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<411> Folic Acid Assay and Folic Acid Tablets

Type of Posting: Notice of Intent to Revise
Posting Date: 22–Apr-2022
Targeted Official Date: 01-Nov-2022; Interim Revision Announcement
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 Folic Acid Tablets monograph and general chapter <411> Folic Acid Assay.

USP Folic Acid Related Compound A RS and USP Leucovorin Calcium RS have been identified as being the same chemical. Therefore, the Expert Committee proposes to revise general chapter <411> to replace USP Folic Acid Related Compound A RS with USP Leucovorin Calcium RS in the System suitability solution Procedure 4, and to discontinue the USP Folic Acid Related Compound A RS and to revise the Folic Acid Tablets monograph accordingly.

It is anticipated that the proposed revisions will be published as Interim Revision Announcements in Pharmacopeial Forum 48(3) [May-Jun. 2022] pursuant to the Rules and Procedures. The comment period for this revision ends on July 31, 2022. In the absence of any adverse comments, the proposed IRA will become official on November 1, 2022.

Should you have any questions, please contact Natalia Davydova, Principal Scientist (