2-(4-Butoxyphenyl); | 25MG,50MG | NA | 3413-59-0 | 207.27 | C12H17NO2 | NA | Bufexamac – Impurity D |
PA 02 55510 | 4′-Butoxyacetophenone | IH | Acetophenone, 4′-butoxy-; 1-(4- Butoxyphenyl)-ethanon | 25MG,50MG | NA | 5739-89-0 | 192.25 | C12H16O2 | 1-(4- BUTOXYACETOPHENONE ); | Bufexamac – In house impurity |
PA 02 55520 | Ethyl 2-(4-Butoxyphenyl)acetate | IH | Ethy (4-butoxyphenyl)acetate; 4547-58-4; Ethyl (4- butoxyphenyl)acetate; | 25MG,50MG | NA | NA | 236.3068 | C14H20O3 | AC1L2UXX, SureCN7484161, CTK1D7530, AC1Q6535, EINECS 224-905-7; | Bufexamac – In house impurity |
PA 02 56000 | Buflomedil Hydrochloride | API | 4-(1-Pyrrolidinyl)-1-(2,4,6- trimethoxyphenyl)-1-butanone Hydrochloride; | 25MG,50MG | Refrigerator | 35543-24-9 | 343.85 | C17H26ClNO4 | Bufedil; Buflan; Buflocit; Buflonat; Fonzylane; Irrodan; Irrodan R; LL 1656; Lofton; Loftyl; Provas | Buflomedil Hydrochloride – API |
PA 02 56510 | 4-(1-Pyrrolidino)butyronitrile | IH | 1-Pyrrolidinebutanenitrile; 4-Pyrrolidin-1- ylbutanenitrile; 4-(Pyrrolidin-1- yl)butanenitrile; | 25MG,50MG | NA | 35543-25-0 | 138.21 | C8H14N2 | NA | Buflomedil – In house impurity |
PA 02 56520 | 1,3,5-Trimethoxybenzene | IH | NSC 90060; Phloroglucinol Trimethyl Ether; sym-Trimethoxybenzene; | 25MG,50MG | NA | 621-23-8 | 168.19 | C9H12O3 | NA | Buflomedil – In house impurity |
PA 02 76000 | Bumetanide | API | 3-(Aminosulfonyl)-5-(butylamino)-4- phenoxy-benzoic Acid; 3-(Butylamino)-4- phenoxy-5-sulfamoylbenzoic Acid;Bufenox; | 25MG,50MG | Refrigerator | 28395-03-1 | 364.42 | C17H20N2O5S | Bumex; Burinex; Fordiuran; Lixil; Lunetoron; PF 1593; Ro 10-6338; | Bumetanide – API |
PA 02 76010 | 3-Nitro-4-phenoxy-5-sulfamoylbenzoic Acid | Imp A | 3-Nitro-4-phenoxy-5-sulfamoyl-benzoic Acid; 3-(Aminosulfonyl)-5-nitro-4- phenoxy-benzoic Acid; | 25MG,50MG | Refrigerator | 28328-53-2 | 338.29 | C13H10N2O7S | NA | Bumetanide – Impurity A |
PA 02 76020 | 3-Amino-4-phenoxy-5-sulfamoylbenzoic Acid | Imp B | Desbutyl Bumetanide; 3-Amino-5- (aminosulfonyl)-4-phenoxy-benzoic Acid; Desbutylbumetanide; | 25MG,50MG | Hygroscopic, Refrigerator, under inert atmosphere | 28328-54-3 | 308.31 | C13H12N2O5S | PF 1578; Bumetanide Related Compound A; | Bumetanide – Impurity B |
PA 02 76030 | Butyl 3-(butylamino)-4-phenoxy-5- sulfamoylbenzoate | Imp C | Bumetanide Butyl Ester; 3- (Aminosulfonyl)-5-(butylamino)-4- phenoxybenzoic Acid Butyl Ester | 25MG,50MG | NA | 32643-00-8 | 420.52 | C21H28N2O5S | 3-(Butylamino)-4-phenoxy-5- sulfamoylbenzoic Acid Butyl Ester; | Bumetanide – Impurity C |
PA 02 76040 | 3-((2-Ethylhexyl)amino)-4-phenoxy-5- sulfamoylbenzoic Acid | Imp D | N-Desbutyl-N-(2-ethylhexyl) Bumetanide; 3-[[(2RS)-2-Ethylhexyl]amino]-4-phenoxy5-sulfamoylbenzoic Acid; | 25MG,50MG | NA | 153012-65-8 | 420.52 | C21H28N2O5S | 3-(Aminosulfonyl)-5-[(2- ethylhexyl)amino]-4- phenoxybenzoic Acid; PF 2825; | Bumetanide – Impurity D |
PA 02 76510 | 4-Phenoxy-3-(propylamino)-5- sulfamoylbenzoic Acid | IH | 3-Aminosulfonyl-5-propylamino-4- phenoxybenzoic Acid; N-Desbutyl-Npropyl Bumetanide; 3-(Aminosulfonyl)-4- phenoxy-5-(propylamino)benzoic Acid; | 25MG,50MG | NA | 28395-28-0 | 350.39 | C16H18N2O5S | 4-Phenoxy-3-(propylamino)-5- sulfamoylbenzoic Acid; 4-Phenoxy3-propylamino-5-sulfamoylbenzoic Acid; | Bumetanide – In house impurity |
PA 02 76520 | 4-Chloro-3-nitro-5-sulfamoylbenzoic Acid | IH | 3-(Aminosulfonyl)-4-chloro-5-nitrobenzoic Acid; 4-Chloro-3-nitro-5- sulfamoyl-benzoic Acid; 5-Aminosulfonyl4-chloro-3-nitrobenzoic Acid; | 25MG,50MG | NA | 22892-96-2 | 280.64 | C7H5ClN2O6S | NA | Bumetanide – In house impurit |
PA 02 76530 | Methyl 4-chloro-3- {[(dimethylamino)methylene]sulfa moyl}-5-nitrobenzoate | IH | Methyl 4-chloro-3- (dimethylaminomethyleneamino)s ulfonyl-5-nitro-benzoate; Benzoic acid, 4-chloro-3- [[[(dimethylamino)methylene]ami no]sulfonyl]-5-nitro-, methyl Ester; | 25MG,50MG | NA | 60376-77-4 | 349.75 | C11H12ClN3O6S | NA | Bumetanide – In house impurit |
PA 02 57000 | Bunolol Hydrochloride | API | 5-[3-[(1,1-Dimethylethyl)amino]-2- hydroxypropoxy]-3,4-dihydro-1(2H)- naphthalenone Hydrochloride; | 25MG,50MG | NA | 31969-05-8 | 327.85 | C17H26ClNO3 | 5-(3-(Tert-butylamino)-2- hydroxypropoxy)-3,4- dihydronaphthalen-1(2H)-one Hydrochloride; (±)-Bunolol Hydrochloride; W 6412A; dlBunolol Hydrochloride | Bunolol Hydrochloride – API |
PA 02 58000 | Buphenine Hydrochloride | API | 4-Hydroxy-α-[1-[(1-methyl-3- phenylpropyl)amino]ethyl]benzenemetha nol; p-Hydroxy-N-(1-methyl-3- phenylpropyl)norephedrine; p-Hydroxy-N- (1-methyl-3-phenylpropyl)norphedrine; Phenyl-sec-butyl norsuprifen; Suprifen | 25MG,50MG | NA | 447-41-6 | *299.41 | C19H25NO2 | p-Hydroxy-α-[1-[(1-methyl-3- phenylpropyl)amino]ethyl]benzyl Alcohol; Nylidrin; 1-(4- Hydroxyphenyl)-2-[4-phenyl-2- butylamino]propan-1-ol; 1-(pHydroxyphenyl)-2-(1-methyl-3- | Buphenine Hydrochloride – API |
PA 02 59000 | Bupivacaine Hydrochloride Monohydrate | API | 1-Butyl-N-(2,6-dimethylphenyl)-2- piperidinecarboxamide; | 25MG,50MG | NA | 73360-54-0 | 342.9 | C18H31ClN2O2 | NA | Bupivacaine Hydrochloride Monohydrate – API |
PA 02 59010 | N-(2,6-Dimethylphenyl)-2- pyridinecarboxamide | Imp A | N-(2,6-Dimethylphenyl)-2- pyridinecarboxamide; 2′,6′- Picolinoxylidide; | 25MG,50MG | Refrigerator | 39627-98-0 | 226.27 | C14H14N2O | NA | Bupivacaine – Impurity A |
PA 02 59020 | N-Desbutyl Bupivacaine | Imp B | N-(2,6-Dimethylphenyl)-2- piperidinecarboxamide; 2’,6’- Pipecoloxylidide; 2’,6’-Pipecolylxylidine; Debutylbupivacaine; Desbutylbupivacaine; | 25MG,50MG | Freezer | 15883-20-2 | 232.32 | C14H20N2O | N-Desmethyl Mepivacaine; Bupivacaine Related Compound B; | Bupivacaine – Impurity B |
PA 02 59030 | 1-(2,6-Dimethylphenyl)-1,5,6,7-tetrahydro2H-azepin-2-one | Imp C | tetrahydro-2H-azepin-2-one, 1-(2,6- Dimethylphenyl)-1,5,6,7- | 25MG,50MG | NA | 1797894-80-4 | 215.29 | C14H17NO | Levobupivacaine Impurity C; | Bupivacaine – Impurity C |
PA 02 59040 | 2,6-Dichloro-N-(2,6- dimethylphenyl)hexanamide | Imp D | N-(2,6-Dichlorohexanoyl)-2,6- dimethylaniline; Levobupivacaine Impurity D; | 25MG,50MG | NA | 1037184-07-8 | 288.21 | C14H19Cl2NO | NA | Bupivacaine – Impurity D |
PA 02 59050 | 6-(Butylamino)-N-(2,6- dimethylphenyl)hexanamide | Imp E | N-(2,6-dimethylphenyl)hexanamide, 6- (Butylamino)-; | 25MG,50MG | NA | 1330172-81-0 | 290.44 | C18H30N2O | Bupivacaine Related Compound A | Bupivacaine – Impurity E |
PA 02 59060 | 2,6-Dimethylaniline | Imp F | 2,6-Dimethylbenzenamine; 2,6-DMA; 2,6- Xylidine; 1-Amino-2,6-dimethylbenzene; 2,6-Dimethylbenzenamine; 2,6- Dimethylphenylamine; | 25MG,50MG | Refrigerator | 87-62-7 | 121.18 | C8H11N | 2,6-Xylylamine; 2-Amino-1,3- dimethylbenzene; 2-Amino-1,3- xylene; 2-Amino-m-xylene; NSC 7098; o-Xylidine; Lidocaine impurity A; | Bupivacaine – Impurity F |
PA 02 59510 | 0 Bupivacaine N-Oxide Hydrochloride Salt | IH | Bupivacaine N-Oxide; Bupivacaine NOxide Hydrochloride Salt; | 25MG,50MG | Refrigerator | NA | 304.43 | C18H28N2O2 | NA | Bupivacaine – In house impurity |
PA 02 90000 | Buprenorphine | API | 5α,7α(S)]-17- (Cyclopropylmethyl)-α-(1,1- dimethylethyl)-4,5-epoxy-18,19- dihydro-3-hydroxy-6-methoxy-αmethyl-6,14-ethenomorphinan-7- methanol; | 25MG,50MG | NA | 52485-79-7 | 467.64 | C29H41NO4 | NA | Buprenorphine – API |
PA 02 90010 | (2S)-2-[17-(But-3-enyl)-4,5a-epoxy3-hydroxy-6- methoxy-6a,14- ethano-14a-morphinan-7a-yl]-3,3- dimethylbutan-2-ol | IMP A | (4R,4aS,6R,7R,7aR,12bS)-3-(But3-en-1-yl)-6-((S)-2-hydroxy-3,3- dimethylbutan-2-yl)-7-methoxy1,2,3,4,5,6,7,7a-octahydro-4a,7- ethano-4,12- methanobenzofuro[3,2- e]isoquinolin-9-ol; Buprenorphine Related compound A; | 25MG,50MG | NA | 457071-73-7 | 467.64 | C29H41NO4 | N-(3- Butenyl)norbuprenorphine; | Buprenorphine – Impurity A |
PA 02 90060 | 17-(Cyclopropylmethyl)-4,5αepoxy-6-methoxy-7α-[1-(1,1- dimethylethyl)ethenyl]-6α,14- ethano-14α-morphinan-3-ol | IMP F | (4R,4aS,6R,7R,7aR,12bS)-3- (Cyclopropylmethyl)-6-(3,3- dimethylbut-1-en-2-yl)-7-methoxy1,2,3,4,5,6,7,7a-octahydro-4a,7- ethano-4,12- methanobenzofuro[3,2- e]isoquinolin-9-ol; |
25MG,50MG | NA | NA | 449.62 | C29H39NO3 | NA | Buprenorphine – Impurity F |
PA 02 90070 | 2,2′-Bibuprenorphine | IMP G | 17,17′-Di(cyclopropylmethyl)- 4,5α;4′,5α’-diepoxy-7α,7α’-di[(1S)- 1-hydroxy-1,2,2-trimethylpropyl]- 6,6′-dimethoxy-2,2′-bi(6α,14- ethano-14α-morphinan)-3,3′-diol; | 25MG,50MG | NA | NA | 933.26 | C58H80N2O8 | (4R,4’R,5S,5’S,7R,7’R,8R,8′ R,9R,9’R,17S,17’S)-3,3′- Bis(cyclopropylmethyl)-7,7′- bis((S)-2-hydroxy-3,3- dimethylbutan-2-yl)-8,8′- dimethoxy2,2′,3,3′,4,4′,6,6′,7,7′,8,8′,9,9′ ,18,18′,19,19′,20,20′- | Buprenorphine – Impurity G |
PA 02 90080 | (2S)-2-[17-Butyl-4,5α-epoxy-3- hydroxy-6-methoxy-6α,14-ethano14α-morphinan-7α-yl]3,3- dimethylbutan-2-ol | IMP H | (4R,4aS,6R,7R,7aR,12bS)-3- Butyl-6-((S)-2-hydroxy-3,3- dimethylbutan-2-yl)-7-methoxy1,2,3,4,5,6,7,7a-octahydro-4a,7-l ethano-4,12- methanobenzofuro[3,2- e]isoquinolin-9-=ol; |
25MG,50MG | NA | NA | 469.66 | C29H43NO4 | NA | Buprenorphine – Impurity H |
PA 02 90100 | (2S)-2-[17-(Cyclopropylmethyl)- 4,5α-epoxy-3-hydroxy-6-methoxy6α,14-etheno-14α-morphinan-7αyl]-3,3-dimethylbutan-2-ol | IMP J | (4R,4aR,7R,7aR,12bS,14R)-3- (Cyclopropylmethyl)-14-((S)-2- hydroxy-3,3-dimethylbutan-2-yl)-7- methoxy-1,2,3,4,7,7a-hexahydro7,4a-ethano-4,12- methanobenzofuro[3,2- e]isoquinolin-9-ol; | 25MG,50MG | NA | NA | 465.62 | C29H39NO4 | NA | Buprenorphine – Impurity J |
PA 02 97000 | Buprenorphine Hydrochloride | API | [5α,7α(S)]-17- (Cyclopropylmethyl)-α-(1,1- dimethylethyl)-4,5-epoxy-18,19- dihydro-3-hydroxy-6-methoxy-αmethyl-6,14-ethenomorphinan-7- methanol Hydrochloride; | 25MG,50MG | NA | 53152-21-9 | 504.1 | C29H42ClNO4 | (4R,4aS,6R,7R,7aR,12bS)-3- (Cyclopropylmethyl)-6-((S)-2- hydroxy-3,3-dimethylbutan-2- yl)-7-methoxy1,2,3,4,5,6,7,7a-octahydro4a,7-ethano-4,12- methanobenzofuro[3,2- e]isoquinolin-9-ol | Buprenorphine Hydrochloride – API |
PA 02 60000 | Bupropion Hydrochloride | API | 1-(3-Chlorophenyl)-2-[(1,1- dimethylethyl)amino]-1-propanone Hydrochloride; (±)-Bupropion Hydrochloride; Amfebutamon Hydrochloride; | 25MG,50MG | Hygroscopic , Freezer, Under inert atmosphere |
31677-93-7 | 276.2 | C13H19Cl2NO | Amfebutamone Hydrochloride; Aplenzin Hydrochloride; Bupropion Hydrochloride; Bupropion SR Hydrochloride; Elontril Hydrochloride; α-(tert-Butylamino) | Bupropion Hydrochloride – API |
PA 02 60020 | 1-(3-Chlorophenyl)-1,2-propanedione | IMP B | 1-(m-Chlorophenyl)-1,2-propanedione; 1- (3-Chlorophenyl)propane-1,2-dione; | 25MG,50MG | Freezer | 10557-17-2 | 182.6 | C9H7ClO2 | Bupropion Related Compound E; | ; Bupropion – Impurity B |
PA 02 60070 | Bupropion 2′-Chloro Analog | IMP G | 2-[(1,1-Dimethylethyl)amino]-1-phenyl-1- propanone Hydrochloride; 2-(tertButylamino)propiophenon | 25MG,50MG | NA | 1049718-57-1 | 276.2 | C13H19Cl2NO | 2-(tert-Butylamino)-2′- chloropropiophenone hydrochloride; 2-(tert-Butylamino)- 2′-chloro-propiophenone Hydrochloride; | Bupropion – Impurity G |
PA 02 60100 | 2-(tert-Butylamino)-3’,5’- dichloropropiophenone Hydrochloride | IMP J | Bupropion 3′,5′-Dichloro Impurity; 1-(3,5- Dichlorophenyl)-2-[(1,1- dimethylethyl)amino]-1-propanone Hydrochloride; 2-(tert-Butylamino)-3′,5′- chloropropiophenone Hydrochloride; | 25MG,50MG | NA | 1346603-00-6 | 310.65 | C13H18Cl3NO | 2-(tert-Butylamino)-1-(3,5- dichlorophenyl)propan-1-one Hydrochloride; 5-Chloro Bupropion Hydrochloride; | Bupropion – Impurity J |
PA 02 60120 | 2-Amino-1-(3-Chlorophenyl)-1- Propanone Hydrochloride | IMP L | 2-Amino-1-(3- chlorophenyl)propan-1-one Hydrochloride; Bupropion Amine Hydrochloride; | 25MG,50MG | NA | 119802-69-6 | 220.1 | C9H11Cl2NO | NA | Bupropion – Impurity L |
PA 02 60510 | 2-tert-Butylamino-1-(4-chloro-phenyl)- propan-1-one Hydrochloride | IH | (2-(tert-Butylamino)-4’- chloropropiophenone Hydrochloride | 25MG,50MG | NA | 1049718-72-0 | 276.2 | C13H19Cl2NO | Bupropion Related Compound A; | Bupropion – In house impurity |
PA 02 60520 | 2-(tert-butylamino)-3′- bromopropiophenone hydrochloride | IH | 1-(3-Bromophenyl)-2-(tertbutylamino)propan-1-one Hydrochloride | 25MG,50MG | NA | 1049718-43-5 | 320.65 | C13H19BrClNO | Bupropion Related Compound B | Bupropion – In house impurity |
PA 02 60530 | 1-(3-chlorophenyl)-2-hydroxy-1- propanone | IH | 1-(3-chlorophenyl)-2-hydroxy-1- propanone | 25MG,50MG | na | 152943-33-4 | 184.62 | C9H9ClO2 | Bupropion Related Compound C | Bupropion – In house impurity |
PA 02 60540 | 2-(tert-butylamino)propiophe | IH | 2-(tert-butylamino)propiophenone hydrochloride; Deschloro Bupropion Hydrochloride; | 25MG,50MG | Refrigerator | 63199-74-6 | 241.76 | C13H20ClNO | Bupropion Related Compound D; | Bupropion – In house impurity |
PA 02 60550 | 1-(3-Chlorophenyl)-1,2-propanedione 2- Oxime | IH | 1-(m-Chlorophenyl)-1,2-propanedione 2- Oxime; 2 | 25MG,50MG | NA | 56472-71-0 | 197.62 | C9H8ClNO2 | NA | Bupropion – In house impurity |
PA 02 60560 | 1-(3-Chlorophenyl)-1-hydroxy-2- propanone | IH | 1-(m-Chlorophenyl)-1-hydroxy-2- propanone; | 25MG,50MG | NA | 857233-13-7 | 184.62 | C9H9ClO2 | Bupropion Related Compound F | Bupropion – In house impurity |
PA 02 60570 | 3-Chloropropiophenone | IH | 1-Phenyl-3-chloro-1-propanone; 3-chloro1-phenylpropan-1-one; | 25MG,50MG | Refrigerator | 936-59-4 | 168.62 | C9H9ClO | 2-Chloroethyl Phenyl Ketone; 3- Chloro-1-phenyl-1-propanone; NSC 227202; NSC 37238; βChloroethyl phenyl ketone; βChloropropiophenone; ωChloropropiophenone; | Bupropion – In house impurity |
PA 02 60580 | 3-Chlorobenzoic Acid | IH | Meta-chlorobenzoic Acid; mChlorobenzoic Acid; | 25MG,50MG | Refrigerator | 535-80-8 | 156.57 | C7H5ClO2 | NA | Bupropion – In house impurity |
PA 02 60590 | Bupropion Des-t-Butylamino Impurity | IH | 1-(3-Chlorophenyl)-1-propanone; 3- Chlorophenyl Ethyl Ketone; mChloropropiophenone; | 25MG,50MG | Refrigerator | 34841-35-5 | 168.62 | C9H9ClO | 3′-Chloropropiophenone; | Bupropion – In house impurity |
PA 02 60600 | 3’-Chloro-2-bromopropiophenone | IH | 2-Bromo-1-(3-chlorophenyl)-1- propanone; α-Bromo-3- chloropropiophenone; Bupropion 2- Bromo Impurity; 2-Bromo-1-(3- chlorophenyl)propan-1-one; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 34911-51-8 | 247.52 | C9H8BrClO | 2-Bromo-3′-chloropropiophenone; Bromochloropropiophenone; 2- Bromo-3-Chloropropiophenone; | Bupropion – In house impurity |
PA 02 60610 | Bupropion 3′,4′-Dichloro Impurity | IH | 1-(3,4-Dichlorophenyl)-2-[(1,1- dimethylethyl)amino]-1-propanone Hydrochloride; 4-Chloro Bupropion Hydrochloride; | 25MG,50MG | NA | 1346598-72-8 | *310.65 | C13H18Cl3NO | 2-(tert-Butylamino)-3′,4′- chloropropiophenone Hydrochloride; | Bupropion – In house impurity |
PA 02 60620 | (3S,5R,6R)-Bupropion Impurity | IH | (3S,5R,6R)-6-(3-Chlorophenyl)-6- hydroxy-5-methyl-3- thiomorpholine carboxylic Acid; R,S,S-Thiomorpholine Derivative | 25MG,50MG | NA | NA | 287.76 | C12H14ClNO3S | (3S,5R,6R)-6-(3- Chlorophenyl)-6-hydroxy-5- methylthiomorpholine-3- carboxylic Acid; | Bupropion – In house impurity |
PA 02 60630 | (3S,5S,6S)-Bupropion Impurity | IH | (3S,5S,6S)-6-(3-Chlorophenyl)-6- hydroxy-5-methyl-3- thiomorpholine carboxylic Acid; S,S,S-Thiomorpholine Derivative; | 25MG,50MG | NA | NA | 287.76 | C12H14ClNO3S | (3S,5R,6R)-6-(3- Chlorophenyl)-6-hydroxy-5- methylthiomorpholine-3- carboxylic Acid; | Bupropion – In house impurity |
PA 02 60640 | Threohydro Bupropion | IH | Threo Hydro Bupropion; (1R,2R)- 2-(tert-Butylamino)-1-(3- chlorophenyl)propan-1-ol; | 25MG,50MG | NA | NA | 241.76 | C13H20ClNO | NA | Bupropion – In house impurity |
PA 02 60650 | Erythro-Hydroxy Bupropion | IH | Erythro-Hydro Bupropion; (1R,2S)-2-(tert-Butylamino)-1-(3- chlorophenyl)propan-1-ol; (1R,2S)-erythro-Dihydro Bupropion | 25MG,50MG | NA | NA | 241.76 | C13H20ClNO | (αR) -3-Chloro- α- [(1S) – 1- [(1, 1- dimethylethyl) amino] ethyl] – benzenemethanol; (αR)-3- Chloro-α-[(1S)-1-[(1,1- dimethylethyl)amino]ethyl]- benzenemethanol; | Bupropion – In house impurity |
PA 02 61000 | Buspirone Hydrochloride | API | 8-[4-[4-(2-Pyrimidinyl)-1- piperazinyl]butyl]-8-azaspiro[4.5]decane7,9-dione; Ansial; | 25MG,50MG | Freezer | 33386-08-2 | 421.96 | C21H32ClN5O2 | Ansiced; Axoren; Bespar; Buspar; Narol; | Buspirone Hydrochloride – API |
PA 02 61010 | Di2-(Piperazin-1-yl)pyrimidine Dihydrochloride | IMP A | 1-(2-Pyrimidinyl)piperazine; 2- Piperazinopyrimidine; 4-(2- Pyrimidinyl)piperazine; | 25MG,50MG | Freezer, Under Inert Atmosphere | 20980-22-7 | 164.21 | C8H12N4 | CM 56324H; MJ 13653; N-2- Pyrimidinylpiperazine; PmP; 1-PP; | Buspirone – Impurity A |
PA 02 61020 | 8-(Pyrimidin-2-yl)-8-aza-5- azoniaspiro[4.5]decane Bromide | IMP B | 8-(Pyrimidin-2-yl)-5,8- diazaspiro[4.5]decan-5-ium Bromide; 8-(2-Pyrimidinyl)-8-aza5-azoniaspiro[4.5]decane Bromide | 25MG,50MG | NA | 81461-73-6 | 299.21 | C12H19BrN4 | NA | Buspirone – Impurity B |
PA 02 61060 | 4-[4-(Pyrimidin-2-yl)piperazin-1- yl]butyl [1-[2-oxo-2-[[4-[4-(pyrimidin2-yl)piperazin-1- yl]butyl]amino]ethyl]cyclopentyl]ac etate | IMP F | 4-(4-(Pyrimidin-2-yl)piperazin-1- yl)butyl 2-(1-(2-Oxo-2-((4-(4- (pyrimidin-2-yl)piperazin-1- yl)butyl)amino)ethyl)cyclopentyl)a cetate | 25MG,50MG | NA | NA | 621.82 | C33H51N9O3 | NA | Buspirone – Impurity F |
PA 02 61070 | 2,2’-(1,4-Piperazinediyl)bispyrimidine | IMP G | 2,2′-(Piperazine-1,4- diyl)dipyrimidine; 1,4-Bis(2- pyrimidinyl)piperazine; 1,4- Di(pyrimidin-2-yl)piperazine; | 25MG,50MG | NA | 84746-24-7 | 242.28 | C12H14N6 | NA | Buspirone – Impurity G |
PA 02 61110 | 8-Azpiro[4,5]decane-7,9-dione | IMP K | 8-Azaspiro[4.5]decane-7,9-dione; 1,1- Cyclopentanediacetimide; | 25MG,50MG | Refrigerator | 1075-89-4 | 167.21 | C9H13NO2 | 3-Spirocyclopentaneglutarimide; NSC 400092; | Buspirone – Impurity K |
PA 02 82000 | Busulfan | API | 1,4-Butanediol-dimethanesulfonate Esters; Busulphan; Butane-1,4-diyl dimethanesulfonate; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 55-98-1 | 246.3 | C6H14O6S2 | CB-2041; GT-41; Busulfex; Misulban; Myleran; | Busulfan – API |
PA 02 82510 | 4-Hydroxybutane-1-sulfonic Acid | IH | Busulfan Impurity 3; 1- Butanesulfonic Acid, 4-hydroxy-; | 25MG,50MG | NA | 26978-64-3 | 154.18 | C4H10O4S | NA | Busulfan – In house impurity |
PA 02 82520 | 4-Hydroxybutyl Methanesulfonate | IH | 1,4-butanediol, monomethanesulfonate; 4- Methanesulfonyloxybutanol; Busulfan Impurity 4; | 25MG,50MG | NA | 42729-95-3 | 168.21 | C5H12O4S | BRN 1858027; LS-45846; Methanesulfonic Acid 4- hydroxybutyl Ester; NSC67176; | Busulfan – In house impurity |
PA 02 82530 | 4-((Methylsulfonyl)oxy)butyl Acetate | IH | 1-Acetate 4-Methanesulfonate 1,4-Butanediol; 1-Mesyl-4-acetylbutanediol; MABD; | 25MG,50MG | NA | 19859-00-8 | 210.25 | C7H14O5S | NA | Busulfan – In house impurity |
PA 29 02000 | Butachlor | API | N-(Butoxymethyl)-2-chloro-N-(2,6- diethylphenyl)acetamide; 2- Chloro-2’,6’-diethyl-N- (butoxymethyl)acetanilide; 2’,6’- Diethyl-N-butoxymethyl-2- chloroacetanilide; | 25MG,50MG | Freezer, Under inert atmospher e | 23184-66-9 | 311.85 | C17H26ClNO2 | N-(Butoxymethyl)-2-chloro2’,6’-diethylacetanilide; | Butachlor – API |
PA 02 74000 | Butamirate Citrate | API | α-(Ethyl)benzeneacetic Acid 2-[2- (Diethylamino)ethoxy]ethyl Ester; 2- Hydroxy-1,2,3-propanetricarboxylate; | 25MG,50MG | Hygroscopic, Refrigerator, Under Inert Atmosphere | 18109-81-4 | 499.55 | C24H37NO10 | Abbott 36581; Acodeen; HH 197; Panatus; Sincodeen; Sincodin; Sincodix; Sinecod; Sinecond; | Butamirate Citrate – API |
PA 02 74510 | 2-Phenylbutyric Acid | IH | 2-Ethyl-2-phenylacetic Acid; αEthylbenzeneacetic Acid; (RS)-2- Phenylbutanoic Acid; | 25MG,50MG | Refrigerator | 90-27-7 | 164.2 | C10H12O2 | (+/-)-2-Phenylbutanoic Acid; αEthyl-α-toluic Acid; αEthylbenzeneacetic Acid; αEthylphenylacetic Acid; | Butamirate – In house impurity |
PA 02 74520 | N,N-Diethyl-2-phenylbutanamide | IH | 2-phenylbutanamide, N,N-diethyl- ; Butamirate Impurity 1; | 25MG,50MG | NA | 92321-53-4 | 219.32 | C14H21NO | NA | Butamirate – In house impurity |
PA 02 74530 | 2-(2-(Diethylamino)ethoxy)ethyl 2- phenylacetate | IH | α-Desethyl Butamirate; Benzeneacetic Acid 2-[2- (Diethylamino)ethoxy]ethyl Ester; Butamirate Impurity 2; | 25MG,50MG | NA | 47092-75-1 | 279.37 | C16H25NO3 | NA | Butamirate – In house impurity |
PA 02 74540 | (E)-2-(2- (Diethylamino)ethoxy)ethyl 2- phenylbut-2-enoate | IH | Phenylbut-2-enoate, (E)-2-(2- (diethylamino)ethoxy)ethyl 2-; | 25MG,50MG | NA | NA | 305.41 | C18H27NO3 | NA | Butamirate – In house impurity |
PA 02 78000 | Butenafine Hydrochloride | API | N-[[4-(1,1-Dimethylethyl)phenyl]methyl]- N-methyl-1-naphthalenemethanamine Hydrochloride; Mentax; Scorba; | 25MG,50MG | Refrigerator, Under Inert Atmosphere |
101827-46-7 | 353.93 | C23H28ClN | NA | Butenafine Hydrochloride – API |
PA 02 78510 | (R)-(+)-α-Methylbenzylamine | IH | (αR)-α-Methyl-benzenemethanamine; (+)- α-Phenethylamine; (R)-1-Amino-1- phenylethane; (R)-(+)-1- Phenylethylamine; | 25MG,50MG | Refrigerator | 3886-69-9 | 121.18 | C8H11N | NA | Butenafine Hydrochloride – In house impurity |
PA 02 62000 | Butetamate Citrate | API | Diethyl[2-[2-(2- Phenylbutyroyloxy)ethoxy]ethyl]ammoniu m dihydrogen Citrate; 2- (Diethylamino)ethyl 2-phenylbutanoate 2- hydroxypropane-1,2,3-tricarboxylate; | 25MG,50MG | NA | 13900-12-4 | 455.5 | C22H33NO9 | 2-(Diethylamino)ethyl 2- phenylbutanoate, 2- hydroxypropane-1,2,3-tricarboxylic Acid; | Butetamate Citrate – API |
PA 02 88000 | Butorphanol Tartrate | API | (4bS,8aS,9R)-11- (Cyclobutylmethyl)-6,7,8,8a,9,10- hexahydro-5H-9,4b- (epiminoethano)phenanthrene3,8a-diol Tartrate; | 25MG,50MG | NA | 58786-99-5 | 477.55 | C25H35NO8 | (4bS,8aS,9R)-11- (Cyclobutylmethyl)- 6,7,8,8a,9,10-hexahydro-5H9,4b- (epiminoethano)phenanthre ne-3,8a-diol (2S,3S)-2,3- dihydroxysuccinate; | Butorphanol Tartrate – API |
PA 02 63000 | Butyl Parahydroxybenzoate | API | 4-Hydroxybenzoic Acid Butyl Ester; 4- (Butoxycarbonyl)phenol; Butyl Hydroxybenzoate | 25MG,50MG | Refrigerator | 94-26-8 | 194.23 | C11H14O3 | 4-Hydroxybenzoic Acid Butyl Ester; 4-(Butoxycarbonyl)phenol; 4- Hydroxybenzoic Acid Butyl Ester; Aseptoform Butyl; Butoben; Butyl 4- Hydroxybenzoate; Butyl Butex; Butyl Tegosept; Butyl Chemosept; | Butyl Parahydroxybenzoat e – API |
PA 02 63010 | 4-Hydroxybenzhydrazide | IMP A | 4-Hydroxy-benzoic Acid Hydrazide; pHydroxy-benzoic Acid Hydrazide; pHydroxybenzohydrazide; pHydroxybenzoic Acid Hydrazide; pHydroxybenzoic Hydrazide; pHydroxybenzoyl Hydrazide; | 25MG,50MG | NA | 5351-23-5 | 152.15 | C7H8N2O2 | (4-Hydroxybenzoyl)hydrazine; (pHydroxybenzoyl)hydrazine; 4- Hydroxybenzhydrazide; 4- Hydroxybenzohydrazide; 4- Hydroxybenzoic Acid Hydrazide; 4- Hydroxybenzoyl Hydrazide; INHd | Butyl Parahydroxybenzoate – Impurity A |
PA 02 63020 | Methyl Paraben | IMP B | Methyl 4-Hydroxybenzoate; Methyl Parahydroxybenzoate; 4-Hydroxybenzoic Acid Methyl Ester; | 25MG,50MG | Refrigerator | 99-76-3 | 152.15 | C8H8O3 | 4-(Carbomethoxy)phenol; 4- (Methoxycarbonyl)phenol; 4- Hydroxybenzoic Acid Methyl Ester; 4-Hydroxymethyl Benzoate; Danisol M; E 218; Killitol; Maseptol; Mekkings M; Metaben; | Butyl Parahydroxybenzoate – Impurity B |
PA 02 63030 | Ethyl Paraben | IMP C | Ethyl 4-Hydroxybenzoate; Ethyl Parahydroxybenzoate; 4-hydroxybenzoic Acid Ethyl Ester; 4- (Ethoxycarbonyl)phenol; | 25MG,50MG | Refrigerator | 120-47-8 | 166.17 | C9H10O3 | 4-Carbethoxyphenol; 4- Hydroxybenzoic Acid Ethyl Ester; Aseptin A; Aseptoform E; Easeptol; Ethyl 4- Hydroxybenzoate; Ethyl Butex; Mekkings E; Mycocten; NSC | Butyl Parahydroxybenzoate – Impurity C |
PA 02 63040 | Propyl 4-Hydroxybenzoate | IMP D | Propyl Parahydroxybenzoate; | 25MG,50MG | NA | 94-13-3 | 128.21 | C8H16O | NA | Butyl Parahydroxybenz oate – Impurity D |
PA 02 63050 | Isobutyl Paraben | IMP E | 4-Hydroxybenzoic Acid 2-Methylpropyl Ester;2-Methylpropyl 4-Hydroxybenzoate ; Isobutyl Para-hydroxybenzoate; | 25MG,50MG | Refrigerator | *4247-02-3 | 194.23 | C11H14O3 | 4-Hydroxybenzoic Acid 2- Methylpropyl Ester; 2-Methylpropyl p-Hydroxybenzoate; Isobutyl 4- Hydroxybenzoate; Isobutyl pHydroxybenzoate; pHydroxybenzoic Acid Isobutyl | Butyl Parahydroxybenzoate – Impurity E |
PA 02 63510 | Benzyl Paraben | IH | 4-Hydroxybenzoic Acid Phenylmethyl Ester; 4-(Benzyloxycarbonyl)phenol; | 25MG,50MG | Refrigerator | 94-18-8 | 228.24 | C14H12O3 | 4-Hydroxybenzoic Acid Benzyl Ester; Benzyl 4-Hydroxybenzoate; Benzyl 4-Hydroxylbenzoate; Benzyl Parasept; Benzyl Tegosept; NSC 8080; Nipabenzyl; POB-BZ; Parosept; Solbrol Z; | Butyl Parahydroxybenzoate – In house impurity |
PA 02 63520 | Isopropyl Paraben | IH | 4-Hydroxybenzoic Acid 1- Methylethyl Ester; 4- Hydroxybenzoic Acid Isopropyl Ester; Isopropyl 4- Hydroxybenzoate; Isopropyl p | 25MG,50MG | Refrigerator | 4191-73-5 | 180.2 | C10H12O3 | p-Hydroxybenzoic Acid Isopropyl Ester; | Butyl Parahydroxybenz oate – In house impurity |
PA 02 64000 | Butylhydroxyanisole | API | (1,1-Dimethylethyl)-4-methoxyphenol; 2(3)-tert-Butyl-4-hydroxyanisole; Antioxyne B; BHA; BOA; Butylated Hydroxyanisole; Butylhydroxyanisole; 2- (tert-Butyl)-4-methoxyphenol; | 25MG,50MG | Refrigerator | 25013-16-5 | 180.24 | C11H16O2 | E 320; Embanox; Grindox BHA; Protex; Sustane 1F; Tenox BHA; tert-Butyl-4-hydroxyanisole; tertButyl-4-methoxyphenol; tert-Butylp-Hydroxyanisol; tert-Butyl-phydroxyanisole; tert | Butylhydroxyanisole – API |
PA 02 64010 | 1,4-Dihydroxybenzene | IMP A | 1,4-Benzenediol; 1,4-Benzoquinol; 1,4- Dihydroxybenzene; Dihydroquinone; | 25MG,50MG | Refrigerator | 123-31-9 | 110.11 | C6H6O2 | Eldopacque; Eldopaque; Eldopaque Forte; Eldoquin; 4- Hydroxyphenol; p-Hydroxyphenol; p-Phenylenediol; p-Quinol; | Butylhydroxyanisole – Impurity A |
PA 02 64510 | 2-(1,1-Dimethylethyl)-1,4- dihydroxybenzene | IH | tert-Butylhydroquinone; 2-(1,1- Dimethylethyl)hydroquinone; 2-(tertButyl)-p-hydroquinone; 2-tButylhydroquinone; 2-tert-Butyl-1,4- benzenediol; 2-tert-Butyl-1,4- dihydroxybenzene; 2-tert-Butyl-1,4- hydroquinone; 2-tert-Butylhydroquinone; | 25MG,50MG | NA | 1948-33-0 | 166.99 | C10H14O2 | Banox 20BA; Grindox 204; Grindox 450; Keniox 20; MC-TB 20; MTBHQ; Mono-tertbutylhydroquinone; Monotertiarybutylhydroquinone; NSC 4972; TBHQ; Tenox 20; Tenox TBHQ; t-Butylhydroquinone; tButylhydroquinone; tert-Butyl-1,4- | Butylhydroxyanisole – In house impurity |
PA 02 65000 | Butylhydroxytoluene | API | 2,6-Bis(1,1-dimethylethyl)-4- methylphenol; 2,6-Di(tertbutyl)hydroxytoluene; 2,6-Di-tert-butyl-4- hydroxytoluene; | 25MG,50MG | NA | 128-37-0 | 220.35 | C15H24O | 2,6-Ditertbutyl Paracresol; 4- Methyl-2,6-bis(1,1- dimethylethyl)phenol; Advastab 401; Dalpac; Deenax; Impruvol; Ionol; Topanol; | Butylhydroxytoluene – API |
PA 02 71000 | Butyrophenone | API | 1-Phenyl-1-butanone; 1-Benzoylpropane; 1-Phenyl-1-butanone; Butanophenone; NSC 8463; | 25MG,50MG | Refrigerator | 495-40-9 | 148.2 | C10H12O | Phenyl n-Propyl Ketone; Phenyl Propyl Ketone; Propyl Phenyl Ketone; n-Butyrophenone; nPropyl Phenyl Ketone; | Butyrophenone – API |
PA 03 01000 | Cabazitaxe | API | (αR,βS)-β-[[(1,1- Dimethylethoxy)carbonyl]amino]-αhydroxybenzenepropanoic Acid (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS )-12b-(Acetyloxy)-12-(benzoyloxy)- 2a,3,4,4a,5,6,9,10,11,12,12a,12bdodecahydro-11-hydroxy-4,6-dimethoxy4a,8,13,13-tetramethyl-5-oxo-7,11- methano-1H-cyclodeca[3,4]benz[1,2- b]oxet-9-yl Ester; | 25MG,50MG | Freezer | 183133-96-2 | 835.93 | C45H57NO14 | TXD 258; XRP 6258; β-[[(1,1- Dimethylethoxy)carbonyl]amino]-αhydroxybenzenepropanoic Acid [2aR- [2aα,4β,4aβ,6β,9α(αR*,βS*),11α,1 2α,12aα,12bα]]-12b-(Acetyloxy)-12- (benzoyloxy)- 2a,3,4,4a,5,6,9,10,11,12,12a,12bdodecahydro-11-hydroxy-4,6- dimethoxy-4a,8,13,13-tetramethyl | Cabazitaxel – API |
PA 03 01510 | De-boc Cabazitaxel | IH | (2aR,4S,4aS,6R,9S,11S,12S,12a R,12bS)-12b-acetoxy-9-(((2R,3S)- 3-amino-2-hydroxy-3- phenylpropanoyl)oxy)-11-hydroxy4,6-dimethoxy-4a,8,13,13- tetramethyl-5-oxo2a,3,4,4a,5,6,9,10,11,12,12a,12bdodecahydro-1H-7,11- | 25MG,50MG | NA | 1638286-64-2 | 735.82 | C40H49NO12 | NA | Cabazitaxel – In house impurity |
PA 03 01520 | 10-Deacetyl-7,10-dimethoxyBaccatin III | IH | (2aR,4S,4aS,6R,9S,11S,12S,12a R,12bS)-12b-(Acetyloxy)-12- (benzoyloxy)- 1,2a,3,4,4a,6,9,10,11,12,12a,12bdodecahydro-9,11-dihydroxy-4,6- dimethoxy-4a,8,13,13-tetramethyl7,11-methano-5H | 25MG,50MG | NA | 183133-94-0 | 572.64 | C31H40O10 | [2aR- (2aα,4β,4aβ,6β,9α,11α,12α, 12aα,12bα)]-12b-(Acetyloxy)- 12-(benzoyloxy)- 1,2a,3,4,4a,6,9,10,11,12,12 a,12b-dodecahydro-9,11- dihydroxy-4,6-dimethoxy | Cabazitaxel – In house impurity |
PA 03 01530 | Cabazitaxel N-formyl Impurity | IH | N-De-boc-N-formyl Cabazitaxel; (2aR,4S,4aS,6R,9S,11S,12S,12a R,12bS)-12b-acetoxy-9-(((2R,3S)- 3-Formamido-2-hydroxy-3- phenylpropanoyl)oxy)-11-hydroxy4,6-dimethoxy-4a,8,13,13- tetramethyl-5-oxo2a,3,4,4a,5,6,9,10,11,12,12a,12bdodecahydro-1H-7,11 | 25MG,50MG | NA | NA | 763.83 | C41H49NO13 | NA | Cabazitaxel – In house impurity |
PA 03 01540 | 10-Deacetyl-7,10,13-trimethyl Baccatin III | IH | Trimethoxy 10-DAB III; (2aR,4S,4aS,6R,9S,11S,12S,12b S)-12b-Acetoxy-11-hydroxy-4,6,9- trimethoxy-4a,8,13,13-tetramethyl5-oxo2a,3,4,4a,5,6,9,10,11,12,12a, 12b-dodecahydro-1H-7,11- methanocyclodeca[3,4]benzo[1,2- b]oxet-12-yl Benzoate; | 25MG,50MG | NA | 1584118-06-8 | 586.67 | C32H42O10 | NA | Cabazitaxel – In house impurity |
PA 03 01550 | (2’S,3’R)-Cabazitaxel | IH | (2aR,4S,4aS,6R,9S,11S,12S,12a R,12bS)-12b-Acetoxy-9-(((2S,3R)- 3-((tert-butoxycarbonyl)amino)-2- hydroxy-3-phenylpropanoyl)oxy)- 11-hydroxy-4,6-dimethoxy4a,8,13,13-tetramethyl-5-oxo2a,3,4,4a,5,6,9,10,11,12,12a, 12b-dodecahydro-1H-7,11- methanocyclodeca[3,4]benzo[1,2- b]oxet-12-yl Benzoate; | 25MG,50MG | NA | 1714967-27-7 | 835.93 | C45H57NO14 | NA | Cabazitaxel – In house impurity |
PA 03 01560 | Cabazitaxel Di Boc Impurity | IH | Benzenepropanoic Acid, β- [bis[(1,1-dimethylethoxy) carbonyl]amino]- α-hydroxy-, (2aR,4S,4aS,6R,9S,11S,12S, 12aR,12bS)-12b-(acetyloxy)-12- (benzoyloxy)- 2a,3,4,4a,5,6,9 ,10,11,12,12a,12b-dodecahydro11-hydroxy-4,6-dimethoxy4a,8,13,13-tetramethyl-5-oxo7,11-methano-1H-cyclodeca[3,4] | 25MG,50MG | NA | NA | 938.06 | C50H67NO16 | NA | Cabazitaxel – In house impurity |
PA 03 01570 | Oxazolidine Cabazitaxel | IH | (4S,5R)-2,2-Dimethyl-4-phenyl3,5-oxazolidinedicarboxylic Acid 5- [(2aR,4S,4aS,6R,9S,11S,12S,12 aR,12bS)-12b-(acetyloxy)-12- (benzoyloxy)- 2a,3,4,4a,5,6,9,10,11,12,12a,12bdodecahydro-11-hydroxy-4,6- dimethoxy-4a,8,13,13-tetramethyl5-oxo-7,11-methano-1H | 25MG,50MG | NA | 1373171-12-0 | 876 | C48H61NO14 | (4S,5R)-5- ((2aR,4S,4aS,6R,9S,11S,12 S,12bS)-12b-Acetoxy-12- (benzoyloxy)-11-hydroxy-4,6- dimethoxy-4a,8,13,13- tetramethyl-5-oxo2a,3,4,4a,5,6,9,10,11,12,12 a,12b-dodecahydro-1H-7,11- methanocyclodeca[3,4]benz | Cabazitaxel – In house impurity |
PA 03 01580 | 2-Debenzoyl-2-tigloyl 10-Deacetyl Baccatin III | IH | (2E)-2-Methyl-2-butenoic Acid (2aR,4S,4aS,6R,9S,11S,12S,12a R,12bS)-12b-(acetyloxy)- 2a,3,4,4a,5,6,9,10,11,12,12a,12bdodecahydro-4,6,9,11- tetrahydroxy-4a,8,13,13- tetramethyl-5-oxo-7,11-methano1H-cyclodeca[3,4]benz[1,2-b]oxet12-yl Ester; 2-Debenzoyl-2-tigloy | 25MG,50MG | Amber Vial, Freezer | 171926-87-7 | 522.58 | C27H38O10 | NA | Cabazitaxel – In house impurity |
PA 03 01590 | (4S,5S)-3-(tert-Butoxycarbonyl)-2- (4-methoxyphenyl)-4- phenyloxazolidine-5-carboxylic Acid | IH | Cabazitaxel Impurity 20; | 25MG,50MG | NA | NA | 399.44 | C22H25NO6 | NA | Cabazitaxel – In house impurity |
PA 03 01600 | (4R,5R)-3-(tert-Butoxycarbonyl)-2- (4-methoxyphenyl)-4- phenyloxazolidine-5-carboxylic Acid | IH | Cabazitaxel Impurity 22; | 25MG,50MG | NA | NA | 399.44 | C22H25NO6 | NA | Cabazitaxel – In house impurity |
PA 03 02000 | Cabergoline | API | (8β)-N-[3-(Dimethylamino)propyl]-N- [(ethylamino)carbonyl]-6-(2-propen-1-yl)- ergoline-8-carboxamide; FCE-21336; Cabaser; Dostinex; | 25MG,50MG | Freezer, Under Inert Atmosphere | 81409-90-7 | 451.6 | C26H37N5O2 | NA | Cabergoline – API |
PA 03 02510 | Cabergoline N-Oxide | IH | (3-{{[6aR,9R,10aR)-7-Allyl4,6,6a,7,8,9,10,10a-octahydroindolo[4,3- fg]quinolin9yl]carbonyl}[ethylamino)carbonyl]amino} propyl)(dimethyl)ammoniumolate; | 25MG,50MG | Freezer | NA | 467.6 | C26H37N5O3 | NA | Cabergoline – In house impurity |
PA 03 02520 | (6aR,9R,10aR)-N-[3- (dimethylamino)propyl]-7-(prop-2-enyl)- 4,6,6a,7,8,9,10,10a-octahydroindolo[4,3- fg]quinoline-9-carboxamide | IMP D | Desethylcarbamoyl Cabergoline; N-[3- (Dimethylamino)propyl]-6-(2-propen-1-yl)- (8β)-ergoline-8-carboxamide; | 25MG,50MG | Freezer | 85329-86-8 | 380.53 | C23H32N4O | (5R,8R,10R)-6-Allyl-N-[3- (dimethylamino)propyl]ergoline-8- carboxamide; FCE 21590; Cabergoline Related Compound D; | Cabergoline – Impurity D |
PA 03 02530 | Dimethyl Cabergoline | IH | (8β)-N-[3-(Dimethylamino)propyl]-N-[(Nmethyl-N-ethylamino)carbonyl]-6-(2- propen-1-yl)-1-methylergoline-8- carboxamide; | 25MG,50MG | Freezer | NA | 479.66 | C28H41N5O2 | NA | Cabergoline – In house impurity |
PA 03 02540 | (6aR,9R,10aR)-7-(Prop-2-enyl)- 4,6,6a,7,8,9,10,10a-octahydroindolo[4,3- fg]quinoline-9-carboxylic Acid | IMP A | 6-Allyl-8β-carboxyergoline; (8β)-6-(2- Propen-1-yl)-ergoline-8-carboxylic Acid; 6-(2-Propenyl)dihydrolysergic Acid; FCE 21589; | 25MG,50MG | Amber Vial, Freezer | 81409-74-7 | 296.36 | C18H20N2O2 | Cabergoline Related Compound A; | Cabergoline – Impurity A |
PA 03 02550 | (6aR,9R,10aR)-N9-[3- (Dimethylamino)propyl]-N4-ethyl-7-(prop-2- enyl)-6a,7,8,9,10,10a-hexahydroindolo[4,3- fg]quinoline-4,9(6H)-dicarboxamide | IMP B | N8-Desethylcarbamoyl-N1- ethylcarbamoyl Cabergoline; (8β)-N8-[3- (Dimethylamino)propyl]-N1-ethyl-6-(2- propen-1-yl)-ergoline-1,8-dicarboxamide; (8β)-N8-[3-(Dimethylamino)propyl]-N1- ethyl-6-(2-propenyl)-ergoline-1,8- dicarboxamide; | 25MG,50MG | NA | 166533-36-4 | 451.6 | C26H37N5O2 | (6aR,9R,10aR)-N9.-[3- (Dimethylamino)propyl]-N4.-ethyl-7- (prop-2-enyl)6a,7,8,9,10,10ahexahydroindolo[4,3-fg]quinoline4,9(6H)-dicarbox-amide; Cabergoline Related Compound B; | Cabergoline – Impurity B |
PA 03 02560 | (6aR,9R,10aR)-N9-[3- (Dimethylamino)propyl]-N4-ethyl-N9-(ethylcarbamoyl)-7-(prop2-enyl)- 6a,7,8,9,10,10a-hexahydroindolo[4,3- fg]quinoline-4,9(6H)-dicarboxamide | IMP C | N1-Ethylcarbamoyl Cabergoline; (8β)-N8- [3-(Dimethylamino)propyl]-N1-ethyl-N8- [(ethylamino)carbonyl]-6-(2-propen-1-yl)- ergoline-1,8-dicarboxamide; (8β)-N8-[3- (dimethylamino)propyl]-N1-ethyl-N8- [(ethylamino)carbonyl]-6-(2-propenyl)- ergoline-1,8-dicarboxamide | 25MG,50MG | NA | 126554-50-5 | 522.68 | C29H42N6O3 | (6aR,9R,10aR)-N9-[3- (Dimethylamino)propyl]-N4-ethylN9-(ethylcarbamoyl)-7-(prop-2- enyl)-6a,7,8,9,10,10ahexahydroindolo[4,3-fg]quinoline4,9(6H)-dicarboxamide; Cabergoline Related Compound C; | Cabergoline – Impurity C |
PA 30 62000 | Cabozantinib | API | N-(4-((6,7-dimethoxyquinolin-4- yl)oxy)phenyl)-N-(4- fluorophenyl)cyclopropane-1,1- dicarboxamide | 25MG,50MG | NA | 849217-68-1 | 501.51 | C28H24FN3O5 | NA | Cabozantinib – API |
PA 03 03000 | Caffeic Acid | API | 3-(3,4-Dihydroxyphenyl)-2-propenoic Acid; 3,4-Dihydroxycinnamic Acid; | 25MG,50MG | Refrigerator, Under Inert Atmosphere | 331-39-5 | 180.16 | C9H8O4 | 3,4-Dihydroxybenzeneacrylic Acid; 3-(3,4-Dihydroxyphenyl)-2- propenoic Acid; 4-(2- Carboxyethenyl)-1,2- dihydroxybenzene; NSC 57197; NSC 623438; | Caffeic Acid – API |
PA 03 03510 | 3-O-Acetyl Caffeic Acid Methyl Ester 4-O- (Tri-O-acetyl-β-D-glucuronic Acid Methyl Ester) | IH | Methyl {2’-Acetoxy-4’-[3’’-(methylprop2’’(Z)-enoate)]phenyl 2,3,4-Tri-O-acetyl-βD-glucopyranoside}uronate; | 25MG,50MG | Refrigerator | NA | 552.48 | C25H28O14 | NA | Caffeic Acid – In house impurity |
PA 03 03520 | 4-O-Acetyl Caffeic Acid Methyl Ester 3-O- (Tri-O-acetyl-β-D-glucuronic Acid Methyl Ester) | IH | 3-(4-Hydroxy-3-methoxyphenyl)-2- propenoic Acid 2-Phenylethyl Ester; | 25MG,50MG | NA | NA | 298.33 | C18H18O4 | 2-Phenylethyl Ferulate; Ferulic Acid Phenethyl Ester; NSC 666255; NSC 671193; Phenethyl Ferulate; Phenethyl 3- Methylcaffeate; | Caffeic Acid – In house impurity |
PA 03 03530 | 4-O-Benzyl-caffeic Acid Methyl Ester | IH | 3-(4-Benzyloxy-4-hydroxyphenyl)-2- propenoic Acid Methyl Ester; | 25MG,50MG | NA | NA | 284.31 | C17H16O4 | 3-[3-Hydroxy-4- (phenylmethoxy)phenyl]-2- propenoic Acid Methyl Ester | Caffeic Acid – In house impurity |
PA 03 03540 | 4-O-Benzyl-caffeic Acid 3-O-Sulfate Methyl Ester Pyridinium Salt | IH | 3-(4-Benzyloxy-4-O-sulfatephenyl)-2- propenoic Acid Methyl Ester Pyridinium Salt; | 25MG,50MG | NA | NA | 443.47 | C22H21NO7S | NA | Caffeic Acid – In house impurity |
PA 03 03550 | 3-[3,4-Bis(acetyloxy)phenyl]-2-propenoic Acid | IH | (E)-Caffeic Acid Diacetate; | 25MG,50MG | NA | 88623-81-8 | 264.23 | C13H12O6 | NA | Caffeic Acid – In house impurity |
PA 03 03560 | Caffeic Acid-13C3 | IH | 3-(3,4-Dihydroxyphenyl)-2-propenoic Acid-13C3; 3,4-Dihydroxycinnamic Acid13C3; | 25MG,50MG | Freezer, Under Inert Atmosphere | 1185245-82-2 | 183.14 | C613C3H8O4 | 4-(2-Carboxyethenyl)-1,2- dihydroxybenzene-13C3; NSC 57197-13C3 | Caffeic Acid – In house impurity |
PA 03 03570 | Caffeic Acid Benzyl Ester | IH | 3-(3,4-Dihydroxyphenyl)-2-propenoic Acid Phenylmethyl Ester; 3-(3,4- Dihydroxyphenyl)-2-propenoic Acid Benzyl Ester; | 25MG,50MG | NA | 107843-77-6 | 270.28 | C16H14O4 | Benzyl Caffeate; NSC 666590; | Caffeic Acid – In house impurity |
PA 03 03580 | Caffeic Acid Dimethyl Ether Phenethyl Ester | IH | 3-(3,4-Dimethoxyphenyl)-2-propenoic Acid 2-Phenylethyl Ester; NSC 666253; Phenethyl 3,4- Dimethoxyphenylcinnamate; Phenethyl Dimethyl Caffeate; | 25MG,50MG | Freezer | 145551-14-0 | 97-98° | C19H20O4 | NA | Caffeic Acid – In house impurity |
PA 03 03590 | Caffeic Acid 3-β-D-Glucuronide | IH | 5-[(1E)-2-Carboxyethenyl]-2- hydroxyphenyl β-DGlucopyranosiduronic Acid; | 25MG,50MG | Freezer, Under Inert Atmosphere | 1093679-73-2 | 356.28 | C15H16O10 | NA | Caffeic Acid – In house impurity |
PA 03 03600 | Caffeic Acid 4-β-D-Glucuronide | IH | 4-[(1E)-2-Carboxyethenyl]-2- hydroxyphenyl β-DGlucopyranosiduronic Acid; | 25MG,50MG | Freezer, Under Inert Atmosphere | 1093679-71-0 | 356.28 | C15H16O10 | NA | Caffeic Acid – In house impurity |
PA 03 03610 | Caffeic Acid 3-β-D-Glucoside | IH | 3-[3-(β-D-Glucopyranosyloxy)-4- hydroxyphenyl]-2-propenoic Acid; | 25MG,50MG | NA | 24959-81-7 | 342.3 | C15H18O9 | 3-(β-D-Glucopyranosyloxy)-4- hydroxycinnamic Acid; |
Caffeic Acid – In house impurity |
PA 03 03620 | Caffeic Acid 3-Methyl Phenethyl Ester | IH | 3-(4-Hydroxy-3-methoxyphenyl)-2- propenoic Acid 2-Phenylethyl Ester; | 25MG,50MG | NA | 71835-85-3 | 298.33 | C18H18O4 | 2-Phenylethyl Ferulate; Ferulic Acid Phenethyl Ester; NSC 666255; NSC 671193; Phenethyl Ferulate; Phenethyl 3- Methylcaffeate; | Caffeic Acid – In house impurity |
PA 03 03630 | Caffeic Acid Methyl Ester | IH | (E)-3-(3,4-Dihydroxyphenyl)propenoic Acid Methyl Ester; | 25MG,50MG | Refrigerator | 67667-67-8 | 194.18 | C10H10O4 | NA | Caffeic Acid – In house impurity |
PA 03 03640 | Caffeic Acid Methyl Ester 3,4-Di-O-(tri-Oacetyl-β-D-glucuronic Acid Methyl Ester) | IH | Caffeic Acid Methyl Ester 3,4-Di-O-(tri-Oacetyl-β-D-glucuronic Acid Methyl Ester) | 25MG,50MG | NA | NA | NA | C36H42O22 | NA | Caffeic Acid – In house impurity |
PA 03 03650 | Caffeic Acid Phenethyl Ester | IH | 3-(3,4-Dihydroxyphenyl)-2-propenoic Acid 2-Phenylethyl Ester; CAPE; Phenethyl Caffeate; | 25MG,50MG | NA | 104594-70-9 | 284.31 | C17H16O4 | NA | Caffeic Acid – In house impurity |
PA 03 03660 | Dihydrocaffeic Acid | IH | 3,4-Dihydroxy-β-phenylpropionic Acid; 3,4-Dihydroxybenzenepropionic Acid; 3,4- Dihydroxyhydrocinnamic Acid; 3,4- Dihydroxyphenylpropionic Acid; | 25MG,50MG | Amber Vial, Refrigerator | 1078-61-1 | 182.17 | C9H10O4 | 3-(3,4-Dihydroxyphenyl)propanoic Acid; 3-(3,4- Dihydroxyphenyl)propionic Acid; Hydrocaffeic Acid; NSC 407275; NSC 624007; 3,4- | Caffeic Acid – In house impurity |
PA 03 03670 | Dihydro Caffeic Acid 3-O-β-D-Glucuronide | IH | 5-(2-Carboxyethyl)-2-hydroxyphenyl β-DGlucopyranosiduronic Acid; | 25MG,50MG | Freezer, Under Inert Atmosphere | 1187945-71-6 | 358.3 | C15H18O10 | NA | Caffeic Acid – In house impurity |
PA 03 03680 | Dihydro Caffeic Acid 3-O-Sulfate Sodium Salt | IH | 4-Hydroxy-3- (sulfooxy)benzenepropanoic Acid Sodium Salt; | 25MG,50MG | Freezer, Under Inert Atmosphere | 1187945-70-5 | 306.2 | C9H8Na2O7S | NA | Caffeic Acid – In house impurity |
PA 03 03690 | Ferulic Acid 4-O-β-D-Glucuronide | IH | 4-(2-Carboxyethenyl)-2-methoxyphenyl βD-Glucopyranosiduronic Acid; | 25MG,50MG | NA | 86321-24-6 | 370.31 | C16H18O10 | NA | Caffeic Acid – In house impurity |
PA 03 03700 | Methyl 3-(3’,4’- Dimethoxyphenyl)propenoate | IH | Methyl 3,4-Dimethoxycinnamate; 3-(3,4- Dimethoxyphenyl)-2-propenoic Acid Methyl Ester; | 25MG,50MG | Refrigerator | 5396-64-5 | 222.24 | C12H14O4 | 3,4-O-Dimethylcaffeic Acid Methyl Ester; NSC 4331; | Caffeic Acid – In house impurity |
PA 03 04000 | Caffeine | API | 3,7-Dihydro-1,3,7-trimethyl-1H-purine2,6-dione; 1,3,7-Trimethylxanthine; SK 65 Compound; Shape Plus; Stay Alert; Stim; Synalgos; Thein; Theine; Tri-Aqua; Wigraine; Phensal; Refresh’n; | 25MG,50MG | Refrigerator | 58-08-2 | 194.19 | C8H10N4O2 | 7-Methyltheophylline; Alert-Pep; Cafalgine; Cafeina; Caffedrine; Caffein; Cafipel; DHCplus; Dasin; Diurex; Durvitan; Guaranine; Hycomine; Koffein; |