Leflunomide Impurity 3 | identificado pelo CAS 62004-05-1 e também referido como 3-Trifluoro Isomer | é uma impureza estrutural relevante no desenvolvimento e controlo de qualidade da leflunomida. Caracteriza-se por uma substituição trifluoro no anel aromático que pode afetar perfil de potência e segurança do composto ativo. A sua deteção e quantificação exigem métodos analíticos sensíveis como HPLC acoplado a LC-MS e validação conforme diretivas ICH Q3A. Estratégias de mitigação incluem otimização de etapa de síntese | purificação e limites de especificação específicos. Fornecemos dados de caracterização | espectros de massa e orientações para controlo analítico.
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