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CEPHALEXIN TABLETS

Category Antibacterial (first-generation cephalosporin).

          Cephalexin Tablets contain the equivalent of not less than 90.0 per cent and not more than 120.0 per cent of the labelled amount of C16H17N3O4S. Strengths available 250, 500 mg and 1 g (anhydrous).

Dose Adults: 1 to 4 g daily in divided doses every 6 hours.
          Children: 25 to 50 mg per kg of body weight daily in divided doses every 6 hours. For severe infections, these dosages may be doubled.

Contra-indication; Warning; Precaution; Additional information See under Cephalexin, p. 58.

Packaging and storage Cephalexin Tablets shall be kept in tightly closed containers, protected from light.

Labelling The label on the container states the quantity equivalent to the amount of anhydrous cephalexin.

Identification
          A. Remove any coating. Shake a portion of the powdered tablet cores, equivalent to about 500 mg of cephalexin, with 1 ml of water and 1.4 ml of 1 M hydrochloric acid, add 100 mg of decolourizing charcoal. Shake, filter and wash the filter with 1 ml of water. Add slowly to the filtrate a saturated solution of sodium acetate until precipitate occurs. Add 5 ml of methanol, filter and wash the precipitate with two 1-ml portions of methanol. The residue, after drying at a pressure not exceeding 0.7 kPa (about 5 Torr), complies with the tests for Identification described under Cephalexin, p 58.
          B. 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.

Water Not more than 9.0 per cent w/w where Tablets contain Cephalexin (Karl Fischer Method, Appendix 4.12).

Dissolution Carry out the test as described in the “Dissolution Tests” (Appendix 4.24).
          Dissolution medium: water; 900 ml.
          Apparatus 1: 100 rpm.
          Time: 30 minutes.
          Procedure Determine the amount of C16H17N3O4S dissolved from absorbances at the maximum at about 262 nm of filtered portions of the test solution, suitably diluted with Dissolution medium, if necessary, to a concentration of about 20 μg per ml, in comparison with a standard solution having a known concentration of Cephalexin RS in the same medium (Appendix 2.2).

         Tolerances Not less than 80 per cent (Q) of the labelled amount of C16H17N3O4S is dissolved in 30 minutes.
          Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).
          Mobile phase, Standard preparation, Chromatographic system and Procedure Proceed as directed in the Assay under Cephalexin, p 60.
          Assay preparation Weigh and finely powder not less than 20 Cephalexin Tablets. Transfer an accurately weighed portion of the powder, containing about 250 mg of cephalexin, to a 250-ml volumetric flask. Add 100 ml of water and shake for 30 minutes. Adjust to volume with water and filter. Dilute 25.0 ml of the filtrate to 50.0 ml with water.
          Calculation Calculate the content of C16H17N3O4S, in a portion of the Tablets taken, using the declared content of C16H17N3O4S in Cephalexin RS.

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

 

MONOGRAPHS • CEPHALEXIN TABLETS
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หมายเหตุ / Note : TP II 2011 PAGE 62