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Category Antibacterial; antiprotozoal.

      Tetracycline Hydrochloride Capsules 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 Tetracycline Hydrochloride Capsules shall be kept in tightly closed containers, protected from light.

Identification

      A. The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

      B. To a portion of the capsule contents, containing 10 mg of tetracycline hydrochloride, add 20 ml of warm ethanol, allow to stand for 20 minutes, filter, and evaporate the filtrate to dryness on a water-bath. To 0.5 mg of the residue add 2 ml of sulfuric acid: a purplish red colour is produced. Add 1 ml of water: the colour changes to deep yellow.

      C. The residue obtained in test B yields the reactions characteristic of chlorides (Appendix 5.1). 

Loss on drying Not more than 4.0 per cent w/w after drying about 100 mg in a capillary-stoppered bottle 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. 139.

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 for 250-mg capsules; 90 minutes for 500-mg capsules.

      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 for 250-mg capsules; 90 minutes for 500-mg capsules.

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. 157.

      Assay preparation Remove, as completely as possible, the contents of not less than 20 Tetracycline Hydrochloride Capsules, and weigh accurately. Mix the combined contents, and transfer an accurately weighed portion of the freshly mixed 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 Capsules taken, using the declared content of C₂₂H₂₄N₂O₈.HCl in Tetracycline Hydrochloride RS.

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