Follow-up publication to the FFQM funded project "Detection of unexpected impurities in finished medicinal products."

The working group of Prof. Oliver Scherf-Clavel, Ludwig Maximilian University of Munich, has published a further study on impurities in Lorsatan tablets. The results were recently published in the Journal of Pharmaceutical and Biomedical Analysis: Backer et al „Targeted and untargeted screening for impurities in losartan tablets marketed in Germany by means of liquid chromatography/high resolution mass spectrometry“, https://doi.org/10.1016/j.jpba.2024.116160.

In the present study, the LC-MS/HRMS approach described by Backer et al. for the analysis of known and unknown losartan potassium impurities (https://doi.org/10.1016/j.jpba.2023.115955) was applied to an even more complex system in a larger screening context. The present study included 35 losartan drug products and fixed dose combination products purchased in German pharmacies in 2018 and 2022. The film-coated tablets were analyzed using four LC-MS/HRMS method variants. Differences in the impurity profiles of medicines from 2018 and 2022 were observed.

This study demonstrates that broad screening approaches such as this are applicable to the analysis of pharmaceuticals and can contribute to an important improvement in the quality assurance of medicinal products.