U.S. PHARMACOPEIA

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Vasopressin Injection
»Vasopressin Injection is a sterile solution of Vasopressin in a suitable diluent. Each mL of Vasopressin Injection possesses an activity of not less than 90.0 percent and not more than 110.0 percent of that stated on the label in USP Vasopressin Units. It may contain a suitable preservative.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass. Do not freeze.
Labeling— Label it to indicate its origin (animal or synthetic). Label it also to state the potency in USP Vasopressin Units per mL.
Bacterial endotoxins 85— It contains not more than 17.0 Endotoxin Units per USP Vasopressin Unit.
pH 791: between 2.5 and 4.5.
Particulate matter 788— It meets the requirements under small-volume injections.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay—
Mobile phase , Standard preparation, Chromatographic system, and Procedure—Proceed as directed in the Assay under Vasopressin.
Assay preparation— Pipet 2.0 mL of Injection into a 25-mL volumetric flask, dilute with 0.25% glacial acetic acid to volume, and mix. Calculate the potency, in USP Vasopressin Units per mL, by the formula:
C(rU / rS),
in which C is the concentration, in USP Vasopressin Units per mL, of the Standard preparation; and rU and rS are the mean values of the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Larry N. Callahan, Ph.D., Scientist
Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
USP29–NF24 Page 2243
Phone Number : 1-301-816-8385