DEFINITION

Protamine Sulfate Injection is a sterile, isotonic solution of Protamine Sulfate. Protamine Sulfate used in the manufacture of Protamine Sulfate Injection complies with the compendial requirements stated in the Protamine Sulfate monograph. Each mg of Protamine Sulfate, used in the manufacture of the Injection, neutralizes NLT 100 USP Heparin Units, calculated on the dried basis. It contains NLT 90.0% and NMT 120.0% of the labeled amount of protamine sulfate.