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Extractables & Leachables Testing

Extractables and leachables can pose a serious risk in vascular applications.  When elements and compounds leach into your products, from packaging or manufacturing environments, they can render them unfit and even dangerous for use.

At Lucideon, we test for what does leach and all potential extractables in your process and packaging.

Our experts provide Extractables and Leachables (E&L) testing to USP<1663> and <1664> for drug products and ISO 10993 for medical devices.

Extractables

Identify substances which could potentially migrate from polymeric, metallic or glass material into the patient or consumer; examples include dyes, catalysts and plasticizers.  The extractions follow ISO 10993 or USP <1663> and typically cover a range of solvent polarities or similar extraction media to the drug product formulation.  Our experts use a wide range of techniques including LC-MS, GC-MS and ICP-MS.

Leachables

Identify substances which do migrate from materials into the patient, typically a subset of those identified in the extractables analysis.  This type of analysis is particularly suited to liquid products, e.g. eye drops, where there is a risk of harmful substances leaching into the solvent from its container or packaging.

To help you gain regulatory approval, we also carry out E&L testing on materials used in production systems, delivery systems, and container closure systems.  We develop a customized profile of all potential extractable compounds that could leach into your pharmaceutical product.  This makes it quick and easy to identify leachables and therefore the toxicological risk.

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Resources

  • White Paper

    Chemical Imaging of Industrial and Healthcare Materials by ToFSIMS
    pdf (1.79 MB)

  • White Paper

    Are you Ready for USP <232>/<233>?
    pdf (247 KB)

  • Data Sheet

    • Vascular Devices Services Portfolio

    Download PDF