Extractable and Leachable Compounds

Click here to register for free and to view the entire webinar:

Speakers:

John Iannone, Program Manager – Extractables/Leachables & Special Studies, Toxikon Corporation

Karen Pieters, Project Manager – Extractables/Leachables, Toxikon Corporation

Anja Cerstiaens, Study Director Coordinator, Toxikon Corporation

The importance of extractable/leachable testing for container closure systems (CCS) in the pharmaceutical industry has grown considerably in the last few years, driven by well-documented incidents where impurities in the contained drug product – introduced by the container closure system via leaching – were found to be harmful to the patients, as well as an increase in global regulatory requirements associated with such concerns.

As a first step in the qualification of a container or closure from an E/L-perspective, a controlled extraction study must be performed to understand the associated extraction profile of that material. Apart from the technical issues in designing these extractable studies, it is of utmost importance to identify as many compounds as possible during a “First Pass” experiment. This is why Toxikon developed the TOX-RAY Screener Database, which allows to uniquely identify compounds, based upon the analysis of over 3500 actual standards. In addition, Toxikon has invested heavily in the high-end, state-of-the-art analytical techniques to further unravel the structure of some compounds that are not readily identified. These techniques can significantly contribute to further determine the chemical structure of a molecule.

Knowing the structure of a chemical compound is of high importance, even at the level of an extraction study, because it’s the chemical structure (a.o.) that will determine its toxicity. Toxikon developed a unique tool, called TOX-RITE (Rapid Initial Toxicological Evaluation) to allow a quick toxicological screening of the analytical results of an extraction study. This allows to rapidly identify which compounds should be monitored during the subsequent “formal” leachable study.