26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N‑Nitrosodiethylamine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Beschreibung
N-Nitrosodiethylamin (NDEA), CAS 55-18-5, ist ein niedrigmolekulares Nitrosamin mit der Formel C4H10N2O und einer Molmasse von 102,14 g/mol. Es entsteht typischerweise durch Nitrosierung sekundärer Amine während der Synthese, durch Lösungsmittelverunreinigungen oder über oxidative Abbaupfade und wird als stark genotoxische Verunreinigung eingestuft. Im regulatorischen Kontext wird NDEA nach den Grundsätzen von ICH M7 und den geltenden Nitrosamin-Anforderungen bewertet, da ein kanzerogenes Risiko besteht. Für den Nachweis und die Quantifizierung sind hochselektive Verfahren wie GC-MS, GC-MS/MS oder LC-MS/MS erforderlich, häufig mit isotopenmarkierten internen Standards zur Bestimmung im sub-ppb-Bereich.
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