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 …

Abstract Structure elucidation and quantitation of leachable impurities in pharmaceutical and
medical products are crucial because unidentified and potentially toxic leachable impurities …

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 …

Substances leached from pharmaceutical manufacturing systems, packages, and/or medical
devices can be administered to a patient during a clinical therapy and can adversely affect …

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 …

Full article: Guidelines for the Design, Implementation, and Interpretation of Validations for
Chromatographic Methods used to Quantitate Leachables/Extractables in Pharmaceutical …

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 …

Substances leached from materials used in pharmaceutical manufacturing systems,
packages, and/or medical devices can be administered to a patient as part of a clinical …

Pharmaceutical drug products (DP) can contain foreign impurities due to contact with
manufacturing, storage, distribution and administration systems. These foreign impurities …

Leachables and extractables are one of the most important reasons for drug product quality
deterioration and degradation. These components tend to migrate from the interior regions …