Type of Posting: Revision Bulletin
Posting Date: 31–May–2012
Official Date: 01–Jun–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. The purpose for the revision is to add a new impurity, chloromethyl olanzapinium chloride, with an acceptance criterion of NMT 0.15% to the Organic impurities procedure. The limit of total impurities remains unchanged.
The Olanzapine Revision Bulletin supersedes the currently official Olanzapine 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).