Vasopressin Injection
»Vasopressin Injection is a sterile solution of Vasopressin in a suitable diluent.Each mLof Vasopressin Injection possesses an activity of not less than 90.0percent and not more than 110.0percent 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 Iglass.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 á85ñ— It contains not more than 17.0Endotoxin Units per USP Vasopressin Unit.
pHá791ñ: between 2.5and 4.5.
Particulate matter á788ñ— It meets the requirements under small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase ,Standard preparation,Chromatographic system,and Procedure—Proceed as directed in the Assayunder Vasopressin.
Assay preparation— Pipet 2.0mLof Injection into a 25-mLvolumetric 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 Cis the concentration,in USP Vasopressin Units per mL,of the Standard preparation;and rUand rSare the mean values of the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Larry N.Callahan,Ph.D.,Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 2017
Phone Number:1-301-816-8385