Tetanus Toxoid
»Tetanus Toxoid conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).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 0.02percent of residual free formaldehyde.It contains a preservative other than a phenoloid compound.
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 not to be frozen.
Auxiliary Information— Staff Liaison:Tina S.Morris,Ph.D.,Senior Scientist
Expert Committee:(VVI)Vaccines,Virology,and Immunology
USP28–NF23Page 1879
Pharmacopeial Forum:Volume No.28(4)Page 1194
Phone Number:1-301-816-8397
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