Vildagliptin N-Nitroso-L-Proline Methyl Ester (CAS 35909-01-4) é uma impureza nitrosada relevante em controles de qualidade de substâncias ativas | caracterizada como um éster N-nitroso derivado da L-prolina. Esta impureza é gerada por reações de nitrosação durante síntese ou armazenamento e pertence à classe de nitrosaminas que exige monitorização analítica rigorosa devido a preocupações toxicológicas. A detecção e quantificação geralmente utilizam técnicas sensíveis como LC-MS/MS e GC-MS com validação de método para níveis em traço. O controle desta impureza segue princípios de Boas Práticas de Fabricação e estratégias de redução de risco para garantir conformidade regulatória.
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