Type of Posting: Revision Bulletin
Posting Date: 31–Jan–2014
Official Date: 01–Feb–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 Fluconazole for Oral Suspension monograph. The purpose for the revision is to include Dissolution Test 2 and widen the impurity limits, based on the specifications approved by FDA. In addition, minor editorial changes have been made for consistency.
The Fluconazole for Oral Suspension Revision Bulletin supersedes the currently official Fluconazole for Oral Suspension monograph. The Revision Bulletin will be incorporated in to USP 37–NF 32 S2.
Should you have any questions, please contact Shankari Shivaprasad, Ph.D. (301-230-7426, sns@usp.org).