Impurity Name | Impurity structure | Remarks |
Impurity-B Chemical Name: 3-[[2-[(4-(N-Hydroxycarbaimidoyl)- phenyl amino) methyl]-1-methyl-1H- benzoimidazole-5-carbonyl] pyridine-2-yl-amino]-propionicacid ethyl ester |
| Process related Impurity. |
Impurity-C Chemical Name: ethyl 3-(2-(((4-carbamimidoylphenyl) amino)methyl)-1-methyl-N- (pyridin-2-yl)-1H- benzo[d]imidazole-5- carboxamido)propanoate |
| Dabigatran Ethyl Ester, Process related and degradant impurity (oxidation) |
Impurity-E Chemical Name: 3-(2-(((4-(N-((hexyloxy)carbonyl) carbamimidoyl)phenyl)amino) methyl)-1-methyl-N- (pyridin-2-yl)-1H- benzo[d]imidazole-5- carboxamido)propanoic acid |
| Dabigatran Etexilate acid. Degradant impurity (acid/Base) and Metabolite. |
Impurity-H Chemical Name: (Z)-isopropyl-3-(2-(((4-(N’-((hexyloxy)carbonyl)carbamimidoyl)phenyl) amino)methyl)1-methyl-N- (pyridine-2-yl)-1H-benzo[d] imidazole-5-carboxamido)propionate |
| Process related Impurity. |