Calcitonin Salmon Injection

Type of Posting: 
Revision Bulletin
Posting Date: 
29–Oct–2010
Official Date: 
01–Nov–2010
Expert Committee: 
Biologics & Biotechnology, Monographs 1
Reason for Revision: 
Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Biologics and Biotechnology—Monographs 1 Expert Committee has revised the Calcitonin Salmon Injection monograph based on data provided by an FDA-approved sponsor as follows:

  1. Revised the upper limit of the Assay acceptance criteria from NMT 110 percent to NMT 120 percent
  2. Revised the Definition to be consistent with the Assay acceptance criteria

The Calcitonin Salmon Injection Revision Bulletin supersedes the monograph in USP 32–NF 27 Second Supplement. The Revision Bulletin will be incorporated into First Supplement to USP 34–NF 29.

Should you have any questions, please contact Tom A. Sigambris (301-998-6789 or tzs@usp.org).