Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass. Store between 2 and 8.

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. USP Oxytocin 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.

Residual solvents 467: meets the requirements.

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: 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.

Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides

USP29–NF24 Page 1623

Phone Number : 1-301-816-8385