26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N‑Nitrosodiethanolamine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
N-Nitrosodiethanolamin (NDIEA), CAS 1116-54-7, ist eine niedermolekulare Nitrosamin-Verunreinigung mit der Summenformel C4H10N2O3 und einer Molekülmasse von 134.13 g/mol. Die Verbindung entspricht der nitrosativen Umwandlung von Diethanolamin unter Bedingungen mit Nitrit, saurem Milieu oder prozessbedingter Kontamination. Als Vertreter der N-Nitrosamin-Klasse wird sie in aktuellen regulatorischen Bewertungsansätzen, einschließlich ICH-M7, als potenziell genotoxische Verunreinigung behandelt. Für die Bestimmung sind in der Regel hochselektive LC-MS/MS- oder GC-MS-Verfahren erforderlich, häufig unter Einsatz isotopenmarkierter interner Standards, da Spurenmengen durch Flüchtigkeit, Matrixeffekte und Hintergrundkontamination erschwert werden.
References
Fan, T. Y., Goff, U., Song, L., Fine, D. H., Arsenault, G. P., & Biemann, K. (1977). N-Nitrosodiethanolamine in cosmetics, lotions and shampoos. Food and Cosmetics Toxicology, 15(5), 423?430. https://doi.org/10.1016/s0015-6264(77)80007-2 ?
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