This impurity is related to N-Nitroso Dabigatran Impurity 54 is provided with comprehensive characterization data in accordance with regulatory guidelines. It is suitable for use in analytical method development, method validation (AMV), Quality Control (QC) applications for Abbreviated New Drug Applications (ANDA) and commercial production of Asenapine.
N-Nitroso Dabigatran Impurity 54 is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:ethyl 3-(2-(((4-(N-(3-(2-(((4-(N-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoyl)carbamimidoyl)phenyl)(nitroso)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoateCountry of Origin: India Product Category: Impurity Reference StandardAPI NAME: Dabigatran Molecular Formula: C59H63N15O8
Molecular Weight: 1110.227
Storage: Store in a cool, dry place.