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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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PDA Journal of Pharmaceutical Science and Technology
Vol. 59, Issue 4
July/August 2005
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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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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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