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Potassium Citrate Extended-Release Tablets

Type of Posting: Revision Bulletin

Posting Date: 30–Jan–2015

Official Date: 01–Feb–2015

Expert Committee: Monographs—Dietary Supplements and Herbal Medicines

Reason for Revision: Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Dietary Supplements and Herbal Medicines Expert Committee has revised the Potassium Citrate Extended-Release Tablets monograph. The purpose for the revision is to revise the Definition section to be consistent with the labeling information for Potassium Citrate Extended-Release Tablets approved by FDA and to add Dissolution Test 2 for drug product approved by the FDA. Equations for calculation of the amount of potassium citrate dissolved using Dissolution Test 1 were also added.

Additionally, minor editorial changes have been made to update the monograph to current USP style.

The Potassium Citrate Extended-Release Tablets Revision Bulletin supersedes the currently official Potassium Citrate Extended-Release Tablets monograph. The Revision Bulletin will be incorporated in Second Supplement to the USP 38–NF 33.

Should you have any questions, please contact Natalia Davydova, Scientific Liaison (301-816-8328 or nd@usp.org).