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Analysis of Extractables & Leachables in Pharmaceutical ...
Analysis of Extractables & Leachables in Pharmaceutical Products Regulatory & Analytical Aspects Andreas Tei Pharmaceutical Segment Manager Agilent Technologies October 2015. Topics Section I. General Aspects and Regulatory Background Introduction Why Worry About Extractables & Leachables (E&L) ? Guidelines Principles of an E&L Study Inorganic Impurities In Pharmaceutical Products Section II. Analytical Approaches to Determining E&L compounds Analytical Technologies and Workflows Elemental Volatile and semi-volatile organics by GC-MS. Non-volatile organics by LC-MS. Compliance Road Show E/L 2015. 2. Introduction Drug Containers And Modern Drug Delivery Systems Drug containers and modern drug delivery systems meant to protect a drug from environmental contamination but they are actually themselves a source of contamination Compliance Road Show E/L 2015.
Cindy Zweiben, Pfizer, Inc., Characterization of Extractables and Leachable in Parenteral Drug Products . Compliance Road Show E/L 2015 5 ... additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established ... Sterile powders Injection powders Inhalation powders
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