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AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS

Category Antibacterial.

Amoxicillin and Clavulanate Potassium Tablets contain the equivalent of not less than 90.0 per cent and not more than 120.0 per cent of the labelled amounts of C16H19N3O5S and C8H9NO5.

Strengths available 250, 500 and 875 mg of amoxicillin (anhydrous) with 125 mg of clavulanic acid.

Dose Adults: 250 mg of amoxicillin and 125 mg of clavulanic acid every 8 hours for 7 to 10 days.

Contra-indication; Warning; Precaution; Additional information See under Penicillin V Potassium, p. 140.

Packaging and storage Amoxicillin and Clavulanate Potassium Tablets shall be kept in tightly closed containers, protected from light, and stored at a temperature not exceeding 25º.

Labelling The label on the container states (1) the quantity equivalent to the amount of amoxicillin; (2) the quantity equivalent to the amount of clavulanic acid.

Identification The retention times of the major peaks in the chromatogram of the Assay preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the Assay.

Water Not more than 7.5 per cent w/w where the labelled amount of amoxicillin in each tablet is 250 mg or less; not more than 10.0 per cent w/w where the labelled amount of amoxicillin in each tablet is more than 250 mg but less than or equal to 500 mg; not more than 11.0 per cent w/w where the labelled amount of amoxicillin in each tablet is more than 500 mg (Karl Fischer Method, Appendix 4.12).

Dissolution Carry out the test as described in the “Dissolution Test” (Appendix 4.24). (Note Tablets labelled for veterinary use only are exempt from this requirement.)
          Dissolution Medium: water; 900 ml.
          Apparatus 2: 75 rpm.
          Time: 30 minutes.
          Procedure Determine the amount of C16H19N3O5S and C8H9NO5 dissolved, employing the procedure set forth in the Assay making any necessary volumetric adjustments.
          Tolerances Not less than 85 per cent (Q) of the labelled amount of C16H19N3O5S and not less than 80 per cent (Q) of the labelled amount of C8H9NO5 are dissolved in 30 minutes.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).
          pH 4.4 Sodium phosphate buffer, Mobile phase, Standard preparation and Chromatographic system Proceed as directed in the Assay under Amoxicillin and Clavulanate Potassium for Oral Suspension, p. 26.
          Assay preparation Dissolve not less than 10 Amoxicillin and Clavulanate Potassium Tablets, accurately counted, in water with the aid of mechanical stirring, transfer to a suitable volumetric flask, dilute with water to volume, and mix. Filter a portion of this solution, discarding the first 10 ml of the filtrate. Dilute an accurately measured volume of the filtrate quantitatively and stepwise with water to obtain a solution containing about 0.5 mg of amoxicillin per ml. Use this Assay preparation within 1 hour.

          Procedure Proceed as directed under Procedure in the Assay under Amoxicillin and Clavulanate Potassium for Oral Suspension, p. 26.
          Calculation Calculate the contents of amoxicillin (C16H19N3O5S) and of clavulanic acid (C8H9NO5) in the Tablets taken, using the declared content of C16H19N3O5S in Amoxicillin RS and the declared content of C8H9NO5 in Clavulanate Lithium RS.

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

MONOGRAPHS • AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS
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หมายเหตุ / Note : TP II 2011 PAGE 27 - 28