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.