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Category Antibacterial (second-generation cephalosporin).

Cefaclor for Oral Suspension is a dry mixture of cefaclor and one or more suitable buffers, colours, diluents, and flavours. It contains the equivalent of not less than 90.0 per cent and not more than 120.0 per cent of the labelled amount of C₁₅H₁₄ClN₃O₄.

Strengths available 125, 187, 250, and 375 mg (base) per 5 ml.

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 for Oral Suspension shall be kept in tightly closed containers and stored at a temperature not exceeding 30º. After constitution, it be used within the period stated on the label.

Identification
          A. Shake a quantity of the oral suspension containing the equivalent of 300 mg of cefaclor with 500 ml of water, filter and use the filtrate. 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 tothat in the chromatogram of the Standard preparation,
as obtained in the Assay.

pH 2.5 to 5.0, in the suspension constituted as directed in the labelling (Appendix 4.11).

Water Not more than 2.0 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 Constitute a container of Cefaclor for Oral Suspension as directed in the labelling. Transfer an accurately measured volume of the resulting suspension, freshly mixed and free from air bubbles, dilute quantitatively with Mobile phase to obtain a final solution containing about 300 μg of cefaclor per ml. Sonicate if necessary to ensure complete dissolution of the cefaclor. Filter to obtain clear Assay preparation.
          Calculation Calculate the content of C₁₅H₁₄ClN₃O₄S, in the portion of the Oral Suspension taken, using the declared content of C₁₅H₁₄ClN₃O₄S in Cefaclor RS.

Other requirements Complies with the requirements described under “Oral Liquids” (Appendix 1.16).