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 mL of Oxytocin Nasal Solution possesses an oxytocic activity of not less than 85.0 percent and not more than 120.0 percent 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.
pH 791: between 3.7 and 4.3.
Vasopressor activity (for product labeled of animal origin) Proceed as directed in the Assay under Vasopressin, except to use a Standard solution of USP Vasopressin RS containing 0.1 USP Vasopressin Unit per mL and to use a test solution prepared by diluting a volume of Nasal Solution to a concentration of 10 USP Oxytocin Units per mL. The vasopressic activity of the test solution is not more than 0.1 USP Oxytocin Unit per mL.
Mobile phase A, Mobile phase B, Diluent, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Oxytocin.
Assay preparation Quantitatively dilute an accurately measured volume of Nasal Solution in Diluent to obtain a solution containing about 10 USP Oxytocin Units per mL.
Procedure Separately inject three equal volumes (about 100 µL) of the Assay preparation and the Standard preparation into 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 C is the concentration, in USP Oxytocin Units per mL, of USP Oxytocin RS in the Standard preparation; and rU and rS are the mean peak responses obtained for oxytocin from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 3186