Dinitroso Palbociclib, também designado Palbociclib Nitroso Impurity 2, é uma impureza de processo derivada de nitroso associada ao arcabouço de palbociclibe e estruturalmente compatível com funcionalidade do tipo nitrosamina. Com fórmula molecular C24H27N9O4 e massa molecular de 505.05 g/mol, trata-se de um produto definido de nitrosação e oxidação que pode surgir durante a síntese ou sob condições nitrosantes aplicadas a intermediários contendo aminas. Essas espécies são avaliadas sob a orientação ICH M7 devido ao potencial risco mutagênico. A determinação em nível traço normalmente requer LC-MS/MS, LC-MS de alta resolução e, quando aplicável, confirmação por GC-MS.
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