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.
Description
N-Nitroso Phenylephrine (CAS 78658-64-7) is a nitrosamine impurity associated with the secondary amine functionality of phenylephrine-derived structures, arising during nitrosation, oxidative stress, or process contamination from nitrite sources. With formula C9H12N2O3 and molecular weight 196.2 g/mol, it contains an N-nitroso group linked to a chiral aminoalcohol scaffold, a structural alert relevant to genotoxic impurity assessment under ICH M7. Trace determination typically requires highly selective LC-MS/MS, often complemented by high-resolution MS or GC-MS after derivatization, due to low expected concentration and matrix interference.
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