Description

Acalabrutinib M10 Metabolite product with CAS: NA is also known as (R)-2-Amino-3-((E)-4-((S)-2-(8-amino-1-(4-(pyridin-2-ylcarbamoyl)phenyl)imidazo[1,5-a]pyrazin-3-yl)pyrrolidin-1-yl)-4-oxobut-2-en-2-ylthio)propanoic acid; . This product can be used as a working standard or secondary reference standard (additional internal validation as per respective FDA regulations/guidelines may require). Acalabrutinib M10 Metabolite is used in Acalabrutinib impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines during commercial production of Acalabrutinib and its related formulations. Moreover, (R)-2-Amino-3-((E)-4-((S)-2-(8-amino-1-(4-(pyridin-2-ylcarbamoyl)phenyl)imidazo[1,5-a]pyrazin-3-yl)pyrrolidin-1-yl)-4-oxobut-2-en-2-ylthio)propanoic acid 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 Acalabrutinib developed in our R&D.

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