Tuberculin PPD 1 (Mantoux) Tubersol
® for intracutaneous
(Mantoux) tuberculin testing is available in stabilized solutions
bio-equivalent to 5 U. S. units (TU) PPD-S per
(0.1 ml) and stabilized solutions diluted to a calculated bio-equivalence
of 1 TU and 250 TU strengths per
test dose (0.1 ml).
Tubersol ® is prepared by the
Connaught Laboratories Limited from a large Master Batch, Connaught
Tuberculin (CT68), which has been obtained from a human
strain of Mycobacterium
tuberculosis grown on a protein-free synthetic
medium. The use of a standard
preparation derived from a single batch (CT68) has been recommended
2 in order to eliminate
batch to batch variation
by the same manufacturer.
Tubersol ® is a sterile
isotonic solution of Tuberculin in phosphate
buffered saline containing
Tween 80 (0.0005%) as a stabilizer. Phenol 0.28% is added as a preservative.
Independent studies conducted by the U. S. Public Health Service
in humans have determined the amount of CT68 in stabilized solution
necessary to produce bio- equivalency with Tuberculin PPD-S (in
phosphate buffer without
Tween 80) using 5 U. S. units (TU) Tuberculin PPD-S as the standard.
Prior to release, each successive lot is tested for potency
in sensitized guinea pigs in comparison with the U. S. Standard
Tuberculin PPD-S distributed by the Office of Biologics, Food and
Drug Administration, Bethesda, Maryland, U. S. A.