Tetanus Toxoid Adsorbed
»Tetanus Toxoid Adsorbed conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).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 2and 8.
Expiration date— The expiration date is not later than 2years after date of issue from manufacturer's cold storage (5,1year).
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 0.85mg per single injection,determined by analysis,or not more than 1.14mg calculated on the basis of the amount of aluminum compound added.
Auxiliary Information— Staff Liaison:Tina S.Morris,Ph.D.,Senior Scientist
Expert Committee:(VVI)Vaccines,Virology,and Immunology
USP28–NF23Page 1879
Phone Number:1-301-816-8397
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