Oxytocin Injection
»Oxytocin Injection is a sterile solution of Oxytocin in a suitable diluent.Each mLof Oxytocin Injection possesses an oxytocic activity of not less than 90.0percent and not more than 110.0percent of that stated on the label in USP Oxytocin Units.
Change to read:
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass.Store between 2and 8.USP28
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.
Bacterial endotoxins á85ñ— It contains not more than 35.7Endotoxin Units per USP Oxytocin Unit.
pHá791ñ: between 3.0and 5.0.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Proceed as directed for Oxytocinexcept to use undiluted Injection as the Assay preparationand to allow not less than 25minutes between injections.Calculate the potency,in USP Oxytocin Units per mL,by the formula:
C(rU/rS),
in which Cis the concentration,in USP Oxytocin Units per mL,of the Standard preparation;and rUand rSare the mean values of the peak responses obtained 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
Pharmacopeial Forum:Volume No.30(1)Page 153
Phone Number:1-301-816-8385