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.
Other requirements
It meets the requirements under Injections 1.
Assay
Mobile phase
, Standard preparation, Chromatographic system, and ProcedureProceed 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
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 3849
Pharmacopeial Forum: Volume No. 34(4) Page 995
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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