TUBERSOL Solution for injection Ref.[11095] Active ingredients: Tuberculin

TUBERSOL Tuberculin Purified Protein Derivative (Mantoux) (PPD) (1) for intradermal tuberculin testing is prepared from a large Master Batch Connaught Tuberculin (CT68) (2) and is a cell-free purified protein fraction obtained from a human strain of Mycobacterium tuberculosis grown on a protein-free synthetic medium and inactivated. (2) The use of a standard preparation derived from a single batch (CT68) has been adopted in order to eliminate batch to batch variation by the same manufacturer. (2)

TUBERSOL is a clear, colorless liquid.

TUBERSOL contains:

Purified protein derivative of M. tuberculosis: 5 TU per 0.1 mL
Polysorbate 80: 0.0006%
Phenol: 0.22% to 0.35% w/v in sterile isotonic phosphate buffered saline

Before release, each successive lot is tested for potency in comparison with the US Standard Tuberculin PPD-S. (3)

Independent studies conducted by the US Public Health Service in humans have determined the amount of CT68 in stabilized solution necessary (4) (5) (6) to produce bio-equivalency with Tuberculin PPD-S (in phosphate buffer without polysorbate 80) using 5 US units (TU) Tuberculin PPD-S as the standard.