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Revision Bulletin

Rocuronium Bromide

Original Posting Date: 27 March 2009; updated 26 February 2010
Revised Revision Bulletin Posting Date 2 September 2009
Official Date: 1 August 2009
Expert Committee: Monograph Development—Psychiatrics and Psychoactives Expert Committee


In accordance with section 9.05(c) of the Rules and Procedures of the 2005–2010 Council of Experts, the Monograph Development—Psychiatrics and Psychoactives Expert Committee (MDPP) has revised the Rocuronium Bromide monograph in order to reflect the approved ANDAs as follows:

  1. Revise the definition to account for the presence of 2–propanol and acetic acid
  2. Revise the current pH range from 8.9–9.5 to 7.0–9.5
  3. Introduce a Limit of acetic acid test with a limit of NMT 5.0%.

The Rocuronium Bromide Revision Bulletin text supersedes the currently official monograph and will be incorporated into USP 33-NF 28 Reissue.

Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301–816–8330 or .

Download the Rocuronium Bromide Monograph  (145KB)