Comprehensive Analysis of Extractables from Rubber Stoppers used in Medical Devices and Pharmaceutical Container Closure Systems

摘要

This study demonstrated a comprehensive workflow for extractable analysis using LCMS, GCMS, ICPMS, and data analysis software. The workflow utilizes unique features of each system to ensure the separation, identification, and characterization of extractables in complex extraction samples. With this workflow, confident and complete extractable and leachable analysis can be accomplished.