Type of Posting: Notice of Intent to Revise
Posting Date: 25-Apr-2025
Targeted Official Date: 01-Jan-2026; Interim Revision Announcement
Expert Committee: Small Molecules 4
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 4 Expert Committee intends to revise the Desvenlafaxine Succinate monograph.
Comments with supporting data were received that indicate the Relative Response Factors in the test for Organic Impurities are not correct. It was found that the current values were determined against the free base while there is no molecular weight conversion in the impurity’s calculation. The Expert Committee proposes to revise the Relative Response Factors to be against Desvenlafaxine Succinate, the salt, in the test for Organic impurities of Desvenlafaxine Succinate monograph. Stakeholders are encouraged to provide specific requests as well as supporting data for the Expert Committee’s consideration.
It is anticipated that the proposed revision will be published as an Interim Revision Announcement (IRA) in Pharmacopeial Forum 51(4) pursuant to the Rules and Procedures. In the absence of adverse comments, the revision will become official January 1, 2026.
Should you have any questions, please contact Yanyin Yang, Senior Scientist II (yanyin.yang@usp.org).