26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N,N′‑Di‑nitrosopiperazine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
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Description
N-Nitroso piperazine dimer, also designated N,N'-dinitrosopiperazine or 1,4-dinitrosopiperazine (CAS 140-79-4), is a symmetrical nitrosamine impurity of formula C4H8N4O2 and molecular weight 144.13 g/mol. The compound is associated with nitrosation of piperazine-containing intermediates or residues under acidic, nitrite-rich conditions and is of regulatory concern because nitrosamines are frequently treated as potentially genotoxic impurities under ICH M7 and related risk assessments. Owing to low expected concentrations and matrix complexity, determination typically relies on LC-MS/MS or GC-MS with selective ion monitoring and confirmatory fragmentation.
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