Buspirone EP Impurity M, also designated Buspirone Bromobutyl Analog, CAS 80827-62-9, is a brominated process-related impurity with molecular formula C13H20BrNO2 and molecular weight 302.21 g/mol. Structurally, it represents an alkylated analog of the buspirone scaffold in which a bromobutyl substituent replaces the corresponding side chain motif, consistent with formation during synthetic intermediate handling or halogenation side reactions. Owing to its close physicochemical similarity to the parent API, trace-level resolution typically requires LC-MS/MS, high-resolution LC-MS, and orthogonal HPLC methods with selective UV or MS detection. Its qualification is relevant within impurity profiling frameworks and ICH M7 risk assessment when synthetic origin is investigated.
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