In 2018, nitrosamine impurities were detected in the blood pressure medication of the Sartane group. Nitrosamines are potentially carcinogenic. Although the risk of these compounds being carcinogenic to humans is very low, the European Medicines Agency (EMA) has called for the holders of marketing authorisations for placing these raw materials on the EU market to undergo analyses. These analyses are intended to determine the extent to which the raw materials or manufacturing conditions may possibly lead to the formation of nitrosamines or the extent to which nitrosamine compounds are present in these active substances and medicinal products. If confirmed, it should be examined how this risk of nitrosamine or nitrosamine compounds formation can be reduced.
Nitrosamine Impurities
Jul 8, 2020 | Manufacturing Process