Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review

Dennis R. Jenke; Cheryl L. M. Stults; Diane M. Paskiet; Douglas J. Ball; Lee M. Nagao

doi:10.5731/pdajpst.2015.01005

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Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review

Dennis R. Jenke, Cheryl L. M. Stults, Diane M. Paskiet, Douglas J. Ball and Lee M. Nagao

PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 1-48; DOI: https://doi.org/10.5731/pdajpst.2015.01005

Dennis R. Jenke

1Baxter Healthcare Corporation, Round Lake, IL;

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For correspondence: dennis_jenke@baxter.com

Cheryl L. M. Stults

2Novartis Pharmaceuticals Corporation, San Carlos, CA;

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Diane M. Paskiet

3West Pharmaceutical Services, Exton, PA;

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Douglas J. Ball

4Pfizer, Inc., Groton, CT; and

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Lee M. Nagao

5Drinker Biddle and Reath, LLP, Washington, DC

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vol. 69 no. 1 1-48

DOI

https://doi.org/10.5731/pdajpst.2015.01005

PubMed

25691713

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online February 17, 2015.

Author Information

Dennis R. Jenke1,*,
Cheryl L. M. Stults2,
Diane M. Paskiet3,
Douglas J. Ball4 and
Lee M. Nagao5

¹Baxter Healthcare Corporation, Round Lake, IL;
²Novartis Pharmaceuticals Corporation, San Carlos, CA;
³West Pharmaceutical Services, Exton, PA;
⁴Pfizer, Inc., Groton, CT; and
⁵Drinker Biddle and Reath, LLP, Washington, DC

↵*Corresponding Author: Dennis R. Jenke, Baxter Healthcare Corporation, 25212 W. Illinois Route 120, Round Lake, IL, 60073. e-mail: dennis_jenke{at}baxter.com

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Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review

Dennis R. Jenke, Cheryl L. M. Stults, Diane M. Paskiet, Douglas J. Ball, Lee M. Nagao

PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 1-48; DOI: 10.5731/pdajpst.2015.01005

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Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review

Dennis R. Jenke, Cheryl L. M. Stults, Diane M. Paskiet, Douglas J. Ball, Lee M. Nagao

PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 1-48; DOI: 10.5731/pdajpst.2015.01005

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Keywords

Elemental impurities
Polymers
Pharmaceutical manufacturing systems
Packaging systems
Extractables
Leachables

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