Chemical Characterization & Extractables/Leachables
Understanding the chemical composition of materials and the substances they may release during use is critical for ensuring biological safety and regulatory compliance. Chemical Characterization & Extractables/Leachables (E&L) tests identify and quantify chemical constituents, impurities, degradation products, and potential leachable compounds released from materials under controlled, exaggerated, or simulated-use conditions.
At Materials Metric, these studies are performed in alignment with ISO 10993-18, FDA guidance, and Biological Risk Assessment (BRA) frameworks, providing a comprehensive chemical profile to support toxicological risk assessment and biocompatibility evaluation. By combining advanced analytical techniques with scientifically justified extraction strategies, we help clients understand chemical exposure risks, support material selection, and generate defensible data for regulatory submissions across medical devices, biomaterials, and patient-contacting products.
Uses
• Identifying residual monomers, additives, stabilizers
• Screening degradation products
• Detecting extractables under aggressive conditions
• Detecting leachables under real-use conditions
• Supporting toxicological risk assessments
Applications
• Medical devices
• Packaging & tubing
• Pharmaceutical contact materials
• Polymers, coatings, adhesives
Sample Analysis Process
• Extraction per ISO 10993-18
• GC–MS, LC–MS, ICP–MS, FTIR, NMR
• Semi-quantitative and quantitative analyses
• Toxicological relevance assessment
Why Choose Materials Metric
Materials Metric offers end-to-end ISO 10993-18 chemical characterization and E&L analysis with scientific and toxicological depth unmatched by standard laboratories.
We provide:
- Full-spectrum mass spectrometry and chromatography capabilities (GC–MS, LC–MS, ICP–MS, FTIR, NMR)
- ISO 9001:2015 accredited workflows ensuring accuracy, repeatability, and regulatory defensibility
- Toxicological relevance interpretation connecting chemical findings to biological risk
- Integrated chemical + biological correlation to resolve failures or borderline results
- Regulator-ready data formats suitable for FDA 510(k), PMA, and CE Mark submissions
Materials Metric delivers the chemical clarity needed to support Biological Risk Assessments, device safety, and robust regulatory strategy.