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Tubersol

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Tubersol

Tubersol®
Diagnostic Antigen

Tuberculin Purified Protein Derivative (Mantoux)

DRUG DESCRIPTION

Tuberculin Purified Protein Derivative1 (Mantoux) - TUBERSOL (tuberculin purified protein) ® for intradermal (Mantoux) tuberculin testing is available in a stabilized solution bio-equivalent to 5 U.S. units (TU) PPD-S per test dose (0.1 mL).

TUBERSOL (tuberculin purified protein) ® is prepared by Aventis Pasteur Limited from a large Master Batch, Connaught Tuberculin (CT68) 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

TUBERSOL (tuberculin purified protein) ® 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

Prior to release, each successive lot is tested for potency in sensitized guinea pigs in comparison with the U.S. Standard Tuberculin PPD-S.6

REFERENCES

1. Landi S.Preparation, purification, and stability of tuberculin. Appl Microbiol 1963;11:408-412.

2. Landi S. et al. Preparation and characterization of a large batch of tuberculin purified protein derivative (PPD-CT68). Ann Scalvo.1980;22:889-907.

3. Landi S, et al.Adsorption of tuberculin PPD to glass and plastic surfaces. Bull.WHO 1966;35:593-602.

4. Landi S, et al.Disparity of potency between stabilized and nonstabilized dilute tuberculin solutions. Am Rev Respir Dis 1971;104:385-393.

5. Landi S, et al.Stability of dilute solutions of tuberculin purified protein derivative. Tubercle 1978;59:121-133.

6. U.S.Code of Federal Regulations,Title 21, Part 650, Subpart B - tuberculin.

Last reviewed on RxList: 1/30/2009
This monograph has been modified to include the generic and brand name in many instances.

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