» Oxytocin Injection is a sterile solution of Oxytocin in a suitable diluent. Each mL of Oxytocin Injection possesses an oxytocic activity of not less than 90.0 percent and not more than 110.0 percent of that stated on the label in USP Oxytocin Units.
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass or in suitable plastic containers.
Labeling Label it to indicate its oxytocic activity in USP Oxytocin Units per mL. Label it also to state the animal source if naturally derived, or to state that it is synthetic.
USP Reference standards 11
USP Endotoxin RS
Bacterial endotoxins 85 It contains not more than 35.7 Endotoxin Units per USP Oxytocin Unit.
pH 791: between 3.0 and 5.0.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
Assay Proceed as directed for Oxytocin except to use undiluted Injection as the Assay preparation and to allow not less than 25 minutes between injections. Calculate the potency, in USP Oxytocin Units per mL, by the formula:
C(rU / rS)in which C is the concentration, in USP Oxytocin 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.
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USP35NF30 Page 4193Pharmacopeial Forum: Volume No. 32(6) Page 1750