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CEFADROXIL FOR ORAL SUSPENSION

Category Antibacterial (first-generation cephalosporin).

Cefadroxil for Oral Suspension is a dry mixture of cefadroxil 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 C16H17N3O5S.

Strengths available 125, 250 and 500 mg (anhydrous) per 5 ml.

Dose Adults: 1 to 2 g daily as a single dose or in two divided doses.
          Children: 30 mg per kg of body weight as a single dose or in two divided doses.

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

Additional information See under Cefadroxil, p. 37.

Packaging and storage Cefadroxil for Oral Suspension shall be kept in tightly closed containers. After constitution, it should be used within the period stated on the label.

Labelling The label on the container states (1) the quantity equivalent to the amount of anhydrous cefadroxil; (2) whether it is in the monohydrate o hemihydrate form.

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. Carry out the test as described in the “Thin-layer Chromatography” (Appendix 3.1), using silica gel H as the coating substance and a mixture of 3 volumes of a 6.7 per cent w/v solution of ninhydrin in acetone, 80 volumes of 0.1 M disodium hydrogenphosphate and 120 volumes of 0.1 M citric acid as the mobile phase. Impregnate the plate by development with a 5 per cent v/v solution of n-tetradecane in hexane. Allow the solvent to evaporate and carry out the chromatography in the same direction as the impregnation. Apply separately to the plate, 20 μl of each of the following solutions. For solution (A) dilute a volume of the oral suspension containing 200 mg of cefadroxil to 100 ml with water, filter and use the filtrate. Solution (B) contains 0.2 per cent w/v of Cefadroxil RS in water. After removal of the plate, allow it to dry in air, spray with a 0.2 per cent w/v solution of ninhydrin in absolute ethanol, heat the plate at 110º for 10 minutes and allow it to dry in air. The principal spot in the chromatogram obtained from solution (A) is similar in position and size to that in the chromatogram obtained from solution (B).

pH 4.5 to 6.0, in the suspension constituted as directed in the labelling (Appendix 4.11).

Water Not more than 2.0 per cent w/w (Karl FischerMethod, Appendix 4.12).

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

          Mobile phase, Resolution solution, Chromatographic system and Procedure Proceed as directed in the Assay described under Cefadroxil, p 38.
          Buffer phosphate solution and Standard preparation Proceed as directed in the Assay described under Cefadroxil Capsules, p 20.
          Assay preparation Constitute a container of Cefadroxil for Oral Suspension as directed in the labelling. Transfer an accurately measured volume of the resulting suspension, containing about 250 mg of cefadroxil, to a 250-ml volumetric flask, dilute with Buffer phosphate solution, stir by mechanical means for 5 minutes. Dilute with the same solvent to volume and filter. (Note this solution on the day prepared.)
          Calculation Calculate the content of C16H17N3O5S, in the portion of the constituted Oral Suspension taken, using the declared content of C16H17N3O5S in Cefadroxil RS.

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

MONOGRAPHS • CEFADROXIL FOR ORAL SUSPENSION
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หมายเหตุ / Note : TP II 2011 PAGE 39 - 40