A impureza N-Nitroso Nilotinib Impurity 2 é uma nitrosamina relacionada ao nilotinibe que requer monitorização rigorosa devido ao seu potencial genotóxico. O perfil analítico exige identificação e quantificação por técnicas sensíveis como LC-MS/MS e GC-MS | com validação de método para limites de detecção abaixo de níveis aceitáveis segundo diretrizes ICH M7 e órgãos regulatórios. Estudos de estabilidade e investigação de vias de formação são essenciais para estratégias de controle durante síntese e armazenamento. A caracterização inclui pureza | massa molecular e espectrometria | e os dados suportam medidas de mitigação | especificação de limites e avaliação de risco toxicológico.
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