N-Nitroso Aceclofenac é o derivado N-nitrosamínico do aceclofenaco, uma impureza estruturalmente definida de relevância toxicológica que pode formar-se por nitrosação do nitrogênio anilídico em condições ácidas, na presença de nitrito ou sob condições de processo. Com fórmula molecular C16H12Cl2N2O5 e massa molar de 383.18 g/mol, contém o motivo N-nitroso característico de compostos associados a potencial genotoxicidade e à avaliação segundo ICH M7 e estruturas regulatórias para nitrosaminas. A determinação em nível de traço normalmente exige LC-MS/MS seletivo ou LC-MS de alta resolução, com confirmação por GC-MS quando volatilidade e comportamento cromatográfico são adequados, pois métodos UV carecem de especificidade suficiente.
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