Chemical Analysis of Pharmaceutical and Food Packaging (Extractables and Leachables Analysis)
Sunday, March 8, 2026 1:00 PM to 5:00 PM · 4 hr. (America/Chicago)
Short Course Office - Room 211
Short Course
Pharmaceutical & Biologics
Information
This course offers practical training for the analytical chemists who are interested in chemical analysis of pharmaceutical and food packaging. It will take the participants step-by-step through the concepts and techniques to design extractables and leachables (E&L) analysis for pharmaceutical and food packaging. The emphasis is on practical analytical techniques associated with extractables and leachables analysis, such as GC-MS and LC-MS. It also emphasizes recent new industry guidance around chemical analysis of pharmaceutical and food packaging. This course will provide the participants with an updated overview of the recent regulatory guidance and a solid working knowledge of LC-MS and GC-MS analytical challenges during the E&L testing. The participants will learn most up-to-date E&L regulations, study designs, and major analytical challenges associated GC-MS and LC-MS unknown identification and quantitation. After this course, the participants will be able to independently design the chemical analysis of pharmaceutical packaging and develop their own analytical methods for E&L analysis.
Day of Week
Sunday
Session Number
SC-7333
Application
Pharmaceuticals
Methodology
Mass Spectrometry
Primary Focus
Application
Morning or Afternoon
Afternoon
Short Course Information
Course Level
Beginner
Duration
Half Day Course
Learning Objective
1. Fully understand the regulatory requirements associated with chemical analysis of pharmaceutical and food packaging.
2. Learn about the key concepts on unknown identifications of extractable and leachable compounds by LC-MS and GC-MS.
3. Learn about the importance of semi-quantitation and full analytical method validation during the extractables and leachables analysis.
Course Outline
1. Introductions to Extractables and Leachables
Key Guidance related to chemical analysis of pharmaceutical and food packaging, such as USP <1663>, <1664>, <665>/<1665>.
2. How to design an extractable study
Selection of extraction solvents, temperature, duration, techniques.
How to calculate analytical evaluation threshold (AET),
How to develop E&L screening methods, such as Headspace-GC-MS, Direct Injection-GC-MS, LC-MS, etc.
3. How to design a leachable study
Leachable testing schedule and bulk control selection,
Leachable quantitation (full analytical method validation vs. qualified screening method),
Leachable simulation Study to bridge the gap between controlled extraction study and leachable stability study.
4. E&L unknown identification by GC-MS and LC-MS
Strategies on how to identify unknowns during GC-MS and LC-MS analysis.
5. Analytical uncertainty factors during Semi-Quantitation of the E&L analysis
Target Audience
Analytical chemists, supervisors, lab managers, and researchers who are interested in the chemical analysis of pharmaceutical and food packaging. It will benefit the scientists ranging from college graduates to professionals in the analytical field in the pharmaceutical, biotech, food, medical device, CRO and other industries.
Early Fee (before Jan 29, 2026)
$450.00
Full Fee (after Jan 29, 2026)
$550.00
Register
No Registered for Pittcon? Register Now!
