Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass.Store at controlled room temperature.

Labeling— Label it to indicate the approximate neutralization capacity in USP Heparin Units.

USP Reference standards á11ñ— USP Endotoxin RS.USP Heparin Sodium RS.

Identification— It responds to the tests for Sulfate á191ñ.

Bacterial endotoxins á85ñ— It contains not more than 7.0USP Endotoxin Units per mg of protamine sulfate.

Other requirements— It meets the requirements under Injections á1ñ.

Assay— Using as the Assay preparationa solution prepared by diluting with Water for Injection an accurately measured volume of Injection to give an estimated final concentration of protamine sulfate of 1mg per mL,proceed as directed in the Assayunder Protamine Sulfate.The potency,in mg of protamine sulfate in each mLof the Injection,is given by the formula: in which vand Vare the volumes,in mL,respectively,of the Heparin preparationand of the Injection present in the last tube prior to the first one in which the clotting time is not less than 2seconds longer than that in the control tube.

Expert Committee:(BBP)Blood and Blood Products

USP28–NF23Page 1668

Phone Number:1-301-816-8339