Funding project: Detection of unexpected impurities in finished medicinal products

The Frankfurt Foundation Quality of Medicines is now funding a total of four experimental study projects. Today we would like to briefly introduce the first one. This is focused on the analysis of possible contaminations of active pharmaceutical ingredients using losartan as an example. The occurrence of unexpected impurities in finished drug products – e.g., in valsartan preparations in 2018 – had elucidated how important the development of sophisticated analytical procedures is when creating impurity profiles.

Professor Dr. Oliver Scherf-Clavel is responsible for this project. Together with other scientists he had previously examined various sartans for nitrosamine impurities using a high-resolution chromatographic system (QqTOF-LC/MS). They were able to discover unexpected contaminations that could not be detected with the common methods (e.g., those suggested by the pharmacopoeia).

The research project supported by our foundation now aims to develop a general procedure for the „untargeted“ analysis of active drug ingredients in order to be able to discover unknown – and above all unexpected – impurities. This project is of great practical relevance for drug therapy as drug safety finally ensures patient safety.

Professor Oliver Scherf-Clavel was the award winner of the FFQM/DPhG 2021 „Quality of Medicines Award“ during his time as a junior professor at the Julius-Maximilians-University in Würzburg. This award recognized his research work on the contamination of valsartan and other sartans. Scherf-Clavel was recently appointed to the W2 professorship for „Clinical Pharmacy and Pharmacotherapy“ at the Ludwig-Maximilians-University in Munich.