Journal
CHEMICAL & PHARMACEUTICAL BULLETIN
Volume 68, Issue 4, Pages 392-397Publisher
PHARMACEUTICAL SOC JAPAN
DOI: 10.1248/cpb.c20-00032
Keywords
forced degradation; chemical stability; structure elucidation; impurity; epimerization
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The degradation pathway of a taxane derivative and anticancer agent, DS80100717, was investigated. Several degradants were generated under acidic, basic, and oxidative stress conditions in solution. The chemical structures of eight degradants of DS80100717 were elucidated using MS and NMR. The major degradant of the DS80100717 drug substance derived by heating in solid-state was the N-oxide form via oxidation and C2'-epimer of the side chain via acid hydrolysis. We proposed previously unreported degradation pathways of DS80100717 with taxane derivatives such as paclitaxel, docetaxel, and cabazitaxel.
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