Regulators require drug product manufacturers to identify and quantify extractables and leachables so that their impact on patient safety and product quality can be assessed. At PharmSky, we provide analytical services to assess extractables of a material through controlled extraction studies and assess leachables in drug products by performing migration studies. Regardless of the phase of drug development, PharmSky can assist clients with E&L studies to support product registration.
PharmSky’s E&L Services
Risk Assessment
PharmSky can assist clients to review manufacturing process components, container closure systems and/or device materials for extractables and leachables and identify high risk components for potential leaching. Recommendations can be suggested to replace high risk materials or components with more suitable alternatives to reduce risk.
Strategy and Study Design
Design E&L studies specific to the product, taking into consideration the risk assessment, dosage form, route of administration, dose frequency and duration, drug formulation and product contact materials. Feasibility studies may be conducted to determine sample preparation, extraction conditions, instrument capability and suitability of test methods.
Controlled Extraction Studies
Generate an extractables profile to determine material compatibility, assist with container closure selection and identify potential leachables for further toxicological assessment
Leachables (Migration) Studies
Assess the drug product for leachables at predefined time points over the product’s shelf life. In addition, PharmSky has dedicated GMP storage facilities to support E&L testing.
Impurity Identification
PharmSky is equipped with highly sensitive instruments (UPLC-QToF MS and GC-MS/MS) that provide accurate mass analysis for confident identification of unknowns.
