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Category Antibacterial.

          Amoxicillin 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 C₁₆H₁₉N₃O₅S.

Strengths available 250 and 500 mg (anhydrous).

Dose Adults: 250 to 500 mg every 8 hours, or 500 to 1000 mg every 12 hours.

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

Pakaging and storage Amoxicillin Capsules shall be kept in tightly closed containers.

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

Identification
          A. The infrared absorption spectrum of the capsule contents is concordant with the spectrum obtained from Amoxicillin RS (Appendix 2.1) or with the reference spectrum of Amoxicillin.
          B. Comply with the tests for Identification B, C and D described under Amoxicillin, p. 24.

Water Not more than 14.5 per cent w/w (Karl Fischer Method, Appendix 4.12).

Dissolution Carry out the test as described in the “Dissolution Test” (Appendix 4.24).
          Dissolution medium: water; 900 ml.
          Apparatus 1: 100 rpm.
          Time: 60 minutes.
          Procedure Determine the amount of C₁₆H₁₉N₃O₅S dissolved from absorbances at the maximum at about 272 nm of filtered portions of the test solution, suitably diluted with water, if necessary, in comparison with a standard solution having a known concentration of Amoxicillin RS in the same medium (Appendix 2.2).
          Tolerances Not less than 80 per cent (Q) of the labelled amount of C₁₆H₁₉N₃O₅S is dissolved in 60 minutes.

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

          Diluent, Mobile phase, Standard preparation, Chromatographic system, and Procedure Proceed as directed in the Assay under Amoxicillin, p. 24.
          Assay preparation Remove as completely as possible, the contents of not less than 20 Amoxicillin Capsules and weigh accurately. Mix the combined contents, and transfer an accurately weighed quantity,containing about 200 mg of anhydrous amoxicillin, to a 200-ml volumetric flask, add Diluent to volume and mix. Sonicate if necessary to ensure complete dissolution. Filter a portion of this solution through a suitable filter of 1-μm or finer porosity, and use the filtrate as Assay preparation. Use this solution within 6 hours.
          Calculation Calculate the content of C₁₆H₁₉N₃O₅S in the Capsules taken, using the declared content of C₁₆H₁₉N₃O₅S in Amoxicillin RS.

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