Rho(D)Immune Globulin
»Rho(D)Immune Globulin conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is a sterile,nonpyrogenic solution of globulins derived from human blood plasma containing antibody to the erythrocyte factor Rho(D).It contains not less than 10g and not more than 18g of protein per 100mL,not less than 90.0percent of which is gamma globulin.It has a potency,determined by a suitable method,not less than that of the U.S.Reference Rho(D)Immune Globulin.It contains 0.3Mglycine as a stabilizing agent and contains a suitable preservative.
Packaging and storage— Preserve at a temperature between 2and 8.
Expiration date— The expiration date is not later than 6months from the date of issue from manufacturer's cold storage,or not later than 1year from the date of manufacture,as indicated on the label.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 905
Phone Number:1-301-816-8339