Tetanus Toxoid Adsorbed
» Tetanus Toxoid Adsorbed conforms to the regulations of the FDA concerning biologics (see Biologics 1041). It is a sterile preparation of plain tetanus toxoid that meets all of the requirements for that product with the exception of those for potency, and that has been precipitated or adsorbed by alum, aluminum hydroxide, or aluminum phosphate adjuvants. It meets the requirements of the specific mouse or guinea pig potency test of antitoxin production based on the U.S. Standard Tetanus Antitoxin and the U.S. Control Test Tetanus Toxin. It meets the requirements of the specific guinea pig detoxification test.
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 to be well-shaken before use and that it is not to be frozen.
Aluminum content— It contains not more than 0.85 mg per single injection, determined by analysis, or not more than 1.14 mg calculated on the basis of the amount of aluminum compound added.
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