Dinitroso Palbociclib, también denominado Palbociclib Nitroso Impurity 2, es una impureza de proceso derivada de nitroso asociada al andamiaje de palbociclib y estructuralmente compatible con una funcionalidad de tipo nitrosamina. Con fórmula molecular C24H27N9O4 y peso molecular de 505.05 g/mol, corresponde a un producto definido de nitrosación y oxidación que puede formarse durante la síntesis o bajo condiciones nitrosantes sobre intermedios que contienen aminas. Estas especies se consideran en el marco de ICH M7 por su posible relevancia mutagénica. Su determinación a nivel de traza suele requerir LC-MS/MS, LC-MS de alta resolución y, cuando procede, confirmación mediante GC-MS.
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