A consideration of the impact of solution composition on the accumulation of organic substances leached from plastics used in container/closure systems

D Jenke, T Couch - PDA Journal of Pharmaceutical Science and …, 2006 - journal.pda.org
A multi-layered, laminated plastic material, similar to those used in flexible intravenous
solution containers, was loaded to contain known amounts of 15 model compounds whose …

Accumulation of organic compounds leached from plastic materials used in biopharmaceutical process containers

DR Jenke, D Zietlow, MJ Garber, S Sadain… - PDA Journal of …, 2007 - journal.pda.org
Plastic materials are widely used in medical items, such as solution containers, transfusion
sets, transfer tubing, and devices. An emerging trend in the biotechnology industry is the …

Accumulation of extractables in buffer solutions from a polyolefin plastic container

DR Jenke, JM Jene, M Poss, J Story… - International journal of …, 2005 - Elsevier
Plastic materials are widely used in medical items, such as solution containers, transfusion
sets, transfer tubing and devices. An emerging trend in the biotechnology industry is the …

A general assessment of the physiochemical factors that influence leachables accumulation in pharmaceutical drug products and related solutions

D Jenke - PDA journal of pharmaceutical science and technology, 2011 - journal.pda.org
The accumulation of organic compounds associated with plastic materials into
pharmaceutical products and their associated solutions has important suitability for use …

The effect of solvent polarity on the accumulation of leachables from pharmaceutical product containers

D Jenke, A Odufu, M Poss - European journal of pharmaceutical sciences, 2006 - Elsevier
Material/water equilibrium interaction constants (Eb) were determined for 12 organic model
solutes and a plastic material used in pharmaceutical product containers (non-PVC …

Extractables/leachables from plastic tubing used in product manufacturing

DR Jenke, J Story, R Lalani - International Journal of Pharmaceutics, 2006 - Elsevier
While the ability of packaging systems to contribute leached substances to finished drug
products is well established, increasing interest is being focused on the potential …

Modeling of the leachables impact on the engineering of parenteral product container systems

DR Jenke, EK Chess, G Jakubowski - International journal of pharmaceutics, 1994 - Elsevier
This study examines the impact, from a leachables perspective, of charging a solution
contact component of a polymeric solution container. By charging such a container …

Evaluation of model solvent systems for assessing the accumulation of container extractables in drug formulations

DR Jenke - International journal of pharmaceutics, 2001 - Elsevier
The interaction between a medical device and a pharmaceutical solution it contacts may
dictate solution safety and/or efficacy. Of specific concern is the ability of device components …

Organic extractables from packaging materials: Chromatographic methods used for identification and quantification

D Jenke - Journal of liquid chromatography & related …, 2003 - Taylor & Francis
A review is provided, related to the chromatographic methods used to assess the
accumulation of leachable substances from packaging materials used for pharmaceutical …

Validation of a liquid chromatographic method for quantitation of organic compounds leached from a plastic container into a pharmaceutical formulation

D Jenke, M Jo Garber, D Zietlow - Journal of liquid chromatography …, 2005 - Taylor & Francis
Full article: Validation of a Liquid Chromatographic Method for Quantitation of Organic
Compounds Leached from a Plastic Container into a Pharmaceutical Formulation Skip to …