CORRELATING MATERIAL COMPOSITION TO EXTRACTABLES AND LEACHABLES

摘要

Packaged pharmaceutical drug products can interact with their container-closure systems, resulting in the migration of substances from the packaging and into the drug product. This is of concern due to the potential toxicity ahdZ-qr reactivity of the migrating substances. To properly assess the safety risk and manage the safety hazard posed by migratory substances, it is necessary to know the identities of the migratory substances and the magnitude of the patient exposure to such substances. The process by which migrating compounds are discovered, identified and quantified in a finished drug product is termed chemical assessment. Because the development of a finished drug product is a long and involved process, chemical assessment is typically a series of actions which include characterizing a system's materials of construction for their ingredients, qualifying the system by establishing its extractables and qualifying the drug product by quantifying its leachables. This manuscript considers the use of material characterization data (ingredients) for forecasting extractables and/or leachables profiles. So doing takes the mystery out of extractables and leachables profiling, facilitating both processes.