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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (T's) » Tuberculin Purified Protein Derivative


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 test dose (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. 3,4,5

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. 6

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