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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;
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  • For correspondence: dennis_jenke@baxter.com
James Castner
2Pharma Interface Analysis, LLC, USA;
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Thomas Egert
3Boehringer Ingelheim Pharmaceuticals, Inc., Ingelheim/Rhein, Germany;
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Tom Feinberg
4Catalent Pharma Solutions, Morrisville, NC, USA;
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Alan Hendricker
4Catalent Pharma Solutions, Morrisville, NC, USA;
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Christopher Houston
5Bausch & Lomb, Rochester, NY, USA;
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Desmond G. Hunt
6United States Pharmacopoeia, Rockville, MD, USA;
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Michael Lynch
7Pfizer, Groton, CT, USA;
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Arthur Shaw
7Pfizer, Groton, CT, USA;
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Kumudini Nicholas
8Bureau of Pharmaceutical Sciences, Health Canada, Ottawa, ON, Canada;
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Daniel L. Norwood
9Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA;
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Diane Paskiet
10West Pharmaceutical Services, Exton PA, USA;
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Michael Ruberto
11Materials Needs Consulting LLC, Montvale, NJ, USA;
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Edward J. Smith
12Packaging Science Resources, King of Prussia, PA, USA; and
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Frank Holcomb
13United States Food and Drug Administration, Washington, DC, USA
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  • Article
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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
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PDA Journal of Pharmaceutical Science and Technology: 67 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 5
September/October 2013
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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

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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
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Keywords

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

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