Leachables

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Comparison of a Lyophilized Drug Product to Other Solid and Liquid Media for the Extraction of Elastomeric Oligomers from a Butyl Rubber Stopper
Steven A. Zdravkovic

PDA Journal of Pharmaceutical Science and Technology November 2017, 71 (6) 488-501; DOI: https://doi.org/10.5731/pdajpst.2016.007468
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Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic

PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229
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A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
Nina J. Xiao, Colin D. Medley, Ian C. Shieh, Gregory Downing, Shelly Pizarro, Jun Liu and Ankit R. Patel

PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 533-546; DOI: https://doi.org/10.5731/pdajpst.2015.006338
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Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products
Kim Li, Gary Rogers, Yasser Nashed-Samuel, Hans Lee, Anthony Mire-Sluis, Barry Cherney, Ronald Forster, Ping Yeh and Ingrid Markovic

PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 590-619; DOI: https://doi.org/10.5731/pdajpst.2015.01073
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PDA Single-Use Systems Cross-Organizational Workshop—Meeting Summary, May 14, 2014—PDA Global Headquarters, Bethesda, MD
Robert Repetto and Richard Levy

PDA Journal of Pharmaceutical Science and Technology March 2015, 69 (2) 317-325; DOI: https://doi.org/10.5731/pdajpst.2015.01048
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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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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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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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Parenteral Drug Association, Inc.