Diphtheria and Tetanus Toxoids Adsorbed
»Diphtheria and Tetanus Toxoids Adsorbed conforms to the regulations of the FDA concerning biologics (see Biologics 1041). It is a sterile suspension prepared by mixing suitable quantities of plain or adsorbed diphtheria toxoid and plain or adsorbed tetanus toxoid, and an aluminum adsorbing agent if plain toxoids are used. The antigenicity or potency and the proportions of the toxoids are such as to provide an immunizing dose of each toxoid in the total dosage prescribed in the labeling, and each component meets the 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 2179