Hepatitis B Immune Globulin
(hep'' a tye' tis i mune' glob' ue lin).
» 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.
Packaging and storage— Preserve at a temperature between 2 and 8.
Expiration date— Its minimum expiration date is not later than 1 year after the date of manufacture, such date being that of the first valid potency test of the product.
Labeling— Label it to state that it is not for intravenous injection.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Fouad Atouf, Ph.D.
Senior Scientific Liaison
(BIO22010) Monographs - Biologics and Biotechnology 2
USP35–NF30 Page 3408