Type of Posting: Revision Bulletin
Posting Date: 22–Nov–2013
Official Date: 01–Dec–2013
Archive Date: 09–Feb–2015
Expert Committee: Monographs—Small Molecules 2
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Fenofibrate Tablets monograph. The purpose of the revision is to widen the acceptance criteria listed in Table 1 under Organic Impurities section as follows:
- Fenofibrate related compound B: from NMT 0.2% to 0.50%.
- Total impurities: from NMT 0.3% to NMT 1.0%
The Fenofibrate Tablets Revision Bulletin supersedes the currently official monograph. This Revision Bulletin will be incorporated in Second Supplement to USP 37–NF 32.
Should you have any questions, please contact Sujatha Ramakrishna Ph.D., MBA (301-816-8349 or sxr@usp.org).