2018 - Stability Programs for Leachable Impurities

Leachables are impurities which originate from contact surfaces (typically the final container/closure) of the drug product. As with drug product related impurities it is important to monitor the leachables over the shelf-life of the products to ensure patient safety. Performing leachable stability studies can be challenging and is generally less understood than for typical drug product related impurities. There are several key differences between leachables and drug product related impurities which must be understood in order to design an effective stability program.
This presentation will cover: what are leachables, where they come from, what are the similarities and differences in comparison with drug product related impurities and what are the method and stability requirements.