It is generally acknowledged that quantitation in extractables and leachables (E&L) can be
variably reproducible and accurate, depending on the quantitation approach taken. This is …

The analytical evaluation threshold (AET) establishes which chromatographic peaks,
produced during organic extractables/leachables (E&L) screening, require toxicological …

A drug product is chromatographically screened for organic leachables, derived from the
product's packaging system, as leachables might adversely impact the health of a patient to …

Abstract Characterization of Extractables and Leachables (E&Ls) is an important aspect of
product quality in important fields such as pharmaceuticals, medical devices and food …

Extractables and leachables (E&L) are identified and quantified so that their impact on
patient safety can be established and assessed. The uncertainty in the impact assessment is …

Organic extractables and leachables (E&L) from drug product packaging, manufacturing
components, and delivery devices are of concern as they could impact product quality …

Substances from packaging systems that are leached into packaged medical products may
have a safety impact on patients to whom such medical products are administered. The …

Drug products and medical devices can contain leachable impurities that could adversely
affect patient health during their clinical use. To establish patient exposure to leachables …

This commentary considers the standardization of analytical methods used in extractables
and leachables screening and proposes that method standardization is not the end goal but …

Patients can be exposed to leachables derived from pharmaceutical manufacturing systems,
packages, and/or medical devices during a clinical therapy. These leachables can adversely …