U.S. PHARMACOPEIA

Search USP29  
Rho (D) Immune Globulin
» Rho (D) Immune Globulin conforms to the regulations of the FDA concerning biologics (see Biologics 1041). 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 10 g and not more than 18 g of protein per 100 mL, not less than 90.0 percent 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 0.3 M glycine as a stabilizing agent and contains a suitable preservative.
Packaging and storage— Preserve at a temperature between 2 and 8.
Expiration date— The expiration date is not later than 6 months from the date of issue from manufacturer's cold storage, or not later than 1 year from the date of manufacture, as indicated on the label.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Tina S. Morris, Ph.D., Senior Scientist
Expert Committee : (BBBBP05) Biologics and Biotechnology - Blood and Blood Products
USP29–NF24 Page 1005
Phone Number : 1-301-816-8397