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OtherCommentary

A Safety Risk-Based Extractables and/or Leachables Qualification Strategy for Packaged Drug Products

Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology May 2021, pdajpst.2020.012617; DOI: https://doi.org/10.5731/pdajpst.2020.012617
Dennis Jenke
Triad Scientific Solutions
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Article Information

pdajpst.2020.012617
DOI 
https://doi.org/10.5731/pdajpst.2020.012617
PubMed 
33990423

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received December 10, 2020
  • Accepted April 30, 2021
  • Published online May 14, 2021.

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  • You are currently viewing a previous version of this article (May 14, 2021 - 13:18).
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Copyright & Usage 
Copyright © 2021, Parenteral Drug Association

Author Information

  1. Dennis Jenke1 (dennisjenke{at}triadscientificsolutions.com)
  1. Triad Scientific Solutions
  1. ↵* Corresponding author; email: dennisjenke{at}triadscientificsolutions.com

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  • Extractables and Leachables
    2022
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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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A Safety Risk-Based Extractables and/or Leachables Qualification Strategy for Packaged Drug Products
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology May 2021, pdajpst.2020.012617; DOI: 10.5731/pdajpst.2020.012617

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A Safety Risk-Based Extractables and/or Leachables Qualification Strategy for Packaged Drug Products
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology May 2021, pdajpst.2020.012617; DOI: 10.5731/pdajpst.2020.012617
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More in this TOC Section

  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review
  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
  • Expanding the Use of Moist Heat for Terminal Sterilization
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Keywords

  • chemcial characterization
  • Extractables
  • Leachables
  • Pharmaceutical packaging
  • safety qualification

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