Pharmaceutical products come into contact with a wide range of polymeric materials on their journey from the production line to patients, with possible leaching of potentially dangerous substances into products, possibly compromising the stability, or even worse, the pharmacological activity. Extractable and leachable (E&L) compounds are the focus of rigorous testing workflows to ensure therapeutics are safe and meet regulatory requirements.
This webcast will present an E&L study aiming to address the challenges to achieve sufficient sensitivity and selectivity for unknown analytes potentially present in the sample.
A method has been optimized with the use of static headspace autosampling coupled with a HRAM GC–MS, resulting in a powerful technique to assess and quantify potentially dangerous untargeted volatile extractables down to trace level. Very high mass accuracy with errors of 1 ppm or better, even for smaller molecules and fragments, increases confidence in structure elucidation of unknown compounds.
Key Learning Objectives:
- Learn about streamlining workflow for organic volatile impurities from contact materials
- Learn how to optimize headspace sampling parameters with a strategy based on the theory of gas phase chemistry
- Discover the benefits of using HRAM GC–MS for untargeted or unknown impurities
Who Should Attend:
- Scientists, chemists, and analysts involved in E&L testing
- Laboratory managers in the pharmaceutical industry, CMOs, CROs and contract services
- Researchers and method developers interested in E&L methodology