Bis(2-aminoethyl)(nitroso)amine (CAS 741659-46-1) es una impureza nitrosamina crítica observada en síntesis de compuestos que contienen grupos amino | caracterizada por alta polaridad y tendencia a formación de sales. Desde el punto de vista analítico requiere métodos sensibles | como LC-MS/MS o GC-MS con derivatización | para detección en niveles trazas | con límites de cuantificación en el rango ng/g. La impureza muestra reactividad con agentes oxidantes y estabilidad limitada en condiciones ácidas | por lo que el control en procesos incluye condiciones de reducción | eliminación mediante etapas de purificación y especificaciones acordes a guías ICH M7 para impurezas genotóxicas. Validación rigurosa y muestreo representativo son imprescindibles.
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