Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs)

已完结 10 由 H 发布于 2026/8/27 9:44:06

DOI:10.1021/acs.oprd.3c00084
作者：Ian W. Ashworth,?Alexander Blanazs*,?Jonathan J. Byrne,?Olivier Dirat,?Jared W. Fennell,?Nadine Kuhl,?Stuart L. Wells and Matthew P. Whiting,?
文献类型：期刊论文
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American Chemical Society (ACS)

Abstract：N-Nitrosamine risk assessment of pharmaceuticals has moved from an initial focus on the potential presence of known small-molecule N-nitrosamines such as N-nitrosodimethylamine (NDMA) and N-

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