Type of Posting: Revision Bulletin
Posting Date: 26–Sep–2014
Official Date: 01–Oct–2014
Expert Committee: Monographs—Small Molecules 1
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 1 Expert Committee has revised the Ciprofloxacin Extended-Release Tablets monograph. The purpose for the revision is to include Dissolution Test 3, based on the specifications approved by FDA.
In addition, the calculation sections throughout the monograph are revised to update the definition for Mr2 from “molecular weight of ciprofloxacin hydrochloride” to “molecular weight of anhydrous ciprofloxacin hydrochloride”, for clarity and to be consistent across the family of ciprofloxacin monographs.
The Ciprofloxacin Extended-Release Tablets Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated into First Supplement to USP 38–NF 33.
Should you have any questions, please contact Shankari Shivaprasad, Ph.D. (301-230-7426, sns@usp.org).