Studied chemistry at University of Paderborn; Dipl.-Chem. (M.Sc.) in Inorganic Chemistry (cluster synthesis and structural analysis)
Moved for Ph.D. studies to Department for Mechanical and Environmental Engineering at University of Paderborn; Dr.-Ing. (Ph.D., development of recycling plant)
Joint Sciex in 2002 as Support Specialist
To ensure patient safety, regulatory agencies have put in place guidelines which mandate the identification and profiling of impurities in APIs and formulated drug products and sets thresholds at which these impurities must be reported.
The Valsartan case, has shown the need for the implementation of the state of the art technology in the QC/QA laboratories. A creation of a fast, high throughput, robust, and reproducible analytical technology and method (e.g., LC-MS) is critical for increased confidence in impurity identification, detection, and quantification in pharma research to increase the safety of the end product. This critical information speeds drug candidate development from IND-enabling studies to NDA.
In our presentation we show how the combination of the speed, sensitivity and resolution on the latest QTOF technology can help to solve the questions related to the characterization and quantiation of impurities, with a system and solution that: