Extractables and Leachables: Overcoming Analytical Challenges with GC-MS

Join Jack Stuff, Ph.D,  Senior Analytical Research Scientist at GERSTEL, Inc., and Michael Louis, Senior Chemist at Jordi Labs, for presentations on GC-MS techniques for Extractables and Leachables (E&L) studies.

The webinar will consist of the following lectures:

Direct Thermal Extraction (DTE), Stirbar Sorptive Extraction (SBSE), and Dynamic Headspace (DHS) for E&L Studies

This talk will discuss thermal desorption-based techniques, Direct Thermal Extraction, Stirbar Sorptive Extraction, and Dynamic Headspace, as applied to the determination of extractables, leachables, and migratables. Specific examples for each technique will be given.

Presenter: Jack Stuff, Ph.D.

Addressing Analytical Challenges in HS-GC-MS: From Response Factors to Matrix Effects

Headspace gas chromatography mass spectrometry (HS-GC-MS) stands as a pivotal technique for the detection and quantification of volatile extractable chemicals in medical devices. However, the accuracy and reliability of HS-GC-MS can be significantly impacted by various sources of experimental error. The critical aspects of error in HS-GC-MS analyses will be discussed with a focus on understanding the critical differences in errors that occur due to headspace sampling contrasted with liquid injection methods.

A key source of error in all techniques applied to chemical characterization that rely on quantification with surrogates (relative quantification) is response factor variation.  The E&L industry is grappling with this issue with an effort to understand and address errors and avoid underreporting of chemicals.  Depending on methodology, HS-GC-MS is subject to additional problems that, in some cases, can be more significant than response factor variation. We will explore these challenges in detail and discuss strategies to minimize their impact. 

Presenter: Michael Louis