How to Achieve Confident Identification during Extractables and Leachables Analysis

Background

Extractables and leachables (E&L) from pharmaceutical packaging, medical devices and process equipment can potentially pose risks to the safety, efficacy, and stability of pharmaceutical or medical products. As part of safety risk assessment, it is very important to confidently identify those E&L compounds. However, the confident identification of extractables and leachables can be challenging due to the diverse chemical structures and properties of polymer additives found in the manufacturing and packaging components, and medical devices.

Agenda

• Extractable and Leachables (E&L) Identification (ID) Category per USP
• Approaches to Achieve More Confident ID by LC/MS and GC/MS
• A Case Study to Investigate a Leachable from Secondary Packaging by GC-HRMS:
  • Investigate the Sources of the Unknown Leachable
  • Unknown ID by Running GC-HRMS in Both EI and CI Modes
  • Structure Elucidation of the Compound by MS/MS in HRMS to Obtain Correct Fragmentation Pathway, Compared to Incorrect Information in the Current Literature

Objective

The objective of this webinar (35-minute presentation /10-minute Q&A) is to go through the levels of identification confidence illustrated in USP and strategies to achieve confident identification. A case study will also be shown regarding fragmentation mechanism of a cyclic ester, which was found as a leachable from secondary packaging.

Target Audience

The webinar is aimed at:

• Managers, scientists and engineers who are involved in the extractables and leachables filed
• Analytical chemists who are interested in new techniques in terms of confident organic compound identification
• Anyone interested in subcontracting E&L testing

Language: English
Cost: No charge