Want to know the dissolution and disintegration test conditions for a specific drug article and how they’re stated in their respective USP drug product monographs? Go to the USP Dissolution Methods Database.
Below are examples of search terms in the databases and the type of questions it will help you answer.
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 August, 2019)
- 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.