A study on structural characterization of degradation products of cangrelor using LC/QTOF/MS/MS and NMR.

J Pharm Biomed Anal

Centre for Chemical Science & Technology, Institute of Science & Technology, JNTUH, Kukatpally, Hyderabad, 500 085, India.

Published: June 2019

A complete degradation study was performed on cangrelor drug substance as per the ICH guidelines. The study reveals that a total of six degradation products (DP-1 to DP-6) were found and out of these, three unknown degradation products (DP-1, DP-5 and DP-6) were not reported in the literature. Based on the degradation study, the drug substance cangrelor was found to be sensitive towards acidic, basic and oxidative conditions. Besides, it was stable under thermal and photolytic stress conditions. The degradation products were characterized by using advanced LC/QTOF and MS/MS analysis. Further, the structures were characterized by NMR studies. The identified degradation products of cangrelor are valuable for cangrelor manufacturing process and quality control.

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http://dx.doi.org/10.1016/j.jpba.2019.03.031DOI Listing

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