Increased Confidence in Untargeted Volatile E&L Analysis by Static Headspace Sampling Coupled to HRAM GC-MS
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
Presenter: Xiaotend (Shelton) Gong (Instrumentation Chemist, Extractable and Leachable (E&L) Testing, SGS)
Xiaoteng Gong received his Master’s degree from the Illinois Institute of Technology, and has worked on food contact materials at the National Center for Food Safety and Technology (NCFST) of the Food and Drug Administration (FDA). With extensive experience in analytical chemistry, he currently is an instrumentation chemist at SGS specializing in extractables and leachables (E&L) studies for pharmaceutical packaging. He has more than five years of experience using headspace gas chromatography–mass spectrometry (GC–MS).
Presenter: Daniela Cavagnino (Marketing Manager, GC-MS, Thermo Fisher Scientific)
Daniela Cavagnino received a Master’s degree in Chemistry from the University of Milan, Italy. She started her career in gas chromatography at Thermo Fisher Scientific, spending several years in the R&D laboratories working on GC technology innovation. Then, she conveyed her technical background into product management and marketing management roles, and she now has more than 15 years of experience promoting GC and GC–MS technology and applications in several different market segments. During her career, she has participated as an author and co-author in technical publications and as a lecturer at international conferences.
