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-Nitrosodimethylamin (NDMA), CAS 62-75-9, ist ein niedermolekulares Nitrosamin mit der Summenformel C2H6N2O und einer Molekülmasse von 74,08 g/mol. Die Verbindung entsteht durch Nitrosierung von Dimethylamin unter sauren oder oxidativen Bedingungen und kann als prozessbedingte Verunreinigung oder durch Abbau aminhaltiger Materialien auftreten. NDMA gilt als stark genotoxisches Karzinogen und unterliegt dem regulatorischen Rahmen für mutagene Verunreinigungen, einschließlich ICH M7. Die Spurendetektion erfordert in der Regel hochselektive Verfahren wie LC-MS/MS oder GC-MS, häufig mit Headspace- oder SPE-Anreicherung aufgrund von Flüchtigkeit und Konzentrationen im ppb-Bereich.
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