University of Wisconsin–Madison

Leachables Stability Studies

When: February 13, 2018 11:00am CST


Leachables are impurities which originate from contact surfaces (typically the final container/closure system). Performing leachable stability studies can be challenging and is generally less understood than for typical drug product related impurities. ICH stability requirements are not directly applicable to leachables. This presentation will cover: what are leachables and where do they come from, what are the similarities and difference to drug product related impurities, what are the method and stability requirements.

About the Speaker: Wayland Rushing, PhD

Over his career, Dr. Rushing has led CMC development programs for a wide array of pharmaceutical products, including parenterals, inhalation drugs, drug/device combinations and other therapies with complex delivery systems. Dr. Rushing is a subject matter expert in HPLC and GC method development and validation, stability testing, extractables and leachables program design and regulatory submission requirements; has drafted multiple IND and NDA submissions. Dr. Rushing is a co-author of PDA Tech Report # 65, Technology Transfer and Tech Report # 76 on Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging.

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