N-Nitroso Aceclofenac es el derivado N-nitrosamínico de aceclofenaco, una impureza estructuralmente definida de interés toxicológico que puede generarse por nitrosación del nitrógeno anilídico bajo condiciones ácidas, en presencia de nitrito o durante etapas de proceso. Con fórmula molecular C16H12Cl2N2O5 y peso molecular de 383.18 g/mol, presenta el motivo N-nitroso característico de compuestos con posible genotoxicidad y evaluación según ICH M7 y marcos regulatorios sobre nitrosaminas. Su cuantificación a nivel traza suele requerir LC-MS/MS selectiva o LC-MS de alta resolución, con confirmación por GC-MS cuando la volatilidad y el comportamiento cromatográfico lo permiten, ya que los métodos UV carecen de especificidad suficiente.
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