U.S. PHARMACOPEIA

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Tetanus Toxoid
» Tetanus Toxoid conforms to the regulations of the FDA concerning biologics (see Biologics 1041). It is a sterile solution of the formaldehyde-treated products of growth of the tetanus bacillus (Clostridium tetani). It meets the requirements of the specific guinea pig potency test of antitoxin production based on the U.S. Standard Tetanus Antitoxin and the U.S. Control Tetanus Test Toxin. It meets the requirements of the specific guinea pig detoxification test. It contains not more than 0.02 percent of residual free formaldehyde. It contains a preservative other than a phenoloid compound.
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 (5, 1 year).
Labeling— Label it to state that it is not to be frozen.
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 2090
Pharmacopeial Forum : Volume No. 28(4) Page 1194
Phone Number : 1-301-816-8397