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Article CommentaryCommentary

Moving Forward towards Standardized Analytical Methods for Extractables and Leachables Profiling Studies

Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 471-476; DOI: https://doi.org/10.5731/pdajpst.2015.01089
Dennis Jenke
Baxter Healthcare Corporation, 25212 West Illinois Route 120, Round Lake, IL 60073 USA
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Abstract

This commentary considers the standardization of analytical methods used in extractables and leachables screening and proposes that method standardization is not the end goal but rather the necessary first step for enabling efficient, effective, robust, and consistent extractables and leachables profiling. Standardized methods are the platform upon which a knowledge set and a knowledge management process can be built, and it is the combination of the methods, the set, and the process that facilitates extractables and leachables profiling.

  • © PDA, Inc. 2015
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 69 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 4
July/August 2015
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Moving Forward towards Standardized Analytical Methods for Extractables and Leachables Profiling Studies
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jul 2015, 69 (4) 471-476; DOI: 10.5731/pdajpst.2015.01089

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Moving Forward towards Standardized Analytical Methods for Extractables and Leachables Profiling Studies
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jul 2015, 69 (4) 471-476; DOI: 10.5731/pdajpst.2015.01089
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  • Article
    • Abstract
    • Introduction
    • Problem Statement
    • The Challenge of Standardization
    • The Full Promise of Standardization: Profiling Enabled By a Knowledge Set
    • The Curse of Standardization: The Blind Application of Standardized Methods
    • The Question of Who Will Be the Hero
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