Acalabrutinib M5 Metabolite

CAS No. : NA
Mol F. : C36H40N10O8S
Mol W. : 772.83
Cat No. : SA46304


Product NameAcalabrutinib M5 Metabolite

Related APIAcalabrutinib

Acalabrutinib M5 Metabolite product with CAS: NA is also known as N5-((R)-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-yl)thio)-1-(carboxy(methyl)amino)-1-oxopropan-2-yl)-L-glutamine; . 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 M5 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, N5-((R)-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-yl)thio)-1-(carboxy(methyl)amino)-1-oxopropan-2-yl)-L-glutamine 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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Certificate of Analysis (CoA) and Characterization Data:

All products are provided with a certificate of analysis (CoA) along with the characterization data like 1H-NMR, MASS, HPLC Purity, MSDS, etc. (whatever relevant and possible). Moreover, additional data like 13C-NMR, 13C-DEPT NMR, GC, GC-MS, IC, Potency, TGA, etc. will be provided on request (extra charges may apply). 

This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. This product provided by SynThink is generally used for Abbreviated New Drug Application (ANDA) filing to FDA, toxicity study of respective drug formulation, Quality Control (QC) and analytical studies during commercial production of the API]. Please also find out process impurities, degradation impurities, potential impurities of related api/drug developed by our R&D.

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