Leachables

You have access
Is Retention Time and/or Structure Matching a Solution to the Challenge of Providing Quantitative Data When Screening for Extractables and Leachables by GC/MS?
Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten and Jean-Marie Beusen

PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 236-247; DOI: https://doi.org/10.5731/pdajpst.2021.012673
You have access
Principles for Management of Extractables and Leachables in Ophthalmic Drug Products
Christopher T. Houston, Andrea Desantis Rodrigues, Brenda Birkestrand Smith, Tao Wang and Mary Richardson

PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 278-294; DOI: https://doi.org/10.5731/pdajpst.2022.012744
You have access
Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTC) Relevant to Parenteral Extractables and Leachables (E&Ls)
Melisa J. Masuda-Herrera, Joel P. Bercu, Thomas H. Broschard, Anders Burild, Catrin Hasselgren, Patricia Parris, Lucie C. Ford, Jessica Graham, Brad Stanard, Michele Comerford, Daniel Lettiere, Steffen Erler, Courtney M. Callis, Eric Morinello, Wolfgang Muster, Elizabeth A. Martin, Troy R. Griffin, Lee Nagao and Maureen Cruz

PDA Journal of Pharmaceutical Science and Technology January 2022, pdajpst.2021.012693; DOI: https://doi.org/10.5731/pdajpst.2021.012693
You have access
A Safety Risk-Based Extractables and/or Leachables Qualification Strategy for Packaged Drug Products
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 506-535; DOI: https://doi.org/10.5731/pdajpst.2020.012617
You have access
The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation
Dennis Jenke and Ted Heise

PDA Journal of Pharmaceutical Science and Technology May 2021, 75 (3) 273-288; DOI: https://doi.org/10.5731/pdajpst.2020.012013
You have access
An Analytical Strategy Based on Multiple Complementary and Orthogonal Chromatographic and Detection Methods (Multidetector Approach) to Effectively Manage the Analytical Evaluation Threshold (AET)
Mark Jordi and Ted Heise

PDA Journal of Pharmaceutical Science and Technology May 2021, 75 (3) 289-301; DOI: https://doi.org/10.5731/pdajpst.2020.012047
You have access
Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel

PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379
You have access
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
You have access
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
You have access
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

Main menu

User menu

Search

Leachables

Pages

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.