文章基本信息

标题：Degradation Pathway of a Taxane Derivative DS80100717 Drug Substance and Drug Product
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作者：Kousuke Tamura ; Makoto Ono ; Takefumi Kawabe 等
期刊名称：Chemical and Pharmaceutical Bulletin
印刷版ISSN：0009-2363
电子版ISSN：1347-5223
出版年度：2020
卷号：68
期号：4
页码：392-397
DOI：10.1248/cpb.c20-00032
出版社：The Pharmaceutical Society of Japan
摘要：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..
关键词：forced degradation;chemical stability;structure elucidation;impurity;epimerization