26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N‑Nitrosodiethylamine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Descrição
A N-Nitrosodietilamina (NDEA), CAS 55-18-5, é uma nitrosamina de baixo peso molecular, com fórmula C4H10N2O e massa molecular de 102,14 g/mol. Sua formação está frequentemente associada à nitrosação de aminas secundárias durante a síntese, à contaminação por solventes ou a vias de degradação oxidativa, sendo classificada como impureza genotóxica relevante. No contexto regulatório farmacêutico, NDEA é avaliada segundo os princípios da ICH M7 e das exigências aplicáveis para nitrosaminas, devido ao seu potencial carcinogênico. A detecção e a quantificação normalmente exigem técnicas altamente seletivas, como GC-MS, GC-MS/MS ou LC-MS/MS, muitas vezes com padrões internos isotopicamente marcados para quantificação em nível sub-ppb.
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