Extractables & Leachables Testing

extractable leachable testing

Extractables and leachables are materials that migrate from packaging system components, such as container and closure systems and may contaminate the drug product. A comprehensive approach is required to analyze for the variety of possible extractable and leachable materials.

Extractables and leachables projects will require a study design which is optimized or customized for the pharmaceutical container or closure under investigation, such as materials and their compatibility with extraction solvents, type of container, type of contact between the container and the medicinal product, storage conditions, specific administration or reconstitution procedures, type of medicinal product, route of administration, dosing regimen, and associated threshold requirements.

Exhaustive extractions using solvents with a range of polarity (polar, non-polar, mid-range) may be conducted to identify extractable materials These extractable materials will be referenced against known target compounds from material and container preparation and processing. Leachable materials may be extracted using model solvent system comparable to end use applications. 

 

What are Extractables?

Extractables are compounds that migrate from the contact surface under more aggressive conditions such as elevated temperature, extended contact time, or aggressive solvent system. Any component that is added to or pulled from the device or the materials used to make the device, including degradants and residuals.

 

What are Leachables?

Leachables are compounds that migrate from the contact surface under normal conditions of exposure. Released materials may include plastic components, elastomers, coatings, accelerants, and anti-oxidants. Degradation products from gamma and e-beam sterilization and residual solvents may also be present. 

 

Exrtractables Leachables Available Programs

 

Analytical Techniques

  • Organic analysis by GC, GC/MS, HPLC, LC/MS, LC/MS/MS
  • Elemental analysis by ICP, GFAA and cold vapor AA
  • FTIR and UV/Vis Spectroscopy
  • pH and Total Organic Carbon (TOC) provide non-specific indications of chemical migration
  • Ion chromatography
  • Particle sizing analysis
  • Karl Fischer

 

Exractables Leachables Capabilities

  • Inhalants/MD
  • OINDPs (pMDI, DPI, Nasal Sprays…)
  • Dermal and Topical Applications
  • Biodisposables / Single Use Systems
  • Medical Devices
  • Label/Ink Migration
  • Parenterals/Injectibles
  • Drug Delivery Systems
  • Implants
  • Primary/Secondary Container Closure Systems
  • Raw Material/Polymers
  • Material Characterization
  • Material Comparison
  • Residual Analysis

 

Toxikon Expertise in Extractables & Leachables Testing

Toxikon has developed extensive methodologies for designing studies to identify extractables and leachables in medical devices and pharmaceutical products. The demand for these types of studies by U.S. and other governing bodies is increasing, as data from these assessments identifies potential contaminants that migrate from containers, closure systems, tubing, and other materials, potentially rendering drug products unsafe. These materials include, but are not limited to polymers and other plastics, elastomers, coatings, accelerants, and antioxidants. Degradation products from gamma to e-beam sterilization processes to residual solvents from manufacturing may also be present.

Toxikon uses a combination of commercially-available reference database as well as a proprietary database, built over the last ten years, based on thousands of studies conducted.   

 

White Paper

Download this educational white paper to learn more about extractables and leachables testing. 
 
Identifying Unexpected Impurities in Drug Products: A Challenging Task
 
Extractables & Leachables Testing
Extractables and Leachables, Extractables & Leachables, Extractables & Leachables Testing, Organic analysis, GC, GC/MS, HPLC, LC/MS, LC/MS/MS, Elemental analysis, ICP, GFAA, cold vapor AA, FTIR, UV/Vis Spectroscopy, pH, Total Organic Carbon, TOC, non-specific indications, chemical migration, Ion chromatography, Particle sizing analysis, Karl Fischer
Extractables and leachables are materials that migrate from packaging system components, such as container and closure systems and may contaminate the drug product.A comprehensive approach is required to analyze for the variety of possible extractable and leachable materials. Contact Tocikon today for Extractables and Leachables Testing offerings.