Valsartan Nitroso VAM-II é uma impureza N-nitroso associada ao valsartan, pertencente à classe das nitrosaminas e compatível estruturalmente com um derivado N-nitrosado formado sob condições nitrosantes durante síntese, processamento ou armazenamento. Com fórmula molecular C20H21N3O3 e massa molecular de 351.40 g/mol, enquadra-se no perfil de contaminante traço com potencial genotóxico, sujeito a controlo rigoroso segundo ICH M7 e às avaliações regulatórias atuais de nitrosaminas. A sua deteção e quantificação exigem tipicamente LC-MS/MS de elevada seletividade, frequentemente complementada por espectrometria de massa de alta resolução, uma vez que a deteção por UV não oferece sensibilidade nem especificidade suficientes. O analito integra o perfil de impurezas do valsartan.
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