Tetanus antitoxin is a liquid preparation containing antitoxic globulin. It is obtained by purification following pepsin digestion from the plasma of horses that have been immunized with tetanus toxoid. It is used for the prevention and treatment of tetanus infection cause by clotridium tetani.The potency of tetanus antitoxin shall be not less than 2000IU/ml in antitoxin for prophylaxis use, and the specific activity shall be not less than 45000IU/g of protein for prophylactic use. The potency of tetanus antitoxin shall be not less than 3000IU/ml for therapeutic use, not less than 55000IU/g of protein for therapeutic use (General Principles 3508). The filling quantity in each container shall be not less than the stated value.
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