Extractables

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A Means of Establishing and Justifying Binary Ethanol/Water Mixtures as Simulating Solvents in Extractables Studies
Dennis Jenke, Norman Liu, Yousheng Hua, Steven Swanson and Roy Bogseth

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 366-382; DOI: https://doi.org/10.5731/pdajpst.2015.01046
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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
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Extractables Analysis of Single-Use Flexible Plastic Biocontainers
Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel

PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001
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A Compilation of Safety Impact Information for Extractables Associated with Materials Used in Pharmaceutical Packaging, Delivery, Administration, and Manufacturing Systems
Dennis Jenke and Tage Carlson

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 407-455; DOI: https://doi.org/10.5731/pdajpst.2014.00995
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Analysis and Evaluation of Single-Use Bag Extractables for Validation in Biopharmaceutical Applications
Ina Pahl, Samuel Dorey, Magali Barbaroux, Bertille Lagrange and Heike Frankl

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 456-471; DOI: https://doi.org/10.5731/pdajpst.2014.00996
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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
Steven A. Zdravkovic, Matthew D. Bruss, Robert F. Piccoli and Derek M. Wood

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 504-526; DOI: https://doi.org/10.5731/pdajpst.2014.00992
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A New Glass Option for Parenteral Packaging
Robert A. Schaut, John S. Peanasky, Steven E. DeMartino and Susan L. Schiefelbein

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 527-534; DOI: https://doi.org/10.5731/pdajpst.2014.00998
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The Use of TOC Reconciliation as a Means of Establishing the Degree to Which Chromatographic Screening of Plastic Material Extracts for Organic Extractables Is Complete
Dennis Jenke, Thomas R. Couch, Sarah J. Robinson, Trent J. Volz and Raymond H. Colton

PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 256-270; DOI: https://doi.org/10.5731/pdajpst.2014.00977
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Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products
Daniel L. Norwood, Lee M. Nagao and Cheryl L. M. Stults

PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 413-429; DOI: https://doi.org/10.5731/pdajpst.2013.00934
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The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood and Ingrid Markovic

PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 430-447; DOI: https://doi.org/10.5731/pdajpst.2013.00936

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Parenteral Drug Association, Inc.