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 |