Leachables

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Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
Michael Ronk, Yasser Nashed-Samuel, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li and Hans Lee

PDA Journal of Pharmaceutical Science and Technology July 2020, pdajpst.2019.011379; DOI: https://doi.org/10.5731/pdajpst.2019.011379
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Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: An Updated Literature Review
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 324-347; DOI: https://doi.org/10.5731/pdajpst.2019.010033
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Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 348-358; DOI: https://doi.org/10.5731/pdajpst.2019.010520
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Identification and Quantitation Classifications for Extractables and Leachables
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 275-285; DOI: https://doi.org/10.5731/pdajpst.2019.010538
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Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation
Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 108-133; DOI: https://doi.org/10.5731/pdajpst.2018.009779
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Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 3—Considering Errors of Implementation and the Use of a Database to Judge and Promote Good Science and Efficient Practices
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 134-146; DOI: https://doi.org/10.5731/pdajpst.2018.009787
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Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission
Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 90-107; DOI: https://doi.org/10.5731/pdajpst.2018.009761
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Comparative Leachable Study of Glass Vials to Demonstrate the Impact of Low Fill Volume
Bernhard Hladik, Florence Buscke, Robert Frost and Uwe Rothhaar

PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 345-355; DOI: https://doi.org/10.5731/pdajpst.2018.009472
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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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Parenteral Drug Association, Inc.