Type of Posting: Notice of Intent to Revise
Posting Date: 28-Feb-2025
Targeted Official Date: 01-Nov-2025; 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 Nefazodone Hydrochloride monograph.
The Expert Committee proposes to revise the Nefazodone Hydrochloride monograph to replace USP Nefazodone Related Compound A RS with USP Trazodone Related Compound F RS.
Other updates are made to the monograph as follows:
- Update the chemical name of Nefazodone Hydrochloride in the chemical information section.
- Add flexibility to the Identification–A test.
- Add a Sensitivity solution to support a new signal-to-noise ratio system suitability requirement to verify adequate chromatographic system sensitivity.
- Update System Suitability section within the test for Organic Impurities.
- Add a table and Note to the System suitability section within the test for Organic impurities to present Relative Retention Times as an aid in peak assignment.
- Revise the table in the Acceptance criteria section to list only the limits for specified impurities, Any unspecified impurity, and Total impurities.
- Update the USP Reference Standards <11> section to reflect current chemical information.
Additional changes to align the monograph with current USP style are also proposed.
It is anticipated that the proposed revision will be published as an Interim Revision Announcement in Pharmacopeial Forum 51(3) [May.–Jun. 2025] pursuant to the Rules and Procedures. The comment period for this revision ends on July 31, 2025. In the absence of any adverse comments, the proposed IRA will become official on November 1, 2025.
Should you have any questions, please contact Rajitha Radhakrishnan, Senior Scientist I (rajitha.radhakrishnan@usp.org).