About Extractables & Leachables Testing

Products that often undergo extractables and leachables testing include medical devices, pharmaceutical packaging, single-use bioprocess components, food contact materials, and other consumer goods.

Regulatory bodies often require extractables and leachables testing for a variety of products. Producers of medical devices, pharmaceuticals and consumer products use the data from an extractables and leachables study to perform a risk assessment of their overall process.

When not required by a regulatory body, extractables and leachables testing is a proactive approach to ensuring high standards are met.cts.

  • Approaches

    Liquid Chromatography-Mass Spectrometry (LC-MS) has emerged as the  technique of choice for extractables and leachables testing, due to its high sensitivity for detecting trace components of a mixture. Additionally, its ability to identify these trace components is very valuable. A high-resolution accurate-mass LC-MS, such as ourquadrupole time-of-flight (qTof) instrument, is especially helpful for extractables and leachables testing.  The high mass accuracy of this instrument allows compounds to be identified with a high degree of certainty, even for unexpected compounds. A qTof instrument can also produce ion fragmentation patterns, which are used as fingerprints to give additional confidence in the identification of a compound. Paired with Cheminformatics software, parent and fragment ions can be matched to each other, assisting in data interpretation. 

    For volatile and semi-volatile compounds, Gas Chromatography-Mass Spectrometry(GC-MS) can be used to separate, quantify, and identify extractables and leachables. However, non-volatile components and oligomeric degradation products are typically out of scope for GC-MS.

  • Sample Considerations

    The sample requirements need to be discussed on a project specific basis because the specific parameters of the extractables and leachables tests will dictate the amount of sample. 

    Our staff will guide the process to ensure the proper amount of a sample is submitted in order to achieve excellent extractable and leachables data. Contact us with specific questions about your extractables and leachables testing needs.

  • Experience

    Extractables and leachables analysis is critical for medical devices, pharmaceutical products, packaging, and materials that come in contact with food. We have experience within all of those categories, some specific examples include:

    • Pre-filled syringes
    • Vials
    • Packaging for surgical supplies
    • Components of metered dose inhalers
    • Medical tubing