Type of Posting: Revision Bulletin
Posting Date: 30–Dec–2010
Official Date: 01–Jan–2011
Expert Committee: Monographs—Biologics and Biotechnology 1
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Biologics and Biotechnology 1 Expert Committee has revised the Vasopressin monograph based on data provided by an FDA-approved sponsor as follows:
- Removed the Note from the Definition section in the monograph that states: "One mg of anhydrous Vasopressin is equivalent to 410 USP Vasopressin Units"
The purpose for this revision is to remove the potency unit assignment from the monograph. The potency unit assignment is based on the label claim of the Reference Standard and varies from lot-to-lot. The current lot is 530 USP Vasopressin Units per mg and not 410 Units. Since this unit assignment is addressed by the reference standard label, it is not needed in the monograph, The definition states that the acceptance criteria to be: NLT 95.0% and NMT 102.0% of the label claim, this is sufficient information for the user of the reference standard.
This Vasopressin Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 34–NF 29.
Should you have any questions, please contact Tom A. Sigambris (301-998-6789 or tzs@usp.org).