The Dissolution Methods Database has been prepared by the Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration. The dissolution methods contained in the database are recommended methods that are not binding on FDA or others. We will consider alternate methods when supported by appropriate data. We recognize that the database contains a large amount of material, and methods and specifications may change over time. We welcome comments or suggested changes to the database. We plan to revise the web site on an ongoing basis.
Please send suggested changes to this database, along with supporting documentation to: