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Article CommentaryCommentary

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 March 2019, 73 (2) 181-190; DOI: https://doi.org/10.5731/pdajpst.2018.008938
Dennis Jenke
Triad Scientific Solutions, LLC, Hawthorn Woods, IL, USA
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Article Information

vol. 73 no. 2 181-190
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 
  • Published online April 8, 2019.

Article Versions

  • previous version (September 19, 2018 - 09:44).
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Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Dennis Jenke*
  1. Triad Scientific Solutions, LLC, Hawthorn Woods, IL, USA
  1. ↵* Corresponding Author: Triad Scientific Solutions, LLC, 181 Peregrine Lane, Hawthorn Woods, IL 60047; e-mail: dennisjenke{at}triadscientificsolutions.com
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PDA Journal of Pharmaceutical Science and Technology: 73 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 2
March/April 2019
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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 Mar 2019, 73 (2) 181-190; 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 Mar 2019, 73 (2) 181-190; DOI: 10.5731/pdajpst.2018.008938
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  • Article
    • Abstract
    • Introduction
    • The Mandate for Testing Container Closure Systems and Their Materials of Construction To Establish Their Contribution of Elemental Impurities To Packaged Drug Products
    • Testing Container Closure Systems To Establish Their Ability To Contribute Elemental Impurities To Packaged Drug Products
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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

  • Elemental impurities
  • Extracted elements
  • packaging
  • ICH Q3D
  • USP <232>

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