Type of Posting: Revision Bulletin
Posting Date: 26–Feb–2010
Official Date: 01–Apr–2010
Expert Committee: Monograph Development—Antibiotics
In accordance with the Rules and Procedures of the 2005–2010 Council of Experts, the Monograph Development—Antibiotics Expert Committee has revised the Azithromycin Tablets Monograph. The purpose for the revision is to accommodate the sponsor’s FDA-approved acceptance criteria for degradation products in the test for Organic Impurities.
The Azithromycin Tablets Revision Bulletin supersedes the currently official monograph and will be incorporated into the Second Supplement to the USP 33–NF 28 Reissue.
Should you have any questions, please contact Ahalya Wise (301-816-8161 or aww@usp.org).