Tetanus Immune Globulin
»Tetanus Immune Globulin conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).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 50antitoxin units per mLbased on the U.S.Standard Tetanus Antitoxin and the U.S.Control Tetanus Test Toxin,tested in guinea pigs.It contains not less than 10g and not more than 18g of protein per 100mL,of which not less than 90percent is gamma globulin.It contains 0.3Mglycine as a stabilizing agent,and it contains a suitable preservative.
Packaging and storage— Preserve at a temperature between 2and 8.
Expiration date— The expiration date for Tetanus Immune Globulin containing a 10%excess of potency is not later than 3years after date of issue from manufacturer's cold storage (5,1year).
Labeling— Label it to state that it is not for intravenous injection.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 1878
Phone Number:1-301-816-8339