Extractables and Leachables (E&L) Testing

Introduction Evaluating Process Equipment-Related Leachables (PERLs) under 21 CFR 211.65 is an essential compliance requirement for pharmaceutical and biopharmaceutical manufacturers […]

Introduction The USP Risk Assessment Explained framework provides biopharmaceutical manufacturers with a standardized, science-based methodology for classifying polymeric manufacturing components

Introduction: Extractables and Leachables in Lyophilized Drug Products are important pharmaceutical quality considerations because chemical substances originating from packaging and

Introduction: TTC in Extractables and Leachables (E&L) provides an exposure-based approach for evaluating potential toxicological concerns from low-level chemical substances

Introduction Extractables and Leachables Testing for Peptide Injectables is an essential analytical prerequisite for assessing the chemical compatibility, physical stability,

Introduction: Silicone Lubricant Leachables are chemical substances that can migrate from silicone-lubricated components of a pharmaceutical container or drug-delivery system

Introduction: Generic injectable manufacturers face a unique quality challenge: unlike oral or topical products, injectables can expose patients directly to

Introduction: USP <1663> and <1664> E&L Testing is the analytical backbone that connects a packaging or delivery-system material to a

Introduction Single-Use Systems and GMP Extractables and Leachables (E&L) Testing establishes the analytical foundation necessary for detecting, identifying, quantifying, and