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.
Topic/Question Contact Expert Committee
Monograph Anita Y. Szajek, Ph.D.
Senior Scientist
(BBBBP05) Biologics and Biotechnology - Blood and Blood Products
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3435
Pharmacopeial Forum: Volume No. 29(4) Page 1065