Chemical substances contained in polymer container closure systems (CCS) and drug delivery systems may migrate into drugs during production, storage, transportation, and delivery processes. Therefore, to ensure drug safety, identification must be conducted in the final product.

This application brief introduces a study on rubber pad leachables, using unit mass resolution gas chromatography/mass selective detector (GC/MSD) and high-resolution gas chromatography/quadrupole time-of-flight (GC/Q-TOF) mass spectrometer to establish an identification process for leachables and leachables (E&L) suitable for GC analysis.