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AMOXICILLIN FOR ORAL SUSPENSION

Category Antibacterial.

          Amoxicillin for Oral Suspension contains the equivalent of not less than 90.0 per cent and not more than 120.0 per cent of the labelled amount of C16H19 N3O5S when constituted as directed. It contains one or more suitable buffers, colours, flavours, preservatives, stabilizers, sweeteners, and suspending.

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

Dose Adults and children 20 kg of body weight and over: 250 to 500 mg every 8 hours.
          Infants and children 8 to 20 kg of body weight: 6.7 to 13.3 mg per kg of body weight every 8 hours.
          Infants 6 to 8 kg of body weight: 50 to 100 mg every 8 hours.
          Infants up to 6 kg of body weight: 25 to 50 mg every 8 hours.

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

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

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

Identification 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.

pH 4.0 to 7.5 (Appendix 4.11).

Water Not more than 3.0 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).

          Diluent, Mobile phase, Standard preparation,Chromatographic system, and Procedure Proceed as
directed in the Assay under Amoxicillin, p. 24.
          Assay preparation Dilute an accurately measured volume of Amoxicillin for Oral Suspension, constituted as directed in the labelling, freshly mixed and free from
air bubbles, quantitatively and stepwise in Diluent to obtain a solution containing about 1 mg of anhydrous amoxicillin per ml. 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 each ml of the constituted Oral Suspension taken, using the declared content of C16H19N3O5S in Amoxicillin RS.

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

MONOGRAPHS • AMOXICILLIN FOR ORAL SUSPENSION
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หมายเหตุ / Note : TP II 2011 PAGE 26