Extractables & Leachables Testing Analytical Techniques

    When developing the methods needed for extractables & leachables testing, Smithers Rapra uses a variety of different analytical techniques. The analytical testing methods chosen need to be robust, repeatable and precise since they will be used to analyze samples over a period of up to three years. The extractables and leachables testing analytical techniques we employ include:

    • Gas chromatography (GC-MS) with Mass Spectrometry
    • Liquid chromatography (LC-MS) with Mass Spectrometry
    • Inductively coupled plasma (ICP)
    • Fourier transform infrared spectroscopy (FTIR)
    • Gravimetric analysis
    • Special case compound analysis

    These analytical testing techniques provide stability testing at the point of use, ensure that packaging materials are safe, and present an acceptable risk of contamination for particular products. By using these extractables & leachables testing methodologies, Smithers Rapra is able to help clients ensure patient safety and confidence in their drug product.

    Request a quote today for our extractables & leachables testing services.