A N-Nitroso bis(2-cloroetil)amina (CAS 67856-68-2), fórmula molecular C4H8Cl2N2O e massa molar 171,02 g/mol, é uma nitrosamina alquílica diclorada com elevada reatividade eletrofílica e comportamento alquilante. Essa impureza pode surgir por nitrosação de intermediários derivados de bis(2-cloroetil)amina ou por contaminação relacionada ao processo durante a síntese de agentes cloroetilantes. Como impureza genotóxica reconhecida, enquadra-se nos princípios de controle baseado em risco descritos em ICH M7. Sua determinação normalmente requer técnicas altamente seletivas, como LC-MS/MS ou GC-MS, frequentemente com diluição isotópica, devido à ocorrência em nível traço e aos limites regulatórios muito baixos.
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