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This document describes a study on the forced degradation of bambuterol hydrochloride according to ICH guidelines. Twelve degradation products were identified under various stress conditions like acid/base hydrolysis, oxidation, and photolysis. Major degradation products were isolated by semi-preparative HPLC and characterized using NMR and LCMS-QTOF techniques. The fragmentation patterns of bambuterol and its degradation products were also investigated by LCMS-MS to understand the degradation pathways and

Author

Yuliet Susanto

Language

EN