Protamine Sulfate Injection
» Protamine Sulfate Injection is a sterile, isotonic solution of Protamine Sulfate. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of protamine sulfate.
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.
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.
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:
v / Vin 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.
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USP32NF27 Page 3435Pharmacopeial Forum: Volume No. 29(4) Page 1065