Tetanus Toxoid Adsorbed USP, for intramuscular use, is a sterile suspension of alum-precipitated (aluminum potassium sulfate) toxoid in an isotonic sodium chloride solution containing sodium phosphate buffer to control pH. The vaccine, after shaking, is a turbid liquid, whitish-gray in color.

Clostridium tetani culture is grown in a peptone-based medium and detoxified with formaldehyde. The detoxified material is then purified by serial ammonium sulfate fractionation, followed by sterile filtration, and the toxoid is adsorbed to aluminum potassium sulfate (alum). The adsorbed toxoid is diluted with physiological saline solution (0.85%) and thimerosal (a mercury derivative) is added to a final concentration of 1:10,000.

Each 0.5 mL dose is formulated to contain 5 Lf (flocculation units) of tetanus toxoid and not more than 0.25 mg of aluminum. The residual formaldehyde content, by assay, is less than 0.02%. The tetanus toxoid induces at least 2 units of antitoxin per mL in the guinea pig potency test.

Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.