Tetanus and Diphtheria Toxoids Adsorbed for Adult Use
» Tetanus and Diphtheria Toxoids Adsorbed for Adult Use conforms to the regulations of the FDA concerning biologics (see Biologics 1041). It is a sterile suspension prepared by mixing suitable quantities of adsorbed diphtheria toxoid and adsorbed tetanus toxoid using the same precipitating or adsorbing agent for both toxoids. The antigenicity or potency and the proportions of the toxoids are such as to provide, in each dose prescribed in the labeling, an immunizing dose of Tetanus Toxoid Adsorbed as defined for that product, and one-tenth of the immunizing dose of Diphtheria Toxoid Adsorbed as defined for that product for children, such that in the specific guinea pig antigenicity test it meets the requirement of production of not less than 0.5 unit of diphtheria antitoxin per mL and each immunizing dose has an antigen content of not more than 2 Lf (flocculating units) value as measured with the U.S. Reference Diphtheria Antitoxin for Flocculation Test. Each component meets the other requirements for those products. It contains not more than 0.02 percent of residual free formaldehyde.
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.
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