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Vasopressin

Type of Posting: Revision Bulletin

Posting Date: 30–Jun–2011

Official Date: 01–Jul–2011

Expert Committee: Monographs—Biologics and Biotechnology 1

Reason for Revision: Compliance

In accordance with section 7.05 (c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the Monographs—Biologics and Biotechnology 1 Expert Committee has revised the Vasopressin monograph based on comments received. The purpose of the revision is to:

  • Widen the assay acceptance criteria that are currently set at “not less than 95.0 percent and not more than 102.0 percent" vasopressin. The assay acceptance criteria will be revised to “not less than 95.0 percent and not more than 105.0 percent" vasopressin. This revision is based on batch data that USP received from vasopressin API manufacturers. The assay result calculation will also be revised to the following: Calculate the percent of vasopressin content on the anhydrous and acetic acid-free basis by the following formula: ru/rs x Cs/Cu x100.

This Vasopressin Revision Bulletin supersedes the currently official USP vasopressin monograph. The Revision Bulletin will be incorporated in USP 35–NF 30.

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