Strategy for determining extractables from rubber packaging materials in drug products
DM Paskiet - PDA Journal of Pharmaceutical Science and …, 1997 - journal.pda.org
The migration of substances from rubber packaging materials into drug products can be
significant with certain packaging materials in contact with organic solvent systems …
significant with certain packaging materials in contact with organic solvent systems …
How sterilization of primary packaging influences the results of E&L studies: as the demands that are being placed on the quality and stability of medications continue …
T Sogding, D Canton, D Haines, U Rothhaar - Contract Pharma, 2015 - go.gale.com
Even primary packaging that has been manufactured and stored properly can release
substances into the drug formulation. For this reason, pharmaceutical manufacturers are …
substances into the drug formulation. For this reason, pharmaceutical manufacturers are …
Comparison of the Levels of Rubber Stopper-Related Organic Leachables in Commercially Available Vialed Liquid and Lyophilized Drug Products
SA Zdravkovic - Pharmaceutical Research, 2020 - Springer
Purpose Rubber stoppers that seal the primary packaging systems of parenteral
pharmaceutical products have the potential to introduce impurities into the drug during …
pharmaceutical products have the potential to introduce impurities into the drug during …
Comparison of a lyophilized drug product to other solid and liquid media for the extraction of elastomeric oligomers from a butyl rubber stopper
SA Zdravkovic - PDA journal of pharmaceutical science and …, 2017 - journal.pda.org
Lyophilization is commonly used to extend the shelf life of pharmaceutical products that are
otherwise unstable when stored as a liquid formulation. However, the ability of a lyophilized …
otherwise unstable when stored as a liquid formulation. However, the ability of a lyophilized …
Structural identification of extractables from rubber closures used for pre-filled semisolid drug applicator by chromatography, mass spectrometry, and organic synthesis
F Zhang, A Chang, K Karaisz, R Feng, J Cai - Journal of pharmaceutical …, 2004 - Elsevier
Extractables or leachables from rubber closures used for drug products can potentially be
detrimental since some of these rubber extractables are known to be toxic and pyrogenic. In …
detrimental since some of these rubber extractables are known to be toxic and pyrogenic. In …
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 …
products is well established, increasing interest is being focused on the potential …
Identification of UV-absorbing extractables from rubber closures used in containers of injectable powder and safety assessment of leachables in the drug
Y Wei, Y Wu, T Zhu, Z Li, Y Zhang - Journal of Pharmaceutical and …, 2017 - Elsevier
Rubber closures have been of great concern to regulatory authorities on account of their
potential safety risks to patients. The aim of our work is to provide part of data about the …
potential safety risks to patients. The aim of our work is to provide part of data about the …
Controlled extraction studies applied to polyvinyl chloride and polyethylene materials: conclusions from the ELSIE controlled extraction pilot study
A Teasdale, M Jahn, S Bailey, A Feilden, G Taylor… - AAPS …, 2015 - Springer
The effective management of leachables in pharmaceutical products is a critical aspect of
their development. This can be facilitated if extractables information on the materials used in …
their development. This can be facilitated if extractables information on the materials used in …
A holistic approach of extractables and leachables assessment of rubber stoppered glass vial systems for biotechnology products
L Qi, J Liu, M Ronk, A Gallegos, K Fujimori… - Journal of …, 2021 - Elsevier
Rubber stoppered glass vial systems are widely used as primary containers for storing and
delivering therapeutic protein products to patients. Addressing concerns and regulatory …
delivering therapeutic protein products to patients. Addressing concerns and regulatory …
Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products
D Jenke, J Castner, T Egert, T Feinberg… - PDA Journal of …, 2013 - journal.pda.org
Polymeric and elastomeric materials are commonly encountered in medical devices and
packaging systems used to manufacture, store, deliver, and/or administer drug products …
packaging systems used to manufacture, store, deliver, and/or administer drug products …