In situ identification and quantification of genotoxic sulfonyl chloride impurity in topiramate (Topamax tablets) via LC-MS/MS

This study reports a sensitive and selective method developed and validated for the detection of process-related genotoxic impurity (PGI) formed in situ during the synthesis of topiramate API. The method utilizes benzyl amine as a derivatizing agent to enhance sensitivity. of impurity. Chromatograph...

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Bibliographic Details
Main Authors: Hitesh Thumbar, Jayesh Dhalani, Hetal Patel, Bhavin Dhaduk
Format: Article
Language:English
Published: Elsevier 2025-12-01
Series:MethodsX
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2215016125002870
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