USP Releases Online Database of Dissolution Methods

Rockville, MD-December 16, 2015—The USP Dissolution Methods Database is now available online. The database contains the test conditions (except Tolerances or Acceptance Criteria) as stated in the sections of the United States Pharmacopeia—National Formulary ( USP-NF) referring to dissolution, disintegration, or drug release tests in the respective USP drug product monograph.

Information in the database will be updated when a new edition of USP-NF, 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-NF. For that information, please visit our Revision Bulletins webpage.

The database is available as a downloadable Excel file posted and updated on www.usp.org. It is searchable and sortable.

The database allows the user to search by:

• 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.

The USP Dissolution Methods Database is a useful tool to answer questions such as:

• Which USP monographs calls for the use of USP Apparatus 4 (flow-through cell) for dissolution test?
• Which USP monographs call 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?

For additional information on the USP Dissolution Methods Database, contact Margareth Marques at mrm@usp.org.

About USP

The U.S. Pharmacopeial Convention (USP) is a global health organization that improves lives through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP’s standards are used worldwide. For more information about USP, visit http://www.usp.org.