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Collaborative analysis of complex nitrosamines

pdf fileOliveira A; Martins-Avila C; Ponting DJ; Tennant RE; Werner AL;

The recent discovery of small-molecule nitrosamine impurities in marketed drugs, starting with nitrosodimethylamine (NDMA) in batches of Valsartan in 2018, has led to significant regulatory response, including drug recalls and regulatory guidance that requires the evaluation of all synthetic and formulation routes for the potential presence of nitrosamine impurities.

Due to the wide range of potential routes of formation for nitrosamines1 , many active pharmaceutical ingredient (API) structures are themselves liable to be nitrosated, either during the later stages of the synthetic process or as the formulated drug product.

This poster describes the formation of a data-sharing initiative, coordinated by Lhasa Limited, which has the following aims:

? To reduce duplication of testing and make available Ames test results conducted to the highest standards and in appropriate conditions, which will reduce potential uncertainties for regulatory submissions consequently.

? To investigate differences between these compounds and the small molecules which comprise the majority of publicly available nitrosamine data2 and elucidate any structure activity trends and significant differences.

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