La N-Nitroso bis(2-cloroetil)amina (CAS 67856-68-2), fórmula molecular C4H8Cl2N2O y peso molecular 171,02 g/mol, es una nitrosamina alquílica diclorada con marcada reactividad electrofílica y capacidad alquilante. Esta impureza puede originarse por nitrosación de intermediarios derivados de bis(2-cloroetil)amina o por contaminación relacionada con el proceso durante la síntesis de agentes cloroetilantes. Como impureza genotóxica reconocida, se sitúa dentro del marco de control basado en el riesgo de ICH M7. Su determinación suele exigir técnicas altamente selectivas como LC-MS/MS o GC-MS, a menudo con dilución isotópica por su presencia a nivel traza y los límites regulatorios muy bajos.
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