Buspirone EP Impurity M, também denominada Buspirone Bromobutyl Analog, CAS 80827-62-9, é uma impureza bromada relacionada ao processo, com fórmula molecular C13H20BrNO2 e massa molecular de 302,21 g/mol. Estruturalmente, corresponde a um análogo alquilado do esqueleto da buspirona, no qual o motivo lateral correspondente é substituído por um substituinte bromobutilo, coerente com formação durante o manuseio de intermediários sintéticos ou por reações secundárias de halogenação. Devido à semelhança fisicoquímica com o fármaco, a detecção em traços normalmente requer LC-MS/MS, LC-MS de alta resolução e métodos ortogonais de HPLC com detecção UV seletiva ou por MS. Sua avaliação é relevante em perfis de impurezas e no contexto de ICH M7.
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