Type of Posting: Revision Bulletin
Posting Date: 27–Jan–2012
Official Date: 01–Feb–2012
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 Amoxicillin and Clavulanate Potassium for Oral Suspension monograph. The purpose of the revision is to revise the specifications for the Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> to reflect the FDA-approved limits:
- The limit of the total aerobic microbial count is raised from 102 cfu/g to 103 cfu/g.
- The limit of the total combined molds and yeasts count is raised from 5 x 101 cfu/g to 102cfu/g.
The Amoxicillin and Clavulanate Potassium for Oral Suspension Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 35–NF 30.
Should you have any questions, please contact Ahalya Wise, M.S. (301-816-8161 or aww@usp.org).