Type of Posting: Revision Bulletin
Posting Date: 30–May–2014
Targeted Official Date: 01–Jun–2014
Expert Committee: Monographs—Small Molecules 4
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Olanzapine and Fluoxetine Capsules monograph. The purpose for the revision is to increase the limit of total impurities related to olanzapine from NMT 0.8% to NMT 1.5% in the test for Organic Impurities to reflect drug products approved by the FDA.
This Olanzapine and Fluoxetine Capsules Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated into USP 38–NF 33.
Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330, rr@usp.org).