La impureza N-Nitroso Diamyl Amine (N-nitrosodiamilamina | CAS 13256-06-9) es un nitrosamino que puede formarse por nitrosación de aminas secundarias en procesos sintéticos y en matrices farmacéuticas. Su presencia exige monitoreo riguroso debido a su potencial genotóxico y a límites regulatorios exigentes. Se recomienda detección y cuantificación mediante técnicas sensibles como GC-MS o LC-MS/MS tras extracción en fase sólida y validación según guías ICH. Controles de proceso | eliminación de fuentes de nitrosantes y validación de métodos analíticos son críticos para minimizar riesgo y asegurar conformidad con especificaciones de impurezas relacionadas.
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