สารบัญ

Category Antibacterial.

      Penicillin V Potassium for Oral Solution is a dry mixture of Penicillin V Potassium and one or more suitable buffers, colours, flavours, preservatives, and suspending agents. 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 C₁₆H₁₈N₂O₅S when constituted as directed.

Strengths available 62.5 mg (100,000 Units), 125 mg (200,000 Units) and 250 mg (400,000 Units) (base) per 5 ml.

Dose Adults: 125 to 500 mg every 6 to 8 hours.

      Children: 25 to 50 mg per kg of body weight in divided doses every 6 to 8 hours.

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

Packaging and storage Penicillin V Potassium for Oral Solution 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 the quantity equivalent to the amount of penicillin V.

Identification The retention time of the major peak in the chromatogram obtained from Assay preparation corresponds to that in the chromatogram of Standard preparation, as obtained in the Assay.

pH 5.0 to 7.5, in the solution constituted as directed in the labelling (Appendix 4.11).

Water Not more than 1.0 per cent w/w (Karl Fischer Method, Appendix 4.12).

Deliverable volume Complies with the requirements described under “Deliverable Volume” (Appendix 4.21).

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 under Penicillin V Potassium, p. 141.

      Assay preparation Transfer an accurately measured volume of Penicillin V Potassium for Oral Solution, constituted as directed in the labelling, equivalent to about 250 mg of penicillin V potassium, to a 100-ml volumetric flask, dilute with Mobile phase to volume,and mix. Filter a portion of this solution through a suitable filter of 0.5 μm or finer porosity, and use the filtrate as the Assay preparation.

      Calculation Calculate the content of C₁₆H₁₈N₂O₅S in each ml of the constituted Oral Solution taken, using the declared content of C₁₆H₈N₂O₅S in Penicillin V Potassium RS.

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