Oxytocin Nasal Solution, chemical structure, molecular formula, Reference Standards

Oxytocin Nasal Solution

»Oxytocin Nasal Solution is a solution of Oxytocin in a suitable diluent.It contains suitable preservatives,and is packaged in a form suitable for nasal administration.Each mLof Oxytocin Nasal Solution possesses an oxytocic activity of not less than 85.0percent and not more than 120.0percent of that stated on the label in USP Oxytocin Units.

Packaging and storage— Preserve in containers suitable for administering the contents by spraying into the nasal cavities with the patient in the upright position,or for instillation in drop form.

Labeling— Label it to indicate that it is for intranasal administration only.Label it to state the origin (animal or synthetic),and the animal source of the product if of animal origin.

USP Reference standards á11ñ— USP Oxytocin RS.USP Vasopressin RS.

pHá791ñ: between 3.7and 4.3.

Vasopressor activity (for product labeled of animal origin)— Proceed as directed in the Assayunder Vasopressin,except to use a Standard solution of USP Vasopressin RScontaining 0.1USP Vasopressin Unit per mLand to use a test solution prepared by diluting a volume of Nasal Solution to a concentration of 10USP Oxytocin Units per mL.The vasopressic activity of the test solution is not more than 0.1USP Oxytocin Unit per mL.

Assay—

Mobile phase A,Mobile phase B,Diluent,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Oxytocin.

Assay preparation— Quantitatively dilute an accurately measured volume of Nasal Solution in Diluentto obtain a solution containing about 10USP Oxytocin Units per mL.

Procedure— Separately inject three equal volumes (about 100µL)of the Assay preparationand the Standard preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the potency,in USP Oxytocin Units per mL,in the portion of Nasal Solution taken by the formula:

C(rU/rS),

in which Cis the concentration,in USP Oxytocin Units per mL,of USP Oxytocin RSin the Standard preparation;and rUand rSare the mean peak responses obtained for oxytocin 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 1455

Phone Number:1-301-816-8385