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Category Antibacterial; antiprotozoal.

      Tetracycline Hydrochloride Tablets contain not less than 90.0 per cent and not more than 125.0 per cent of the labelled amount of C₂₂H₂₄N₂O₈.HCl.

Strengths available 250 and 500 mg.

Dose Adults: 250 to 500 mg every 6 hours or up to 4 g daily.

      Children over 8 years of age: 25 to 50 mg per kg of body weight in four divided doses.

Contra-indication; Warning; Precaution; Additional information See under Tetracycline Hydrochloride, p. 157.

Packaging and storage See under Tetracycline Hydrochloride Capsules, p. 159.

Identification Comply with the tests described under Tetracycline Hydrochloride Capsules, p 141.

Loss on drying Not more than 3.0 per cent w/w after drying about 100 mg at 60º at a pressure not exceeding 0.7 kPa (about 5 Torr) for 3 hours (Appendix 4.15).

4-Epianhydrotetracycline Not more than 3 per cent w/w. Proceed as directed in the 4- Epianhydrotetracycline under Tetracycline Hydrochloride, p. 158.

Dissolution Carry out the test as described in the “Dissolution Test” (Appendix 4.24).

      Dissolution medium: water; 900 ml.

      Apparatus 2: 75 rpm. Maintain a distance of 45±5 mm between the blade and the inside bottom of the vessel.

      Time: 60 minutes.

      Procedure Determine the amount of C₂₂H₂₄N₂O₈.HCl dissolved from absorbances at the maximum at about 276 nm of filtered portions of the test solution, suitably diluted with Dissolution medium, if necessary, in comparison with a standard solution having a known concentration of Tetracycline Hydrochloride RS in the same medium (Appendix 2.2).

      Tolerances Not less than 80 per cent (Q) of the labelled amount of C₂₂H₂₄N₂O₈.HCl is dissolved in 60 minutes.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).

      Diluting solvent, Mobile phase, Resolutionsolution, Standard preparation, Chromatographic system, and Procedure Proceed as directed in the Assay described under Tetracycline Hydrochloride, p. 158.

      Assay preparation Weigh and finely powder not less than 20 Tetracycline Hydrochloride Tablets. Transfer an accurately weighed portion of the powder, containing about 50 mg of tetracycline hydrochloride, to a 100-ml volumetric flask, add 50 ml of Diluting solvent, mix, and sonicate for 5 minutes. Allow to cool, add Diluting solvent to volume, mix, and filter.

      Calculation Calculate the content of C₂₂H₂₄N₂O₈.HCl in the Tablets taken, using the declared content of C₂₂H₂₄N₂O₈.HCl in Tetracycline Hydrochloride RS.

Other requirements Comply with the requirements described under “Tablets” (Appendix 1.16)