Type of Posting: Revision Bulletin
Posting Date: 29–Jun–2012
Official Date: 01–Jul–2012
Archive Date: 09–Feb–2015
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 monograph for Olanzapine Tablets. The purpose for the revision is to:
- Widen the limit of olanzapine related compound B under Organic impurities from NMT 0.20% to NMT 0.50%, to be consistent with FDA approved specifications. The limit of total impurities remains unchanged.
- Add a clarification to the preparation of the Sample solution in the Assay.
- Add a note under Assay and Organic Impurities that a few drops of acetonitrile may be added to the Standard and Sample solutions prior to final dilution, to reduce foaming.
The Olanzapine Tablets Revision Bulletin supersedes the currently official Olanzapine Tablets monograph. The Revision Bulletin will be incorporated in USP 36–NF 31.
Should you have any questions, please contact Hari Ramanathan, M.S. (301-816-8313 or hr@usp.org).