Leachables from plastic materials in contact with drugs. State of the art and review of current analytical approaches
L Cuadros-Rodríguez, M Lazúen-Muros… - International Journal of …, 2020 - Elsevier
The plastics used in drug packaging systems and medical devices are composed of
homologous polymers and generally contain additives such as antioxidants, plasticizers and …
homologous polymers and generally contain additives such as antioxidants, plasticizers and …
New studies on leachables in commercial scale protein drug filling lines using stir bar sorptive extraction coupled with TD-GC–MS and UPLC/QTOF-MS/MS analytics
N Scherer, K Marcseková, T Posset, G Winter - International Journal of …, 2019 - Elsevier
The increasing application of Single-Use Systems (SUSs) in pharmaceutical manufacturing
lines poses a potential risk of polymer-related impurities leaching into the process stream …
lines poses a potential risk of polymer-related impurities leaching into the process stream …
Testing the Critical Interface: Leachables and Extractables.
MP Balogh, D Kiehl - LC-GC Europe, 2011 - search.ebscohost.com
The article studies the obstacles encountered when examining leachables and extractables
from packaging materials. It discusses leachable testing and routine testing for extractables …
from packaging materials. It discusses leachable testing and routine testing for extractables …
Pharmaceutical container closure systems: selection and qualification of materials
DJ Ball, WP Beierschmitt… - … and extractables handbook …, 2012 - Wiley Online Library
218 CHAPTER 12 PHARMACEUTICAL CONTAINER CLOSURE SYSTEMS several years
ahead of the projected commercial marketing date. Most drug product manufacturers desire …
ahead of the projected commercial marketing date. Most drug product manufacturers desire …
12.1 SELECTION, CHARACTERIZATION, AND APPROPRIATE ANALYTICAL TESTING OF MATERIALS FOR THE CONTAINER CLOSURE SYSTEM (CCS): THE …
DJ Ball, WP Beierschmitt, AJ Shaw - … and Extractables Handbook …, 2012 - books.google.com
A packaging system for a drug product is often one of the last items on a checklist for
companies involved with development of a new drug product; however, if speed to market is …
companies involved with development of a new drug product; however, if speed to market is …