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Category Antibacterial (second-generation cephalosporin).

Cefaclor Capsules contain the equivalent of not less than 90.0 per cent and not more than 120.0 per cent of the labelled amount of C₁₅H₁₄ClN₃O₄S.

Strengths available 250 and 500 mg (base).

Dose Adults: 250 to 500 mg every 8 hours. The maximum total dose should not exceed 4 g a day.
          Children: 20 mg per kg of body weight daily in equally divided doses every 8 hours, for severe infections, this dosage may be doubled. The maximum total dose should not exceed 1 g a day.

Contra-indication; Warning; Additional information See under Cefaclor, p. 33.

Packaging and storage Cefaclor Capsules shall be kept in tightly closed containers.

Identification
          A. Shake a quantity of the contents of the capsules containing the equivalent of 300 mg of cefaclor with 100 ml of water, filter and dilute 1 ml of the filtrate to 100 ml of water. The ultraviolet absorption spectrum of the resulting solution, when observed between 190 nm to 310 nm, exhibits a maximum only at 264 nm (Appendix 2.2).
          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.

Dissolution Carry out the test as described in the “Dissolution Test” (Appendix 4.24).
          Dissolution medium: water, 900 ml.
          Apparatus 2: 50 rpm.
          Time: 30 minutes.
          Procedure Determine the amount of C₁₅H₁₄ClN₃O₄S dissolved from absorbances at the maximum at about 264 nm of filtered portions of the test solution, suitably diluted with water, in comparison with a standard solution having a known concentration of Cefaclor RS in the same medium (Appendix 2.2).
          Tolerance Not less than 80 per cent (Q) of the labelled amount of C₁₅H₁₄ClN₃O₄S is dissolved in 30 minutes.

Water Not more than 8.0 per cent w/w (Karl Fischer Method, Appendix 4.12).

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

          Mobile phase, Resolution solution, Standard preparation, Chromatographic system and Procedure Proceed as directed in the Assay described under Cefaclor, p. 34.
          Assay preparation Remove, as completely as possible, the contents of not less than 20 Cefaclor Capsules, and weigh accurately. Mix the combined contents, and transfer an accurately weighed portion of the powder, containing about 75 mg of cefaclor, to a 250-ml volumetric flask, dilute with Mobile phase to volume, mix and filter.
 Calculate the content of C₁₅H₁₄ClN₃O₄S, in the portion of the Capsules taken, using the declared content of C₁₅H₁₄ClN₃O₄S in Cefaclor RS.

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