U.S. PHARMACOPEIA

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Schick Test Control
» Schick Test Control conforms to the regulations of the FDA concerning biologics (see Biologics 1041). It is Diphtheria Toxin for Schick Test that has been inactivated by heat for use as control for the Schick Test. It meets the requirements of the specific guinea pig test for detoxification by injection of not less than 2.0 mL into each of at least four guinea pigs. The animals are observed daily for 30 days and during this period show no evidence of diphtheria toxin poisoning (extensive necrosis, paralysis, or specific lethality).
Packaging and storage— Preserve at a temperature between 2 and 8.
Expiration date— The expiration date is not later than 1 year after date of issue from manufacturer's cold storage (5, 1 year).
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Tina S. Morris, Ph.D., Senior Scientist
Expert Committee : (BBVV05) Biologics and Biotechnology - Vaccines and Virology
USP29–NF24 Page 1949
Phone Number : 1-301-816-8397