Diphtheria and Tetanus Toxoids Adsorbed USP (For Pediatric Use) (DT), for intramuscular use, is a sterile suspension of alum-precipitated (aluminum potassium sulfate) toxoid in an isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish-gray in color.

Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium.¹ Clostridium tetani cultures are grown in a peptone-based medium containing bovine extract. The meat used in this medium is US sourced. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration. The 1 dose vial of vaccine is formulated without preservatives but contains a trace amount of thimerosal (a mercury [Hg] containing compound) from the manufacturing process (≤0.3 mg Hg/0.5 mL dose).The multidose (5 mL) vial of vaccine contains the preservative thimerosal (25 mg Hg/0.5 mL dose).

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.

REFERENCES

1. Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 40:21-32,1941

Last reviewed on RxList: 6/8/2006
This monograph has been modified to include the generic and brand name in many instances.