In this presentation at the 2022 Nelson Labs Virtual Symposium, attendees will be taken on a virtual tour of an analytical laboratory where Extractables and Leachables (E&L) studies are performed. This session will provide a comprehensive overview of the equipment used in E&L studies, illustrating where and how it is utilized to generate and evaluate analytical data.
Participants will gain an understanding of the types of equipment essential for E&L studies, such as gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS), and see firsthand how these instruments are employed to analyze samples. The presentation will showcase the analytical data produced by these techniques, explaining how concentrations are estimated and extractables or leachables are identified.
The session will also cover best practices for avoiding and mitigating mistakes during E&L studies, ensuring accurate and reliable results. Attendees will learn about the challenges involved in identifying compounds during the first screening round and explore the next steps for structural elucidation when a compound is not initially identified.
This presentation aims to demystify the E&L study process, providing insights into the meticulous work conducted in analytical laboratories to ensure the safety and compliance of pharmaceutical products. By understanding the analytical techniques and methodologies used, participants will be better equipped to interpret E&L data and apply this knowledge to their own work.
Welcome to the analytical lab—this webinar will offer a detailed and practical perspective on the E&L study process, highlighting the critical role of advanced analytical techniques in ensuring product safety and regulatory compliance. Whether you are involved in pharmaceutical development, quality assurance, or regulatory affairs, this presentation will enhance your understanding of E&L studies and equip you with the tools to conduct and evaluate these studies effectively.