Nitrosamines, or more correctly N-nitrosamines, refer to any molecule containing the nitroso functional group. Thesemolecules are of concern because nitrosamine impurities are probable human carcinogens. Although they are alsopresent in some foods and drinking water supplies, their presence in medicines is nonetheless consideredunacceptable.
To ensure the safety of the U.S. drug supply, FDA has launched the availability of a guidance for industry, entitled“Control of N-Nitrosamine Impurities in Human Drugs.” This guidance recommends steps manufacturers of activepharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamineimpurities in pharmaceutical products. The guidance also describes root causes that may introduce nitrosamineimpurities.
The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during themanufacture of human medicines and has provided guidance to marketing authorization holders to avoid the presenceof nitrosamine impurities. EMA finalized a review under Article 5(3) of Regulation (EC) No 726/2004 in June 2020 toprovide guidance to marketing authorization holders on how to avoid the presence of nitrosamine impurities in humanmedicines.Companies are required to have appropriate control strategies to prevent or limit the presence of these impurities and,where necessary, to improve their manufacturing processes. The 2nd edition of Nitrosamine Impurities Forum scheduled on 29-30 June 2021 will discuss on the current challenges & future perspective.