26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-desmethyl-pheniramine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Description
N-Nitroso N-desmethyl Pheniramine is a nitrosamine impurity related to the pheniramine scaffold, arising plausibly from nitrosative conversion of the corresponding secondary amine during manufacture or storage under nitrite-containing conditions. With molecular formula C15H17N3O and molecular weight 255.31 g/mol, it presents structural features associated with class concern for mutagenic and potentially carcinogenic risk, warranting assessment under ICH M7 principles and nitrosamine-specific regulatory expectations. Trace-level determination generally requires orthogonal, high-sensitivity methods such as LC-MS/MS and, where volatility permits, GC-MS, often with selective ion monitoring or tandem fragmentation to resolve it from matrix interferences.
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