The synthesis of pharmaceutical products often involves the use of reactive reagents for the formation of intermediates and APIs. Low levels of reagents or by-products may therefore be present in the final drug product as impurities. Some of these impurities are chemically reactive and may have unwanted toxicities, including genotoxicity and carcinogenicity, with severe impact on product risk assessment. Recently GTIs have gained increased attention and pharmaceutical regulatory authorities carry on issuing guidelines that strict the limits of genotoxins in medicines1. In this EU project2 new purification techniques for the pharmaceutical industry with molecularly imprinted polymers in different formats, e.g. membranes and thin films are developed. Here we report on the synthesis, chromatographic characterisation and removal test, as well as assessment of economical and process application, of the first generation of such materials targeting acetamide and thioacetamide. 1 EMEA/CHMP/QWP/251344/2002 NEMOPUR www3.imperial.ac.uk/molecularpurification (Nr. PITN-GA-2008-214226)

Removal of the genotoxic impurities acetamide and thioacetamde from pharmaceutical formulations using a hybrid approach

243rd National Meeting (2012)

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