96 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N‑Nitrosodimethylamine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
N-Nitroso-dimethylamine (NDMA), CAS 62-75-9, is a low-molecular-weight nitrosamine impurity of molecular formula C2H6N2O and molecular weight 74.08 g/mol. It is formed through nitrosation of dimethylamine under acidic or oxidative conditions and may arise as a synthesis-related contaminant or from degradation of amine-containing materials. NDMA is classified as a potent genotoxic carcinogen and is controlled within the regulatory framework for mutagenic impurities, including ICH M7. Trace-level determination commonly requires highly selective methods such as LC-MS/MS or GC-MS, often with headspace or SPE enrichment due to volatility and low ppb occurrence.
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