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Article CommentaryCommentary

Accurate or Protective: What Is the Goal of Non-Targeted Extractables and Leachables Quantitation and Identification?

Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 358-366; DOI: https://doi.org/10.5731/pdajpst.2023.012868
Dennis Jenke
Triad Scientific Solutions, Peregrine Lane, Hawthorn Woods, Il 60047 USA
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Article Information

vol. 78 no. 3 358-366
DOI 
https://doi.org/10.5731/pdajpst.2023.012868
PubMed 
37973191

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online June 28, 2024.

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  • previous version (November 16, 2023 - 04:45).
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© PDA, Inc. 2024

Author Information

  1. Dennis Jenke*
  1. Triad Scientific Solutions, Peregrine Lane, Hawthorn Woods, Il 60047 USA
  1. ↵* Corresponding Author: Peregrine Lane, Hawthorn Woods, IL 60047 USA E-mail: dennisjenke{at}triadscientificsolutions.com
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PDA Journal of Pharmaceutical Science and Technology: 78 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 3
May/June 2024
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Accurate or Protective: What Is the Goal of Non-Targeted Extractables and Leachables Quantitation and Identification?
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 358-366; DOI: 10.5731/pdajpst.2023.012868

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Accurate or Protective: What Is the Goal of Non-Targeted Extractables and Leachables Quantitation and Identification?
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 358-366; DOI: 10.5731/pdajpst.2023.012868
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  • Article
    • Abstract
    • Introduction
    • Accuracy versus Protection
    • Quantitation
    • Identification
    • The Downside of Excessive Protectives (Excessive Overestimation)
    • Conclusions
    • Conflict of Interest Declaration
    • References
  • Figures & Data
  • References
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Cited By...

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  • Correlating GC/MS Relative Response Factors to Analytes Physicochemical and Chromatographic Properties to Facilitate the Quantitation of Organic Extractables and Leachables in Non-Targeted Analysis (NTA). Concepts and Empirical Considerations
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Keywords

  • Extractables
  • Leachables
  • Quantitation
  • Identification
  • Accuracy
  • Protection

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