Extractables and leachables (E&L) have become a focal point in pharmaceutical quality assurance due to their potential impact on drug safety and efficacy. Extractables are chemical entities that can ...

Not long ago, the assessment of extractables and leachables in drug products was performed mainly during late-phase research. Recently, regulators have been increasingly asking for additional E&L ...

Extractables and Leachables (E&L) testing is a crucial process in the development and manufacturing of pharmaceutical packaging and medical devices. Contrary to many other methods of laboratory ...

The article provides a detailed overview of the process used to determine leachables and extractables from plastics. This process is mostly preferred for plastics employed in food contact applications ...

DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/25jkl3/leachables_and_ext) has announced the addition of John Wiley and Sons ...

Drug manufacturers spend significant amount of time and money in characterizing, identifying, minimizing the impurities in a drug product so that regulatory bodies make accurate decisions with respect ...

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, talks to Piet Christiaens, PhD, scientific director, E&L expert at ...

The regulatory requirements concerning the control of Extractables and Leachables (E&L) in pharmaceutical products are becoming more and more stringent. The European Pharmacopoeia has recently ...

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach. Dujuan Lu, PhD, manager and global lead of the ...

The FDA industry guidance for container-closure systems for packaging human drugs and biologics requires the testing of container closure components for extractable leachable for all injectibles.

Each supplier of single-use technology products has an implicit obligation to characterize the materials of construction used in the manufacture of its products and to share that information with its ...