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Extractables and Leachables

Toxikon Corporation offers a comprehensive approach to analyze a variety of possible extractable and leachable materials.

Extractables are compounds that migrate from the surface under more aggressive conditions such as elevated temperature, extended contact time, or aggressive solvent system. Leachables are compounds that migrate from the contact surface under normal conditions of exposure.

Toxikon uses a number of techniques in the analysis of extractables/leachables such as:

  • Organic analysis by GC, GC/MS, HPLC, LC/MS, LC/MS/MS
  • Elemental analysis by ICP, GFAA, ICP/MS
  • FTIR and UV/Vis Spectroscopy
  • PH, conductivity, and Total Organic Carbon (TOC), which provides non-specific indications of chemical migrations

Whatever your product requirements, Toxikon can provide analytical services applicable to all phases of product development. Toxikon can characterize raw materials, conduct material comparisons, provide ongoing QC validation support for manufacturing residuals, and test for byproducts of sterilization.