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Varicella-Zoster Immune Globulin
»Varicella-Zoster Immune Globulin conforms to the regulations of the FDA concerning biologics (see Biologics 1041). It is a sterile 15 percent to 18 percent solution of pH 7.0 containing the globulin fraction of human plasma consisting of not less than 99 percent of immunoglobulin G with traces of immunoglobulin A and immunoglobulin M, in 0.3 M glycine as a stabilizer and 1:10,000 thimerosal as a preservative. It is derived from adult human plasma selected for high titers of varicella-zoster antibodies. Each unit of blood or plasma has been found nonreactive for hepatitis B surface antigen by a suitable method. The proteins of the plasma pools are fractionated by the cold ethanol precipitation method. The content of specific antibody is not less than 125 units, deliverable from a vial containing not more than 2.5 mL solution. The unit is defined as equivalent to 0.01 mL of a Varicella-Zoster Immune Globulin lot found effective in clinical trials and used as a reference for potency determinations, based on a fluorescent-antibody membrane antigen (FAMA) method for antibody titration.
Packaging and storage— Preserve at a temperature between 2 and 8.
Expiration date— The expiration date is not later than 2 years after date of issue from manufacturer's cold storage.
Labeling— Label it to state that it is to be administered by intramuscular injection, in the recommended dose based on body weight.
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 2242
Phone Number : 1-301-816-8397