Nilotinib Impurity 18 (CAS 2469039-94-7) é uma impureza identificada no perfil analítico de nilotinibe | relevante para controle de qualidade e avaliação de estabilidade. Caracteriza-se por massa e fragmentação específicas determinadas por LC-MS e HRMS | e por sinais confirmatórios em RMN 1H/13C. A quantificação por HPLC com detector UV permite monitoramento em rotina | suportando limites de especificação compatíveis com ICH Q3A/Q3B. Avaliações de formação durante síntese | condições de degradação forçada e estudos de toxicidade ajudam a definir critérios analíticos e aceitabilidade | garantindo rastreabilidade e conformidade regulatória.
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