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.
Descripción
La N-nitroso fenilefrina (CAS 78658-64-7) es una impureza de tipo nitrosamina asociada con la función amina secundaria de estructuras derivadas de fenilefrina, que puede formarse por nitrosación, estrés oxidativo o contaminación del proceso con fuentes de nitrito. Con fórmula C9H12N2O3 y peso molecular de 196.2 g/mol, presenta un grupo N-nitroso unido a un esqueleto aminoalcohólico quiral, una alerta estructural relevante para la evaluación de impurezas genotóxicas según ICH M7. Su determinación a nivel traza suele requerir LC-MS/MS altamente selectiva, a menudo complementada con MS de alta resolución o GC-MS tras derivatización.
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