S.No Impurity Code Structure Chemical  Name Remarks
1 DAB Impurity -A   3-(2-((4-Amidinophenylamino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoic acid Process related , and
Metabolite
2 DAB Impurity -B Ethyl 3-(2-((4-amidinophenylamino) methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate Process related,
Degradation
(oxidative)
and
Metabolite
3 DAB Impurity -C Ethyl 3-[[[2-[[[4-[[[(ethylloxy)carbonyl]amino] iminomethyl]phenyl]amino] methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino] propanoate Process related
4 DAB Impurity -D 3-(2-(((4-(N-((hexyloxy)carbonyl)carbamimidoyl) phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoic acid Process related , degradation
(acid,base)
and
Metabolite
5 DAB Impurity -E Hexyl ((4-(((5-((3amino-3oxopropyl)(pyridin-2yl) carbamoyl)-1methyl-1H-benzo[d]idazol2yl)methyl) amino)henyl)(imino)methyl)carbamate Process related
6 DAB Impurity -G Ethyl 2-(((4-(N-((hexyloxy)carbonyl) carbamimidoyl)phenyl)amino)methyl) -1-methyl-1H-benzo[d]imidazole-5-carboxylate .
Process related
7 DAB Impurity -H 2-(((4-(N-((hexyloxy) carbonyl)carbamimidoyl) phenyl)amino)methyl) -1-methyl-1H-benzo[d]imidazole-5-carboxylic acid .
Process related
8 DAB Impurity -J Ethyl 3-(2-(((4-(((hexyloxy)carbonyl)carbamoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate Process related
and
Degradation
(Temp.&
humidity)
9 DAB Impurity -K Ethyl 3-[[[2-[[[4-[[[(pentyloxy) carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoate Process related
Table 1: Origin and pathway of DBA impurities