Type of Posting: Revision Bulletin
Posting Date: 22–Mar–2013
Official Date: 01–Apr–2013
Archive Date: 09–Feb–2015
Expert Committee: Monographs—Small Molecules 1
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 1 Expert Committee has revised the Tobramycin Inhalation Solution monograph. The purpose of the revision is to revise the following limits to accommodate a new product recently approved by the FDA:
- The absorbance is revised from NMT 0.24 to NMT 0.30.
- The pH range is revised from 5.5–6.5 to 4.5–6.5.
- The osmolality range is revised from 135–200 to 135–285.
The Tobramycin Inhalation Solution Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in USP 37–NF 32.
Should you have any questions, please contact Ahalya Wise (301-816-8161 or aww@usp.org).