The dissolution methods included in the database reflect methods used for quality control testing in approved applications that have been previously found acceptable by the FDA, USP methods, and methods recommended in FDA guidance(s) (e.g., Guidance for Industry, Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances). These dissolution methods are not required to be used by applicants; FDA will consider alternate methods instead of those listed in the database, the acceptability of which will be determined based on whether the method is supported by appropriate data. It is important to note that the database contains a large amount of material, and methods and acceptance criterion/criteria may change over time. Methods used in more recently approved submissions may differ from methods currently reflected in the database. We welcome comments or suggested changes to the database. We plan to revise this web site on an ongoing basis.
Please send suggested changes to this database, along with supporting documentation to:
Division of Biopharmaceutics (HFD-003)
Office of New Drug Products
Office of Pharmaceutical Quality
10903 New Hampshire Ave
Silver Spring, MD 20993