May 1, 2016
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Tubersol

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Tubersol

TUBERSOL®
Tuberculin Purified Protein Derivative
(Mantoux) Diagnostic Antigen (Aid in the detection of infection with Mycobacterium tuberculosis)

FOR INTRADERMAL USE

Polysorbate 80 Stabilized Solution of Tuberculin Purified Protein Derivative for Tuberculin Testing in Humans

DRUG DESCRIPTION

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.

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 US Code of Federal Regulations, Title 21, Part 610, Subpart C - Standard preparations and limits of potency.

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

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

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

Last reviewed on RxList: 2/5/2016
This monograph has been modified to include the generic and brand name in many instances.

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