This year's PQRI workshop examines the affects substances extracted by drug products from their container closure systems have on drug product's effectiveness. With limited direction from regulatory authorities regarding the analysis and toxicological safety assessment of such substances, the PQRI has issued a recommendation to provide a scientific method and process to identify, quantify and qualify leachables and/or extractables in orally inhaled and nasal drug products (OINDP). Recognizing that the OINDP recommendations could have general applicability in other dosage forms such as PODP, this year's PQRI workshop will be the first opportunity of the PODP leachables and extractables work group to present and discuss its findings. The experience and insights of the workshop participants shared at these working sessions will contribute to ongoing development of the recommendations.
Dr. Alan Hendricker is the Principal Scientist of Structural Chemistry at Catalent's facility in Research Triangle Park, NC. He initially worked at Magellan Laboratories in its structural chemistry group specializing in mass spectral extractable/leachable profiling of container-closure systems, device componentry, drug product packaging materials and drug products for the pharmaceutical industry. Dr. Hendricker utilizes analytical techniques such as gas chromatography mass spectrometry (GC-MS), liquid chromatography mass spectrometry (LC-MS), inductively coupled plasma mass spectrometry (ICP-MS), and headspace analysis for volatile impurities. In 2006 Dr. Hendricker became a member of the PQRI working group and helped to develop the Safety Threshold and Best Practices for Extractables and Leachables in OINDP.
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