N-Nitroso Dabigatran Etexilate

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.