Diphtheria and Tetanus Toxoids Adsorbed USP (For Pediatric Use),
for intramuscular use, is a sterile
suspension of alum-precipitated
sulfate) toxoid in an isotonic
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.
tetani culture is grown
in a peptone-based medium. Both toxins are detoxified with formaldehyde.
The detoxified materials are then separately purified by serial
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