Type of Posting: Revision Bulletin
Posting Date: 29–Jan–2010; updated 18–Mar–2010
Official Date: 01–Mar–2010
Expert Committee: Biologics & Biotechnology, Proteins & Polysaccharides
In accordance with the Rules and Procedures of the 2005–2010 Council of Experts, the Biologics & Biotechnology, Proteins & Polysaccharides Expert Committee has revised the Calcitonin Salmon Nasal Solution monograph based on data provided by an FDA–approved sponsor as follows:
- Revised the upper limit of the Assay acceptance criteria from NMT 110 percent to NMT 115 percent.
- Revised the Definition to be consistent with the Assay acceptance criteria.
This Calcitonin Salmon Nasal Solution Revision Bulletin supersedes the currently official monograph and will be incorporated in the Second Supplement to the USP 33–NF 28 Reissue.
Should you have any questions, please contact Tom A. Sigambris (301-998-6789 or tzs@usp.org).