Vasopressin Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
» 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.
1 Packaging and storage-
Preserve in single-dose or multiple-dose containers, preferably of Type I glass. Do not freeze.
2 Labeling-
Label it to indicate its origin (animal or synthetic). Label it also to state the potency in USP Vasopressin Units per mL..
3 USP REFERENCE STANDARDS (11)-
USP Vasogressin RS
BACTERIAL ENDOTOXINS TEST (85) -It contains not more than 17.0 Endotoxin Units per USP Vasopressin Unit.
pH (791): between 2.5 and 4.5.
PARTICULATE MATTER IN INJECTIONS (788), -It meets the requirements under small-volume injections.
Other requirements-It meets the requirements under Injections and Implanted Drug Products (1).
4 Assay-
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 glacialacetic acid, add 5.0 g of alcohol, 1.1 g of sodium acetate, and 1000mL of water, and mix.
Standard preparation-Dissolve the entire contents of a vial ofUSP Vasopressin RS in a known volume of Diluent. [NOTE-The solution may be diluted as necessary to a workingconcentration 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)
S 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. [NOTE-The runtime should be long enough to allow for the elution of the chlorobutanol peak (approximately 60 minutes).]
