The USP Dissolution Methods Database contains the test conditions (except Tolerances or Acceptance Criteria) as stated in the sections referring to dissolution, disintegration, or drug release tests in the respective USP drug product monograph. This information will be updated when a new edition of USP, including its supplements, becomes available to the public. This database does not contain information from Revision Bulletins that have not been incorporated in the official text of USP. For that information, please visit our Revision Bulletins webpage.
Application & Use
The database allows you to search by (via drop-down lists):
- Monograph name
- Dissolution medium: composition, surfactant (if used), pH, volume, and deaeration (if used)
- Apparatus: type and rotation speed, dip rate, or flow rate
- Duration of the test
- Analytical finish
- Exceptions: any additional information not covered by the previous items such as type of sinker, use of special software, use of a wavelength other than the one for maximum absorbance, etc.
It is a useful tool to answer questions such as:
- Which USP monograph calls for the use of USP Apparatus 4 (flow-through cell) for dissolution test?
- Which USP monographs calls for the use of USP apparatus 3 (reciprocating cylinder)?
- Are there any dissolution methods that require a dissolution medium with pH above 9?
- Where can the preparation of a particular dissolution medium be found?
(last updated June, 8 2017)
- FDA Dissolution Methods Database: For drug products that do not have a USP dissolution test method, the FDA provides information on dissolution methods presently recommended by the Division of Bioequivalence, Office of Generic Drugs.
- Dissolution Technologies: Journal dedicated to dissolution, disintegration, and drug release tests and their applications.
- <711> Dissolution FAQs
- <1092> Dissolution Procedure: Development and Validation FAQs
- Database questions? Please email firstname.lastname@example.org.