Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
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
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: dennisjenke@triadscientificsolutions.com
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    U.S. Pharmacopeial Convention, General Chapter <1665> Validation of Compendial Procedures. In USP 43—NF 38, USP: Rockville, MD, 2017; p 8166.
  2. 2.↵
    1. Jenke D.
    Standardization of Chromatographic Screening Methods for Organic Extractables and Leachables by Managing Outcomes. PDA J. Pharm. Sci. Technol. 2023, 77 (4), 329–338.
    OpenUrlAbstract/FREE Full Text
  3. 3.↵
    U.S. Pharmacopeial Convention, General Chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. In USP 43—NF 38, USP: Rockville, MD, 2020, p 8442.
  4. 4.↵
    1. Jenke D.,
    2. Christiaens P.,
    3. Verlinde P.,
    4. Baeten J.,
    5. Beusen J.-M.
    Is Retention Time and/or Structure Matching a Solution to the Challenge of Providing Quantitative Data When Screening for Extractables and Leachables by GC/MS? PDA J. Pharm. Sci. Technol. 2022, 76 (3), 236–247.
    OpenUrlAbstract/FREE Full Text
  5. 5.↵
    1. Jenke D.,
    2. Christiaens P.,
    3. Verlinde P.,
    4. Baeten J.,
    5. Beusen J.-M.
    A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation. PDA J. Pharm. Sci. Technol. 2022, 76 (3), 178–199.
    OpenUrlAbstract/FREE Full Text
  6. 6.↵
    1. Jordi M. A.,
    2. Khera S.,
    3. Roland K.,
    4. Jiang L.,
    5. Solomon P.,
    6. Nelson J.,
    7. Lateef S. S.,
    8. Woods J.,
    9. Martin L.,
    10. Martin S.,
    11. Aiello F.,
    12. Chen N.
    Qualitative Assessment of Extractables from Single-Use Components and the Impact of Reference Standard Selection. J. Pharm. Biomed. Anal. 2018, 150, 368–376.
    OpenUrl
  7. 7.↵
    International Organization for Standardization, ISO 10993-18:2020 Biological Evaluation of Medical Devices—Part 18: Chemical Characterization of Medical Device Materials Within a Risk Management Process. ISO: Geneva, 2020.
  8. 8.↵
    1. Christiaens P.,
    2. Beusen J.-M.,
    3. Verlinde P.,
    4. Baeten J.,
    5. Jenke D.
    Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2: The Errors of Inexact Identification and Inaccurate Quantitation. PDA J. Pharm. Sci. Technol. 2020, 74 (1), 108–133.
    OpenUrlAbstract/FREE Full Text
  9. 9.↵
    1. Jordi M. A.,
    2. Rowland K.,
    3. Liu W.,
    4. Cao X.,
    5. Zong J.,
    6. Ren Y.,
    7. Liang Z.,
    8. Zhou X.,
    9. Louis M.,
    10. Lerner K.
    Reducing Relative Response Factor Variation Using a Multidetector System for Extractables and Leachables (E&L) Analysis to Mitigate the Need for Uncertainty Factors. J. Pharm. Biomed. Anal. 2020, 186, 113334.
    OpenUrl
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 78 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 3
May/June 2024
  • Table of Contents
  • Index by Author
  • Complete Issue (PDF)
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Accurate or Protective: What Is the Goal of Non-Targeted Extractables and Leachables Quantitation and Identification?
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
4 + 9 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
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

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
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
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Accuracy versus Protection
    • Quantitation
    • Identification
    • The Downside of Excessive Protectives (Excessive Overestimation)
    • Conclusions
    • Conflict of Interest Declaration
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
  • 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
  • Google Scholar

More in this TOC Section

  • A Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters
  • Challenges and Solutions to Manufacturing of Low-Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill Finish Processing
  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review
Show more Commentary

Similar Articles

Keywords

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

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire