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.

Related services

To learn more about our Chemical Characterization & Extractables/Leachables or other testing needs, please contact us.

Frequently Asked Questions

What is chemical characterization for extractables and leachables?

Extractables and leachables (E&L) chemical characterization identifies and quantifies chemical substances that can migrate out of a material into a product, patient, or environment. Extractables are released under exaggerated laboratory conditions, while leachables migrate under normal use; both are analyzed by chromatography and mass spectrometry. Materials Metric performs E&L studies to support biocompatibility and safety assessments of devices, packaging, and container-closure systems.

What can extractables and leachables studies detect?

They can detect and identify organic and inorganic compounds such as residual monomers, additives, processing aids, degradation products, and trace elements released from a material. Analyses typically combine GC-MS, LC-MS, ICP-MS, and headspace techniques to capture volatile, semi-volatile, nonvolatile, and elemental species. Results feed a toxicological risk assessment against safety thresholds.

What sample is required for extractables and leachables studies?

Representative articles, components, or materials in the configuration that contacts the product are required, along with details of the contact conditions, duration, and media. Sufficient quantity is needed to perform multiple extraction conditions and replicate analyses. Materials of construction, process history, and intended use are essential for designing the study.

Which standards apply to extractables and leachables studies?

E&L chemical characterization is commonly performed within the ISO 10993 series, particularly ISO 10993-18 for chemical characterization, supported by validated or fit-for-purpose methods aligned with ASTM, ISO, and USP where applicable. The applicable framework depends on the application and regulatory context. Study design is tailored to the material, exposure, and risk assessment needs.