Impureza 130 do Brexpiprazol é uma impureza relacionada ao processo de síntese | identificada por um perfil cromatográfico e espectrométrico distinto que requer controle analítico específico. Detectável por HPLC-UV e LC-MS | com confirmação estrutural por RMN | apresenta comportamento de retenção e polaridade que a diferenciam do princípio ativo. Deve ser quantificada e limitada conforme diretrizes ICH Q3A e Q3B para minimizar riscos à qualidade e à segurança do produto. Medidas de controle incluem otimização das condições reacionais | etapas de purificação dirigidas e ensaios de liberação de lote para garantir conformidade com especificações.
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