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Jan 02, 2019

Latest Research on Extraction/Leaching, Split-Cakes and More in Jan/Feb PDA Journal

Three new research articles in the January/February PDA Journal of Pharmaceutical Science and Technology address extraction/leaching, split-cakes and calculating random effects model tolerance intervals.


  • Denise Bohrer, et al., “Extraction/leaching of Metal Containing Additives from Polyvinyl Chloride, Ethyl Vinyl Acetate, and Polypropylene Bags and Infusion Sets into Infusion Solutions”
  • Philippe Lam and Thomas W. Patapoff, “Split-cakes, still delicious”
  • Richard O. Montes, Richard K. Burdick, and David J. LeBlond, “Simple Approach to Calculate Random Effects Model Tolerance Intervals to Set Release and Shelf-life Specification Limits of Pharmaceutical Products”


  • Diego Zurbriggen, et al., “Assessment of Extractable Elements from Elastomers”
  • Liang Fang and Cathy Zhao, “Modeling the Permeation Rates of Organic Migrants Through a Fluoropolymer Film”

Case Study

  • Xia Cathy Zhao, et al., “A Case Study to Address a Gap in the Device-to-Vial Interface Stopper Push-in by Chemo Spikes - An Overlooked Oncology Safety Risk”


  • Dennis Jenke, “How One Might Experimentally Determine if Container Closure Systems and their Components and Materials of Construction Contribute Elemental Impurities to Packaged Pharmaceutical Drug Products”


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