Type of Posting: Revision Bulletin
Posting Date: 31–Jan–2014
Official Date: 01–Feb–2014
Expert Committee: Monographs—Small Molecules 4
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Theophylline Oral Solution Monograph. The purpose for the revision is to widen the pH specification from “4.3 to 4.7” to “3.0 to 4.7” to be consistent with the sponsor’s FDA-approved specifications.
The Theophylline Oral Solution Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 37–NF 32.
Should you have any questions, please contact Mary P. Koleck, Ph.D. (301-230-7420 or mpk@usp.org).