Risk characterization of N-nitrosodimethylamine in pharmaceuticals

Since 2018, N-nitrosodimethylamine (NDMA) has been a reported contaminant in numerous pharmaceutical products. To guide the pharmaceutical industry, FDA identified an acceptable intake (AI) of 96 ng/day NDMA. The approach assumed a linear extrapolation from the Carcinogenic Potency Database (CPDB) h...

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Veröffentlicht in:	Food and chemical toxicology 2024-04, Vol.186, p.114498-114498, Article 114498
Hauptverfasser:	Paustenbach, D.J., Brown, S.E., Heywood, J.J., Donnell, M.T., Eaton, D.L.
Format:	Artikel
Sprache:	eng
Schlagworte:	Mutagenic impurities N-nitrosodimethylamine NDMA Nitrosamines Pharmaceuticals Risk assessment
Online-Zugang:	Volltext
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