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
Research ArticlePQRI Special Section

Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products

Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933
Dennis Jenke
1Baxter Healthcare Corporation, Round Lake, IL, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: dennis_jenke{at}baxter.com
James Castner
2Pharma Interface Analysis, LLC, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Thomas Egert
3Boehringer Ingelheim Pharmaceuticals, Inc., Ingelheim/Rhein, Germany;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Tom Feinberg
4Catalent Pharma Solutions, Morrisville, NC, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Alan Hendricker
4Catalent Pharma Solutions, Morrisville, NC, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Christopher Houston
5Bausch & Lomb, Rochester, NY, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Desmond G. Hunt
6United States Pharmacopoeia, Rockville, MD, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Michael Lynch
7Pfizer, Groton, CT, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Arthur Shaw
7Pfizer, Groton, CT, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Kumudini Nicholas
8Bureau of Pharmaceutical Sciences, Health Canada, Ottawa, ON, Canada;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Daniel L. Norwood
9Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Diane Paskiet
10West Pharmaceutical Services, Exton PA, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Michael Ruberto
11Materials Needs Consulting LLC, Montvale, NJ, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Edward J. Smith
12Packaging Science Resources, King of Prussia, PA, USA; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Frank Holcomb
13United States Food and Drug Administration, Washington, DC, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

Article Information

vol. 67 no. 5 448-511
DOI 
https://doi.org/10.5731/pdajpst.2013.00933
PubMed 
24084660

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 1, 2013.

Copyright & Usage 
© PDA, Inc. 2013

Author Information

  1. Dennis Jenke1,*,
  2. James Castner2,
  3. Thomas Egert3,
  4. Tom Feinberg4,
  5. Alan Hendricker4,
  6. Christopher Houston5,
  7. Desmond G. Hunt6,
  8. Michael Lynch7,
  9. Arthur Shaw7,
  10. Kumudini Nicholas8,
  11. Daniel L. Norwood9,
  12. Diane Paskiet10,
  13. Michael Ruberto11,
  14. Edward J. Smith12 and
  15. Frank Holcomb13
  1. 1Baxter Healthcare Corporation, Round Lake, IL, USA;
  2. 2Pharma Interface Analysis, LLC, USA;
  3. 3Boehringer Ingelheim Pharmaceuticals, Inc., Ingelheim/Rhein, Germany;
  4. 4Catalent Pharma Solutions, Morrisville, NC, USA;
  5. 5Bausch & Lomb, Rochester, NY, USA;
  6. 6United States Pharmacopoeia, Rockville, MD, USA;
  7. 7Pfizer, Groton, CT, USA;
  8. 8Bureau of Pharmaceutical Sciences, Health Canada, Ottawa, ON, Canada;
  9. 9Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA;
  10. 10West Pharmaceutical Services, Exton PA, USA;
  11. 11Materials Needs Consulting LLC, Montvale, NJ, USA;
  12. 12Packaging Science Resources, King of Prussia, PA, USA; and
  13. 13United States Food and Drug Administration, Washington, DC, USA
  1. ↵*Corresponding Author: Dennis Jenke, Baxter Healthcare Corporation, 25212 West Illinois Route 120, Round Lake, IL 60047. dennis_jenke{at}baxter.com
View Full Text

Cited By...

  • Citations
  • Google Scholar

This article has not yet been cited by articles in journals that are participating in Crossref Cited-by Linking.

PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 67 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 5
September/October 2013
  • Table of Contents
  • Index by Author
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.
Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
(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.
8 + 5 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb
PDA Journal of Pharmaceutical Science and Technology Sep 2013, 67 (5) 448-511; DOI: 10.5731/pdajpst.2013.00933

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb
PDA Journal of Pharmaceutical Science and Technology Sep 2013, 67 (5) 448-511; DOI: 10.5731/pdajpst.2013.00933
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Experimental
    • Test Materials and Their Extractables Profiles
    • Discussion
    • Footnotes
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Comparison of Binary Alcohol/Water Solvent Systems to Blood for Extractions of Blood-Contacting Medical Devices
  • Science- and risk-based strategy to qualify prefillable autoclavable syringes as primary packaging material
  • Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)
  • Principles for Management of Extractables and Leachables in Ophthalmic Drug Products
  • Assessment of Extractable Elements from Elastomers
  • Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
  • A Method Utilizing Ultra-High Performance Liquid Chromatography with Ultraviolet and Mass Spectrometric Detection for the Analysis of Material Extracts Produced during a Controlled Extraction Study
  • Google Scholar

More in this TOC Section

PQRI Special Section

  • The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
  • Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products
Show more PQRI Special Section

Research

  • Assessment of the Microbiological Quality of a Preservative-Free Multidose System following a Mixed Culture Microbial Immersion Challenge
  • Roadmap to Implementation of a Rapid “Lab in a Pouch” NAT Method for Mycoplasma Testing
  • An Assessment of Pyrexia, Patient Age and Weight; Pediatric Considerations
Show more Research

Similar Articles

Keywords

  • Extractables
  • Leachables
  • Plasticized poly (vinyl chloride)
  • Polycarbonate
  • Low-density polyethylene
  • Rubber
  • Cyclic olefin copolymer
  • Polymer analysis

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