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OtherCommentary

How One Might Experimentally Determine if Container Closure Systems and their Components and Materials of Construction Contribute Elemental Impurities to Packaged Pharmaceutical Drug Products

Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology September 2018, pdajpst.2018.008938; DOI: https://doi.org/10.5731/pdajpst.2018.008938
Dennis Jenke
Triad Scientific Solutions
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Article Information

pdajpst.2018.008938
DOI 
https://doi.org/10.5731/pdajpst.2018.008938
PubMed 
30232139

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received May 4, 2018
  • Accepted August 9, 2018
  • Published online September 19, 2018.

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  • You are currently viewing a previous version of this article (September 19, 2018 - 09:44).
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Copyright & Usage 
Copyright © 2018, 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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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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How One Might Experimentally Determine if Container Closure Systems and their Components and Materials of Construction Contribute Elemental Impurities to Packaged Pharmaceutical Drug Products
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Sep 2018, pdajpst.2018.008938; DOI: 10.5731/pdajpst.2018.008938

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How One Might Experimentally Determine if Container Closure Systems and their Components and Materials of Construction Contribute Elemental Impurities to Packaged Pharmaceutical Drug Products
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Sep 2018, pdajpst.2018.008938; DOI: 10.5731/pdajpst.2018.008938
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  • Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: An Updated Literature Review
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Keywords

  • ICH Q3D
  • USP <232>
  • extractable elements
  • packaging

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