N-Nitroso Abemaciclib, también designado Abemaciclib Nitroso Impurity 1, es una impureza de proceso relacionada con las nitrosaminas y derivada de la conversión nitrosante del andamiaje de abemaciclib que contiene piperazina. Con fórmula molecular C27H31F2N9O y peso molecular de 535.59 g/mol, presenta una función N-nitroso definida, de relevancia regulatoria porque las nitrosaminas se evalúan habitualmente conforme a ICH M7 por su posible riesgo mutagénico y genotóxico. La confirmación estructural y la cuantificación a nivel traza suelen requerir LC-MS/MS, LC-HRMS y, cuando procede para especies volátiles o derivatizadas, GC-MS. Su formación puede asociarse con nitrito, impurezas de reactivos o nitrosación inducida por el proceso.
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