Revision Bulletin

Midazolam

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 monograph in USP 32–NF 27 Second Supplement and will be incorporated into USP 33–NF 28 First Supplement.

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

Download the Midazolam Revision Bulletin  (116KB)