Dennis Jenke

Quantitative Aspects of Non-targeted Analysis for Organic Extractables/Leachables; Insights Secured by Considering the FDA CLAP List Compounds

Substances released from a drug product’s manufacturing, packaging, and delivery system are termed leachables. Medical device leachables are released during their clinical use. Packaged drug products and medical devices are profiled for leachables (and/or extractables as probable...