Type of Posting: Revision Bulletin
Posting Date: 26–Jul–2013
Official Date: 01–Aug–2013
Archive Date: 09–Feb–2015
Expert Committee: Monographs—Small Molecules 2
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Hydromorphone Hydrochloride Oral Solution monograph. The purpose of this revision is to widen the pH range from 4.5–6.5 to 3.5–6.5 to accommodate the sponsor’s FDA approved limits. Several minor editorial changes have been made to update the monograph to the current USP style
The Hydromorphone Hydrochloride Oral Solution Revision Bulletin supersedes the currently official monograph and will be incorporated to USP 37–NF 32, First Supplement.
Should you have any questions, please contact Clydewyn Anthony, Ph.D. (301-816-8139 or cma@usp.org).