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

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 …

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 …

To address patient safety, a drug product is chromatographically screened for organic
leachables. Similarly, medical device and packaging system extracts are …

The proposed safety thresholds for patient exposure to individual organic leachables in
orally inhaled and nasal drug products (OINDPs, or “inhalation drug products”), the …

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 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 …

Leachables are substances that are leached from a medical device during its clinical use
and are important due to the patient health-related effects they may have. Thus, medical …