Extractables / leachables with plastic components

The stability evaluation of nasal solutions and suspensions equipped with a metering pump should include appearance, color, clarity, assay, degradation products, preservative and antioxidant content, microbial limits, pH, particulate matter, unit spray medication content uniformity, number of actuations meeting unit spray content uniformity per container, droplet or particle size distribution, weight loss, pump delivery, microscopic evaluation (for suspensions), foreign particulate matter, and extractables and leachables from plastic and elastomeric components of the container, closure, and pump. 

Testing for extractables and leachables on stability studies may be appropriate in situations where other qualification tests have not provided sufficient information or assurance concerning the levels of extractables and leachables from plastics and elastomeric components. Interaction of administration sets and dispensing devices with parenteral drug products, where warranted, should also be considered through appropriate use test protocols to ensure that absorption and adsorption during dwell time do not occur. 

Removal of extractables from an elastomer or plastic matrix can be accomplished by a variety of techniques, including solvent extraction (e.g., reflux and Soxhlet), supercritical fluid extraction, thermal evolution, etc. Jenke has thoroughly discussed and classified extraction strategies for container closure system components associated with a drug product leachables assessment. His discussion is based on two so-called directives paraphrased as follows ... 

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