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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (D's) » Diphtheria and Tetanus Toxoids Adsorbed USP



DESCRIPTION

Diphtheria and Tetanus Toxoids Adsorbed USP (For Pediatric Use), 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.

Corynebacterium diphtheriae culture is grown in a modified Mueller and Miller medium. 1 Clostridium tetani culture is grown in a peptone-based medium. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration. Thimerosal (a mercury derivative) 1:10,000 is added as a preservative.

Each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, and not more than 0.17 mg of aluminum. The residual formaldehyde content, by assay, is less than 0.02%. Both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test.





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