Low-Level Determination of Mutagenic Nitrosamine Impurities in Drug Substances by LC–MS/MS - IDEX Health & ScienceIDEX Health & Science

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    Low-Level Determination of Mutagenic Nitrosamine Impurities in Drug Substances by LC–MS/MS

    Article obtained from LCGC Liquid Chromatography (LC/HPLC) RSS Feed.

    This article discusses the development of a series of applications that will allow for the determination of a number of nitrosamines that have been identified by the FDA as genotoxins to monitor, initially showing how to perform a separation of these compounds from the API and then looking at how MS can be applied to the analysis to ensure that the required detection limits can be reached.

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    Jul, 12 2021 |

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