100 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-epinephrine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
N-Nitroso Epinephrine, CAS 3006789-99-4, é um derivado nitrosamínico da epinefrina com fórmula molecular C9H12N2O4 e massa molecular de 212,20 g/mol. Como impureza N-nitroso de uma catecolamina, pode formar-se sob condições nitrosantes na presença de precursores amínicos secundários ou por vias de nitrosação oxidativa em matrizes complexas de substâncias ativas. A função nitrosamina enquadra essa espécie na classe de impurezas genotóxicas avaliadas sob ICH M7. A determinação em nível traço normalmente requer LC-MS/MS, com confirmação por espectrometria de alta resolução, e o desenho metodológico deve considerar adsorção, baixa volatilidade e supressão iônica dependente da matriz.
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