100 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N‑Nitrosophenylephrine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Descrição
A N-nitroso fenilefrina (CAS 78658-64-7) é uma impureza do tipo nitrosamina associada à função amina secundária de estruturas derivadas de fenilefrina, podendo formar-se por nitrosação, estresse oxidativo ou contaminação do processo por fontes de nitrito. Com fórmula C9H12N2O3 e massa molecular de 196.2 g/mol, apresenta um grupo N-nitroso ligado a um esqueleto aminoálcool quiral, uma alerta estrutural relevante na avaliação de impurezas genotóxicas segundo ICH M7. A quantificação em nível de traço normalmente requer LC-MS/MS altamente seletiva, muitas vezes complementada por MS de alta resolução ou GC-MS após derivatização.
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