Protamine Sulfate for Injection
» Protamine Sulfate for Injection is a sterile mixture of Protamine Sulfate with one or more suitable, dry diluents. 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 Containers for Sterile Solids as described under Injections 1. Preserve the accompanying solvent in single-dose or in multiple-dose containers, preferably of Type I glass.
Labeling Label it to indicate the approximate neutralization capacity in USP Heparin Units.
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85 It contains not more than 7.0 USP Endotoxin Units per mg of protamine sulfate.
pH and clarity of solution Dissolve it in the solvent recommended in the labeling: the pH of the solution is between 6.5 and 7.5, and the solution is clear.
Other requirements Both it and the accompanying solvent meet the requirements for Sterility Tests 71 and Labeling under Injections 1. It meets also the requirements for Uniformity of Dosage Units 905.
Assay Using as the Assay preparation a solution prepared by dissolving the contents of 1 container of Protamine Sulfate for Injection in Water for Injection to give a final concentration of about 1 mg of protamine sulfate per mL, proceed as directed in the Assay under Protamine Sulfate. Calculate the potency, in mg, of protamine sulfate in each mL of the Assay preparation taken by the formula:
v / Vin which v and V are the volumes, in mL, respectively, of the Heparin preparation and the Assay preparation present in the last tube prior to the first one in which the clotting time is not less than 2 seconds longer than in the control tube.
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USP32NF27 Page 3435