Development of a derivatization RP-HPLC method for determination of sulfuryl chloride in chlorosulfonic acid for gefapixant citrate manufacture

Control of process impurities during manufacturing of drug substance is critical to ensure quality and process robustness. During commercial process development for the gefapixant citrate drug substance, several process impurities were found to derive from sulfuryl chloride, an impurity in the raw m...

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Published inJournal of pharmaceutical and biomedical analysis Vol. 215; p. 114752
Main Authors Huang, Chunli, Song, Siqing, Liu, Wenjun, Parganiha, Priya, Zhuang, Ping, Lohani, Sachin, Alwedi, Embarek, Ren, Hong, Bishara, Daniel, Chang, Hsieh Yao D.
Format Journal Article
LanguageEnglish
Published England Elsevier B.V 05.06.2022
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