Gyorgy Vas | Authors

These case studies illustrate how the pharmaceutical industry utilizes mass spectrometry–based solutions to address product quality concerns, particularly when extremely low detection limits are required and when development resources are limited.

Extractable and leachable (E&L) testing for finished pharmaceutical products, bioprocess manufacturing systems, and medical devices is currently a subject of intense interest. The majority of the challenges encountered in analytical workflows are related to the highly complex matrices and relatively low analyte evaluation thresholds seen in E&L studies. This paper provide options for executing E&L testing to supporting regulatory submissions. There are multiple compliant routes possible, and the presented workflows and analytical solutions are only one of multiple successful approaches.