Amino Pyridilamide Edoxaban Impurity

Amino Pyridilamide Edoxaban Impurity product with CAS: 482375-18-8 is also known as N1-((1S,2R,4S)-2-amino-4-(dimethylcarbamoyl)cyclohexyl)-N2-(5-chloropyridin-2-yl)oxalamide; . This product can be used as a working standard or secondary reference standard (additional internal validation as per respective FDA regulations/guidelines may require). Amino pyridilamide is used in Edoxaban impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines during commercial production of Edoxaban and its related formulations. Moreover, N1-((1S,2R,4S)-2-amino-4-(dimethylcarbamoyl)cyclohexyl)-N2-(5-chloropyridin-2-yl)oxalamide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation. Please also find out other impurities of Edoxaban developed in our R&D.