Tips and Tricks for Extractables & leachables Studies of Medical Devices

Extractables and leachables (E&L) characterization has become crucial for ensuring product quality and safety across various industries, including medical devices, pharmaceuticals, and food products. The diverse nature and complexity of medical devices present unique analytical challenges that differ significantly from those associated with packaging systems. This presentation will share practical tips and tricks to address common challenges encountered during extraction, sample analysis, and unknown identification through manual interpretation of mass spectra. Key topics will include the use of orthogonal techniques to tackle extract precipitation and polymer composition, strategies for mobile phase selection, identification of multi-charged mixed adducts, and approaches for holistic identification of extractables/leachables.