N-Nitrosomethylethanolamine (CAS 26921-68-6) es una impureza nitrosamínica crítica en matrices farmacéuticas y químicas por su genotoxicidad y potencial carcinógeno. Se origina por nitrosación de aminas secundarias en presencia de nitritos y grupos hidroxietilo durante síntesis o almacenamiento | y su naturaleza polar y estabilidad relativa dificultan su remoción. La detección y cuantificación requieren técnicas analíticas sensibles como cromatografía líquida acoplada a espectrometría de masas de alta resolución y cromatografía de gases con detección selectiva | además de protocolos de muestreo y límites de aceptación ajustados a requisitos regulatorios. Su monitoreo continuo es esencial para garantizar la seguridad y conformidad del producto.
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