Leachable and Extractable Testing

Characterization of Materials for Extractable and Leachable Components


Impact Analytical has extensive experience performing extractable and leachable testing on various samples and materials.   We have proprietary methods developed for exhaustive extraction of all polymer material types.  Following extraction, we utilize our separations and molecular characterization laboratories to fully identify any extractables.  Depending on customer need, we can also provide accurate quantitation.


Leaching studies can be extremely important during medical device, packaging and drug development.  Regardless of your extractable and leachable testing need, Impact Analytical has the experience and capabilities to help.  All extractable and leachable studies can be performed under cGMP conditions.  Some examples of our extractable and leachable projects include:

  • Analysis of Extracts by LC-MS for Quantitation of Leachables in Silicone Carrier/Release Liners
  • Analysis of Pulmonary Device for Residual Process Detergents
  • Characterization of Raw Materials for Leachables
  • Carbon Black Leachable Studies
  • BPA Leaching Studies
  • Characterization of Epoxy Extractables
  • GLP Extraction Studies of Packaging and Polypropylene Bottle Components
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