Ondansetron Orally Disintegrating Tablets

Type of Posting: 
Revision Bulletin
Posting Date: 
24–Nov–2010
Official Date: 
01–Dec–2010
Expert Committee: 
Monographs—Small Molecules 3
Reason for Revision: 
Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Ondansetron Orally Disintegrating Tablets monograph. The purpose for the revision is to accommodate the sponsor’s FDA-approved specifications for Organic impurities as follows:

  • Increase the limit of 2-methylimidazole from NMT 0.15% to NMT 0.2%
  • Increase the limit of any individual unknown impurity from NMT 0.1% to NMT 0.2%

The Ondansetron Orally Disintegrating Tablets Revision Bulletin supersedes the currently official monograph and will be incorporated in the Second Supplement to USP 34–NF 29.

Should you have any questions, please contact Elena Gonikberg, Ph.D. (301-816-8251 or eg@usp.org).