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.
La N-Nitroso epinefrina, CAS 3006789-99-4, es un derivado nitrosamina de la epinefrina con fórmula molecular C9H12N2O4 y peso molecular de 212,20 g/mol. Como impureza N-nitroso de una catecolamina, puede formarse bajo condiciones nitrosantes en presencia de precursores amínicos o mediante rutas de nitrosación oxidativa en matrices complejas de sustancias activas. El motivo nitrosamina la sitúa en la clase de impurezas genotóxicas contempladas por ICH M7. Su determinación a niveles traza suele requerir LC-MS/MS, con confirmación por MS de alta resolución, y un diseño metodológico que considere adsorción, baja volatilidad e interferencias por supresión iónica.
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