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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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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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  • 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
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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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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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