Midazolam

Type of Posting: 
Revision Bulletin
Posting Date: 
30–Oct–2009; updated 26–Feb–2010
Official Date: 
01–Dec–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 msw@usp.org).