Tetanus Immune Globulin
(tet' a nus i mune' glob' ue lin).
» 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.
Packaging and storage— Preserve at a temperature between 2 and 8.
Expiration date— The expiration date for Tetanus Immune Globulin containing a 10% excess of potency is not later than 3 years after date of issue from manufacturer's cold storage (5, 1 year).
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 Anita Y. Szajek, Ph.D.
Principal Scientific Liaison
(BIO22010) Monographs - Biologics and Biotechnology 2
USP35–NF30 Page 4803