N-Nitroso Desethyl Abemaciclib es una impureza de tipo nitrosamina asociada al andamiaje de abemaciclib, cuya formación es verosímil bajo condiciones nitrosantes sobre el precursor amínico desetilado durante la síntesis o el almacenamiento. Con fórmula molecular C25H27F2N9O y masa molecular de 507.54 g/mol, incorpora el motivo N-nitroso, relevante desde el punto de vista toxicológico porque las nitrosaminas relacionadas se gestionan habitualmente como impurezas potencialmente genotóxicas conforme a los principios de ICH M7. Su caracterización a nivel de trazas suele requerir LC-MS/MS con confirmación de masa exacta, a menudo complementada por LC-HRMS y, cuando la volatilidad lo permite, GC-MS. La asignación estructural debe considerar tautomería e ionización.
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