Type of Posting: Notice of Intent to Revise
Posting Date: 23-Apr-2025; updated 24-Apr-2025
Targeted Official Date: 01-Aug-2026
Expert Committee: Non-Botanical Dietary Supplements
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Non-Botanical Dietary Supplements Expert Committee intends to revise Choline Bitartrate monograph.
Comments were received detailing difficulty with meeting the assay specifications in the currently official analytical method.
As an interim solution, the Expert Committee proposes to revert the monograph to the previous version that was official prior to December 1, 2022.
It is anticipated that the proposed revision will be published as a Revision Bulletin (RB) on 25 July 2025 pursuant to the Rules and Procedures of the Council of Experts. The RB is anticipated to be official one year from the time of publication. USP allows early adoption of the RB as outlined in the USP General Notices 3.10. Applicability of Standards. Thus, once the RB is published, USP intends to allow users to early adopt the reverted monographs (the version official prior to June 1, 2023). Users who prefer to use the method that became official on June 1, 2023 will be able to continue to do so until the RB becomes official, and afterwards would have the option to justify use of the June 1, 2023 method as an alternative method per General Notices 6.30.
Should you have any questions, please contact Fatkhulla Tadjimukhamedov, Senior Scientist (FKT@usp.org).
This Notice was revised on April 24, 2025 to correct the official date for the currently official monograph.