» Hepatitis B Immune Globulin conforms to the regulations of the FDA concerning biologics (see Biologics 1041). It is a sterile, nonpyrogenic solution free from turbidity, consisting of globulins derived from the blood plasma of human donors who have high titers of antibodies against hepatitis B surface antigen. It contains not less than 10.0 g and not more than 18.0 g of protein per 100 mL, of which not less than 80 percent is monomeric immunoglobulin G, having no ultracentrifugally detectable fragments, nor aggregates having a sedimentation coefficient greater than 12S. It contains 0.3 M glycine as a stabilizing agent, and it contains a suitable preservative. It has a potency per mL not less than that of the U. S. Reference Hepatitis B Immune Globulin tested by an approved radioimmunoassay for the detection and measurement of antibody to hepatitis B surface antigen. It has a pH between 6.4 and 7.2, measured in a solution diluted to contain 1 percent of protein with 0.15 M sodium chloride. It meets the requirements of the test for heat stability.