A-Z Index
Image Cart
              

 Information For:

Manufacturers

Regulator

Healthcare

Consumers

Members

Revision Bulletin

Midazolam

Posting Date: 30 October 2009; updated 26 February 2010
Official Date: 1 December 2009
Expert Committee: Monograph Development—Pulmonary and Steroids


In accordance with the Rules and Procedures of the 2005-2010 Council of Experts, the Monograph Development-Pulmonary and Steroids Expert Committee has revised the Midazolam monograph by increasing the limit for the desfluoromidazolam impurity in the Chromatographic purity procedure from NMT 0.1% to NMT 0.2%, based on data provided by an FDA-approved sponsor.

This Midazolam Revision Bulletin supersedes the currently official monograph and will be incorporated into the First Supplement to the USP 33–NF 28 Reissue.

Should you have any questions, please contact Mary Waddell (301-816-8124 or ).

Download the Midazolam Revision Bulletin  (116KB)