N-Nitroso N-etil N-propilamina (NEPA) (CAS 25413-61-0) es una impureza nitrosamínica de bajo peso molecular que exige control riguroso en materias primas y productos farmacéuticos. Identificada también como N-Nitroso N-Ethyl N-Propyl Amine | propylamine N-ethyl-N-nitroso | propylethylnitrosamine o ethyl(nitroso)propylamine | manifiesta alta reactividad y potencial genotóxico asociado al grupo nitroso. Se recomienda monitoreo por cromatografía líquida de alta resolución acoplada a espectrometría de masas para límites en ppb | estudios de estabilidad bajo condiciones ácidas y oxidantes | y métodos analíticos validados que respalden control de calidad y cumplimiento regulatorio.
Referencias
NISHIE, K. ?Phototoxicity and Differential Hepatotoxicity as Biological Indicators of Nitrosamine Activity.? Toxicology and Applied Pharmacology, vol. 23, no. 4, Dec. 1972, pp. 680?91, https://doi.org/10.1016/0041-008x(72)90108-1.?
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