Chemical Characterization

Chemical characterization incorporates a variety of analytical techniques to identify and quantify materials that may have migrated from the product contact material into the solution of interest. This testing service is often used to identify product materials, detect the presence of impurities or create a chemical profile of an unknown formulation.

Understanding Chemical Characterization Testing

The purpose of this testing is to determine a baseline to the extractable amount of chemical compounds present in and on a medical device and utilize extraction conditions similar to those utilized in biocompatibility determination of similar devices.

Chemical Characterization Techniques

  • Gas Chromatography/Mass Spectrometry (GC/MS): Analyzes the extract samples for Volatile Organics Compounds (VOC) and Semi-Volatile Organic Compounds (SVOC)
  • Liquid Chromatography/Mass Spectrometry (LC/MS): Analyzes the extract samples for target Non-Volatile Organic Compounds (NVOC).
  • LC Chromatogram: Utilizing a UV detector to determine the presence of peaks corresponding to non-target NVOC.
  • Inductively Coupled Plasma (ICP): Analyze the extract samples for metals.

Standards

For “borderline products”, some container/closure systems may either be considered as a pharmaceutical container or as a medical device. For medical devices, appropriate testing according to the ISO 10993 Standard series should be performed.

  • ISO 10993 – Part 3: Tests for Genotoxicity, Carcinogenicity, Reproductive Toxicity
  • ISO 10993 – Part 4: Selection of Tests for Interactions with Blood
  • ISO 10993 – Part 5: Tests for In-Vitro Cytotoxicity
  • ISO 10993 – Part 6: Tests for local Effects after Implantation
  • ISO 10993 – Part 10: Tests for Irritation and delayed-type Hypersensitivity
  • ISO 10993 – Part 11: Tests for Systemic Toxicity
  • OECD 471: AMES testing (Mutagenicity)
  • ISO 10993 – Part 18 Chemical Characterization

Toxikon’s Expertise in Chemical Characterization

Toxikon provides analytical services applicable to all phases of product development. This includes characterizing raw materials for container/closure and disposable systems, conducting material comparisons, providing ongoing QC validation support for manufacturing residuals, and testing for byproducts of sterilization.