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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Tina S. Morris, Ph.D.
Director,Biologics and Biotechnology
(BBVV05) Biologics and Biotechnology - Vaccines and Virology
USP32–NF27 Page 3688
Pharmacopeial Forum: Volume No. 28(4) Page 1194