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 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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Larry N. Callahan, Ph.D.
Senior Scientist
1-301-816-8385
(BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3849
Pharmacopeial Forum: Volume No. 34(4) Page 995
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.