» Tetanus Immune Globulin conforms to the regulations of the FDA concerning biologics (see Biologics 1041). It is a sterile, nonpyrogenic solution of globulins derived from the blood plasma of adult human donors who have been immunized with tetanus toxoid. It has a potency of not less than 50 antitoxin units per mL based on the U.S. Standard Tetanus Antitoxin and the U.S. Control Tetanus Test Toxin, tested in guinea pigs. It contains not less than 10 g and not more than 18 g of protein per 100 mL, of which not less than 90 percent is gamma globulin. It contains 0.3 M glycine as a stabilizing agent, and it contains a suitable preservative.