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Revision Bulletin

Fenofibrate Capsules

Posting Date: 29 May 2009; updated 26 February 2010
Official Date: 1 July 2009
Expert Committee: Monograph Development–Gastrointestinal, Renal, and Endocrine


In accordance with the Rules and Procedures of the 2005-2010 Council of Experts, the Monograph Development–Gastrointestinal, Renal, and Endocrine Expert Committee has revised the Fenofibrate Capsules Monograph. Using a flexible monograph approach, the alternative Assay preparation under the Assay and Test solution under the Related compounds are included in the monograph for the Capsules that meet the requirements of the Dissolution Test 2. The Identification test A is deleted, to address comments that the excipient matrix may interfere with the infrared spectrum of the analyte.

The Fenofibrate Capsules Revision Bulletin supersedes the currently official monograph and will be incorporated into the USP 33–NF 28 Reissue.

Should you have any questions, please contact Elena Gonikberg (301–816–8251 or .

Download the Fenofibrate Capsules Monograph  (133KB)