N-Nitroso Vildagliptin L-Prolinamida, também designado Vildagliptin N-Nitroso-L-Prolinamida, é uma impureza relacionada a nitrosaminas, com CAS 79108-51-3, fórmula molecular C5H9N3O2 e massa molecular de 143,1 g/mol. Como derivado N-nitroso de um motivo prolinamida, está associado a processos de nitrosação que podem ocorrer quando intermediários contendo amina são expostos a agentes nitrosantes durante a síntese ou o armazenamento. Essas espécies são avaliadas segundo a ICH M7 devido ao potencial mutagênico e genotóxico. A quantificação em nível de traço normalmente requer LC-MS/MS, frequentemente complementada por LC-MS de alta resolução ou GC-MS após derivatização apropriada, para assegurar detecção em níveis muito baixos e confirmação estrutural em matrizes farmacêuticas complexas.
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