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Impurities

Sr No. Name of Impurity/Ref Standards CAS No. Enquiry
A Apixaban
1 Apixaban Reference Standard 503612-47-3
2 1-(4-iodophenyl)-3-morpholino-5,6-dihydropyridin-2(1H)-one 473927-69-4
3 Ethyl chloro[(4-methoxyphenyl)hydrazono]acetate 27143-07-3
4 Morpholine 110-91-8
5 Valerolactum 675-20-7
6 Ethyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate 503614-91-3
7 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 503614-91-3
B Anagliptin hydrochloride
1 2-methylpyrazolo[1,5-a]pyrimidine-6-carboxylic acid 739364-95-5
2 2-(Boc-oxyimino)-2-phenylacetonitrile 58632-95-4
3 (2S)-1-(Chloroacetyl)-2-pyrrolidinecarbonitrile 207557-35-5
4 2-Amino-2-methylpropanenitrile 19355-69-2
C Azilsartan Kmedoxomil
1 Azilsartan medoxomil 863031-21-4
2 Methyl 1-((2'-cyano-[1,1'-biphenyl]-4-yl)methyl)-2-ethoxy-1Hbenzo[d]imidazole-7-carboxylate 139481-44-0
3 3-[(4-{2-[(Z)-N'-hydroxycarbamimidoyl]phenyl}phenyl)methyl]-2-oxo-2,3-dihydro-1H-1,3-benzodiazole-4-carboxylic acid 1821386-21-3
4 methyl 3-((2'-cyanobiphenyl-4-yl)methyl)-2-oxo-2,3-dihydro-1Hbenzo[d]imidazole-4-carboxylate(Impurity I) 139481-33-7
5 methyl 1-((2'-carbamoyl-[1,1'-biphenyl]-4-yl)methyl)-2-ethoxy-1H-benzo[d]imidazole-7-carboxylate(Impurity A) 147404-76-0
6 (Z)-2-ethoxy-1-((2'-(N'-hydroxycarbamimidoyl)-[1,1'-biphenyl]-4-yl)methyl)-1Hbenzo[d]imidazole-7-carboxylic acid(Impurity C) 1397836-49-5
7 methyl 2-ethoxy-1-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1'-biphenyl]-4-yl)methyl)-1Hbenzo[d]imidazole-7-carboxylate(Azilsartan methyl ester) 147403-52-9
8 2-oxo-3-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1'-biphenyl]-4-yl)methyl)-2,3-dihydro-1H-benzo[d]imidazole-4-carboxylicacid(Impurity K) 1442400-68-1
9 methyl (Z)-2-ethoxy-1-((2'-(N'-hydroxycarbamimidoyl)-[1,1'-biphenyl]-4-yl)methyl)-1Hbenzo[d]imidazole-7-carboxylate(Impurity 2) 147403-65-4
10 2-Ethoxy-1-[[2’-(4,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylic Acid(Azilsartan Acid) 147403-03-0
11 methyl 1-((2'-carbamoyl-[1,1'-biphenyl]-4-yl)methyl)-2-ethoxy-1H-benzo[d]imidazole-7-carboxylate(Impurity A) 1474404-76-0
12 1-((2'-cyano-[1,1'-biphenyl]-4-yl)methyl)-2-ethoxy-1Hbenzo[d]imidazole-7-carboxylic acid(Impurity M) 632322-61-3
13 (Z)-2-ethoxy-1-((2'-(N'-hydroxycarbamimidoyl)-[1,1'-biphenyl]-4-yl)methyl)-1Hbenzo[d]imidazole-7-carboxylic acid(Impurity C) 1397836-49-5
14 methyl (Z)-3-((2'-(N'-hydroxycarbamimidoyl)-[1,1'-biphenyl]-4-yl)methyl)-2-oxo-2,3-dihydro-1H-benzo[d]imidazole-4-carboxylate(Impurity H) 1499167-72-4
15 methyl 2-oxo-3-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1'-biphenyl]-4-yl)methyl)-2,3-dihydro-1H-benzo[d]imidazole-4-carboxylate(Impurity J) 1403474-78-1