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

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

USP Reference standards 11— USP Endotoxin RS. USP Heparin Sodium RS.

Identification— It responds to the tests for Sulfate 191.

Bacterial endotoxins 85— It contains not more than 7.0 USP Endotoxin Units per mg of protamine sulfate.

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements under Injections 1.

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

Expert Committee : (BBBBP05) Biologics and Biotechnology - Blood and Blood Products

USP29–NF24 Page 1853

Phone Number : 1-301-816-8385