»Hepatitis B Immune Globulin conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).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 Bsurface antigen.It contains not less than 10.0g and not more than 18.0g of protein per 100mL,of which not less than 80percent is monomeric immunoglobulin G,having no ultracentrifugally detectable fragments,nor aggregates having a sedimentation coefficient greater than 12S.It contains 0.3Mglycine as a stabilizing agent,and it contains a suitable preservative.It has a potency per mLnot 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 Bsurface antigen.It has a pHbetween 6.4and 7.2,measured in a solution diluted to contain 1percent of protein with 0.15Msodium chloride.It meets the requirements of the test for heat stability.