Extractables & Leachables Analysis for Pharmaceutical and Medical Products
Monday, March 3, 2025 9:30 AM to 12:00 PM · 2 hr. 30 min. (America/New_York)
Room 206A
Organized Session
Pharmaceutical & Biologics
Information
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. This session will highlight multiple analytical techniques used to identify and quantify E&L, such as GC-MS, LC-MS, and ICP-MS.
Day of Week
Monday
Session or Presentation
Session
Session Number
OC-06-00
Application
Pharmaceuticals
Methodology
Mass Spectrometry
Primary Focus
Application
Morning or Afternoon
Morning
Register
Register Now
Presentations
Method Validation Challenges in Extractables and Leachables Analysis
Monday, March 3, 2025 9:30 AM to 9:50 AM
Room 206A
Gagandeep Singh · Nexus pharmaceuticals
Using LC-QTof-MS to Identify HTPE Related Extractables and Leachables Compounds from Polymer Filter with Oligomer Hindered Amine Light Stabilizer (HALS)
Monday, March 3, 2025 9:50 AM to 10:10 AM
Room 206A
Xiaoran Zhang · Cytiva
ELSIE's Lab Practices Working Group's Proposal for Best Practices to Improve the Consistency of Extractable Screening Data Between Laboratories
Monday, March 3, 2025 10:10 AM to 10:30 AM
Room 206A
Steve Zdravkovic · Baxter Healthcare Corporation
Extractable/Leachable Analysis: Using Chromatography, Databases and Mass Spectral Data to Improve Compounds Identification in Commercially Available Catheters
Monday, March 3, 2025 10:40 AM to 11:00 AM
Room 206A
David Weil · Agilent Technologies
Simultaneous Targeted and Non-targeted PFAS Screening as Part of the Extractables Analysis of Pharmaceutical Container Closure, Manufacturing Components and Medical Device Materials by LC-HRMS
Monday, March 3, 2025 11:00 AM to 11:20 AM
Room 206A
Dujuan Lu · SGS Pharma
Case Study: Migration of PFAS from Fluoropolymers used as Single-Use Processing Components in the Manufacture of Cell & Gene Therapy Products
Monday, March 3, 2025 11:20 AM to 11:40 AM
Room 206A
Sam Albeke · Element Materials Technology
Tips and Tricks for Extractables & leachables Studies of Medical Devices
Monday, March 3, 2025 11:40 AM to 12:00 PM
Room 206A
Yunyun Yuan · Johnson & Johnson MedTech