Sr. Applications Chemist, Thermo Fisher Scientific
BIOGRAPHY
JUN 23, 2021 1:40 PM BST
Determination of Dimethylamine and Nitrite in Pharmaceuticals by Ion Chromatography to Assess the Likelihood of Nitrosamine Formation
Presented at:
Thermo Fisher Scientific 2021 Global IC Symposium
Speaker
Abstract
Since July 2018 several drugs have been recalled due to contamination with N-nitrosodimethylamine (NDMA), a probable human carcinogen. Dimethylamine (DMA) and nitrite are precursors in the formation of NDMA. Ion chromatography (IC) methods were developed for the determination of these two precursors in drug substances and drug products. . The methods for DMA should be applicable to other amines to assess the likelihood of the formation of other nitrosamines in pharmaceutical products.
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