Plasticizers Analysis in Extractables and Leachables by Gas Chromatography-Mass Spectrometry with Parallel...

Area of Science:

• Analytical Chemistry
• Materials Science

Background:

• Plasticizers like phthalates are common extractables and leachables (E&Ls) in medical devices.
• Regulatory bodies mandate E&L monitoring for medical device safety.
• Analyzing complex E&L matrices poses significant challenges.

Purpose of the Study:

• To evaluate a novel Polyarc/Flame Ionization Detector (FID) system for analyzing E&Ls from medical devices.
• To demonstrate the quantitation of unknown E&Ls without pure substance calibration.
• To combine screening and target analysis into a single, efficient method.

Main Methods:

• Utilized a full scan Gas Chromatography-Mass Spectrometry (GC-MS) coupled with a parallel Polyarc/FID system.
• Identified E&Ls using GC-MS and quantified them via Polyarc/FID response factors from internal standards.
• Applied the method to a polyvinyl chloride medical device sample.

Main Results:

• The Polyarc/FID system enabled accurate quantitation of E&Ls without requiring individual pure substance standards.
• Quantitation accuracy was improved by using response factors from internal standards.
• The method successfully quantified acetyl tri-n-butyl citrate, trioctyltrimellitate, and di-(2-ethylhexyl) phthalate (DEHP) in a PVC medical device.

Conclusions:

• The Polyarc/FID system offers a feasible and effective solution for E&L analysis in medical devices.
• This approach simplifies the quantitation of unknowns, eliminating the need for extensive standard libraries.
• The integrated screening and target analysis capability makes it highly desirable for routine E&L monitoring.