Leachable methods are typically far more challenging to develop than extractables due to the increased complexity from excipients and Active Pharmaceutical ingredients. This is coupled to the importance of leachables as these are the chemical species that the patient is exposed to and so the regulators are more concerned about the accuracy of these results. The presentation will cover aspects around the study design for leachables to enable correlation with extractables but also have enough information to generate a leachable specification if required.