N-Nitroso Dabigatran Etexilate
| CAS No. | : |
| Mol F. | : C34H40N8O6 |
| Mol W. | : 656.73 |
| Cat No. | : SA446101 |
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Description
| Product Name | N-Nitroso Dabigatran Etexilate |
| Synonyms | Ethyl (Z)-3-(2-(((4-(N’-((hexyloxy)carbonyl)carbamimidoyl)phenyl)(nitroso)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate |
| Related API | Nitrosamine |
| Category | Impurities |
N-Nitroso Dabigatran Etexilate product with CAS: is also known as Ethyl (Z)-3-(2-(((4-(N’-((hexyloxy)carbonyl)carbamimidoyl)phenyl)(nitroso)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. It is used in Nitrosamine impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, Ethyl (Z)-3-(2-(((4-(N’-((hexyloxy)carbonyl)carbamimidoyl)phenyl)(nitroso)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.
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