Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.Preserve the accompanying solvent in single-dose or in multiple-dose containers,preferably of Type Iglass.

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

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

Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.

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

pHand clarity of solution— Dissolve it in the solvent recommended in the labeling:the pHof the solution is between 6.5and 7.5,and the solution is clear.

Other requirements— Both it and the accompanying solvent meet the requirements for Sterility Tests á71ñand Labelingunder Injections á1ñ.It meets also the requirements for Uniformity of Dosage Units á905ñ.

Assay— Using as the Assay preparationa solution prepared by dissolving the contents of 1container of Protamine Sulfate for Injection in Water for Injection to give a final concentration of about 1mg of protamine sulfate per mL,proceed as directed in the Assayunder Protamine Sulfate.Calculate the potency,in mg,of protamine sulfate in each mLof the Assay preparationtaken by the formula: in which vand Vare the volumes,in mL,respectively,of the Heparin preparationand the Assay preparationpresent in the last tube prior to the first one in which the clotting time is not less than 2seconds longer than in the control tube.

Expert Committee:(BBP)Blood and Blood Products

USP28–NF23Page 1668

Phone Number:1-301-816-8339