»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.
USP Reference standards 11
USP Endotoxin RS
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.
Other requirements It meets the requirements under Injections 1.
Mobile phase, System suitability solution, Chromatographic system, and Procedure Proceed as directed in the Assay under Vasopressin.
Diluent Dissolve 5.0 g of chlorobutanol in 5.0 mL of glacial acetic acid, add 5.0 g of alcohol, 1.1 g of sodium acetate, and 1000 mL of water, and mix.
Standard preparation Dissolve the entire contents of a vial of USP Vasopressin RS in a known volume of Diluent. [noteThe solution may be diluted as necessary to a working concentration range for the Assay. ]
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.
Procedure 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. [noteThe runtime should be long enough to allow for the elution of the chlorobutanol peak (approximately 60 minutes). ]
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USP35NF30 Page 5006Pharmacopeial Forum: Volume No. 34(4) Page 995