Extractables and Leachables Testing
Regulatory agencies require biopharmaceutical manufacturers who utilize drug delivery devices, single-use manufacturing systems, and container closure apparatuses to submit toxicological Risk Assessments based on chemistry data generated by extractables and leachables testing. All testing is designed to support drug manufacturers from early stages through to commercial batch release in compliance with ICH guidelines and FDA/EMA regulations.
Through investment in technology and expertise, we have developed a multi-tiered analytical methodology to extractables and leachables testing that provides complete chemical characterization, enabling accurate assessment of any potential hazards.
Our Approach to Complete Chemical Characterization and Risk Assessment
Testing - Full Range of Chemical Detection
- Headspace Gas Chromatography (with mass spectrometry) for analysis of volatile organic compounds
- Direct inject gas chromatography (with MS) for analysis of semi-volatile organic compounds
- Liquid Chromatography (with MS) for analysis of non-volatile organic compounds
- Inductively coupled plasma for elemental analysis
Risk Assessment Report
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