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 / V
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.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 3435
Pharmacopeial Forum: Volume No. 29(4) Page 1065
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