Immune Globulin
» Immune Globulin conforms to the regulations of the FDA concerning biologics (640.100 to 640.104) (see Biologics 1041). It is a sterile, nonpyrogenic solution of globulins that contains many antibodies normally present in adult human blood, prepared by pooling approximately equal amounts of material (source blood, plasma, serum, or placentas) from not less than 1000 donors. It contains not less than 15 g and not more than 18 g of protein per 100 mL, not less than 90.0 percent of which is gamma globulin. It contains 0.3 M glycine as a stabilizing agent and contains a suitable preservative. It has a potency of component antibodies of diphtheria antitoxin based on the U.S. Standard Diphtheria Antitoxin and a diphtheria test toxin, tested in guinea pigs (not less than 2 antitoxin units per mL), and antibodies for measles and poliovirus. It meets the requirements of the tests for heat stability in absence of gelation on heating, and for pH.
Packaging and storage— Preserve at a temperature between 2 and 8.
Expiration date— The expiration date is not later than 3 years after date of issue from manufacturer's cold storage (5, 3 years).
Labeling— Label it to state that passive immunization with Immune Globulin modifies hepatitis A, prevents or modifies measles, and provides replacement therapy in persons having hypo- or agammaglobulinemia, that it is not standardized with respect to antibody titers against hepatitis B surface antigen and that it should be used for prophylaxis of viral hepatitis type B only when the specific Immune Globulin is not available, that it may be of benefit in women who have been exposed to rubella in the first trimester of pregnancy but who would not consider a therapeutic abortion, and that it may be used in immunosuppressed patients for passive immunization against varicella if the specific Immune Globulin is not available. Label it also to state that it is not indicated for routine prophylaxis or treatment of rubella, poliomyelitis, or mumps, or for allergy or asthma in patients who have normal levels of immunoglobulin, that the plasma units from which it has been derived have been tested and found non-reactive for hepatitis B surface antigen, and that it should not be administered intravenously but be given intramuscularly, preferably in the gluteal region.
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
1-301-816-8365
(BIO22010) Monographs - Biologics and Biotechnology 2
USP35–NF30 Page 3342