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March 18, 2010
Leachables and Extractables: Regulatory Context
Keynote speaker for this event:
  • Alan D. Hendricker, Ph.D.,  Principal Scientist, Catalent Pharma Solutions  Learn More
  • Leachables and Extractables: Regulatory Context

    This presentation provides an introduction to the regulatory documents surrounding leachables and extractables testing requirements for pharmaceutical products intended for US submission.

    The regulatory documents covered will include those for MDI, DPI, nasal spray, topical, oral and parenteral drug products. In addition to FDA guidance for container closure systems and devices, the presentation will explore other applicable guidance and recommendation documents including: ICH guidance, Product Quality Research Institute (PQRI) recommendations and EMEA and FDA guidance on genotoxic and carcinogenic impurities.

    Finally, flowcharts on how to put the guidance into action will be shown including component selection for study, analytical technology to employ and overall extractables and leachables program strategy.

    Key takeaways:

    • An understanding of the regulatory documents surrounding extractables and leachables testing
    • Modern approaches and strategy to extractables and leachables testing
    • Putting the guidance into action in the analytical laboratory

    Managers, Directors, Vice President’s of small and large Pharma that are working in product development of all dosage forms



    Alan D. Hendricker, Ph.D.,  Principal Scientist, Catalent Pharma Solutions  

    Dr. Hendricker received his B.S. in Chemistry from Ohio University in Athens, Ohio, USA, and his Ph.D. in Chemistry from the Colorado School of Mines in Golden, Colorado, USA. In January of 1999, he joined Magellan Laboratories to work in its Structural Chemistry Group, focusing on mass spectral extractable/leachable profiling of container-closure systems, device componentry, drug product packaging materials and drug substances for the pharmaceutical industry. He specializes in gas chromatography mass spectrometry (GC-MS), liquid chromatography mass spectrometry (LC-MS), and headspace analysis for volatile impurities. Dr. Hendricker was a member of the PQRI working group which developed the Safety Threshold and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products in 2006. Magellan Laboratories was acquired by Cardinal Health’s Pharmaceutical Technologies & Services segment in 2002, which in 2007 became Catalent Pharma Solutions.


    Catalent Pharma Solutions provides expert extractables and leachables services to the pharmaceutical industry with a focus on applying their industry-leading scientific, regulatory and compliance expertise to all dosage forms and drug delivery platforms.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

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