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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleRESEARCH

Linking Extractables and Leachables in Container/Closure Applications

Dennis R. Jenke
PDA Journal of Pharmaceutical Science and Technology July 2005, 59 (4) 265-281;
Dennis R. Jenke
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Article Information

vol. 59 no. 4 265-281
PubMed 
16218205

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online July 1, 2005.

Copyright & Usage 
Copyright © Parenteral Drug Association. All rights reserved.

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  1. Dennis R. Jenke
  1. Technology Resources Division, Baxter Healthcare Corporation, Round Lake, IL 60073

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    Vol. 59, Issue 4
    July/August 2005
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    PDA Journal of Pharmaceutical Science and Technology Jul 2005, 59 (4) 265-281;

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    Linking Extractables and Leachables in Container/Closure Applications
    Dennis R. Jenke
    PDA Journal of Pharmaceutical Science and Technology Jul 2005, 59 (4) 265-281;
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    Cited By...

    • Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)
    • Introducing the Alba(R) Primary Packaging Platform. Part 2: Inorganic Extractables Evaluation
    • A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
    • Low Leachable Container System Consisting of a Polymer-Based Syringe with Chlorinated Isoprene Isobutene Rubber Plunger Stopper
    • Extractables Analysis of Single-Use Flexible Plastic Biocontainers
    • A Method Utilizing Ultra-High Performance Liquid Chromatography with Ultraviolet and Mass Spectrometric Detection for the Analysis of Material Extracts Produced during a Controlled Extraction Study
    • Identification of a Leachable Compound Detrimental to Cell Growth in Single-Use Bioprocess Containers
    • Identification of an Extraneous Black Particle in a Glass Syringe: Extractables/Leachables Case Study
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    More in this TOC Section

    • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
    • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
    • A Proof-of-Concept Study on a Universal Standard Kit to Evaluate the Risks of Inspectors for Their Foundational Ability of Visual Inspection of Injectable Drug Products
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