Revision Bulletin

Midazolam Injection

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 Injection monograph based on data provided by an FDA-approved sponsor as follows:

1. Revised the pH range from "between 2.5 and 3.5" to "between 2.5 and 3.7"
2. Revised the acceptance criteria for Content of benzyl alcohol from "between 90% and 110% of the labeled amount is found" to "the content of benzyl alcohol meets the requirements for Added Substances under Injections <1>".

This Midazolam Injection 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 Injection Revision Bulletin  (122KB)