Extractables & Leachables Testing Methodology

    When conducting extractables & leachables testing, a specific methodology must be followed to ensure that tests are conducted precisely and accurately. Smithers Rapra follows a three-step methodology for extractables & leachables testing:

    • Extractables profile. This is the most important phase of testing since all other decisions will be based on the extractables profile. Once the profile for the container closure system is determined, methodology can be further developed to enable leachables assessment.
    • Validation of Leachables. Suitable sample preparation and methods for analysis of the leachables in the presence of drug and excipients are developed and validated to enable quantitative assessment of leachables in the final drug product solution.
    • Leachables Testing. Validated methodology, using a variety of analytical techniques, is used to demonstrate the presence of leachables, if any, during the shelf life of the OINDP or PODP in its final container closure configuration.

    Smithers Rapra has extensive experience conducting extractables & leachables testing for a wide range of clients. These clients experience continued success and have not had a submission rejected by any regulatory organization.

    Let us help you ensure that your drug product meets regulations. Request a quote for our extractables & leachables testing services.?