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PENICILLIN V POTASSIUM TABLETS

Category Antibacterial.

      Penicillin V Potassium Tablets contain the equivalent of not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of C16H18N2O5S.

Strengths available 125 mg (200,000 Units), 250 mg (400,000 Units) and 500 mg (800,000 Units) (base).

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 Tablets shall be kept in tightly closed containers.

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 of the Assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the Assay.

Dissolution Carry out the test as described in the “Dissolution Test” (Appendix 4.24).

      Dissolution medium: Use phosphate buffer pH 6.0 prepared as directed in phosphate buffers; 900 ml.

      Apparatus 2: 50 rpm.

      Time: 45 minutes.

      Procedure determine the amount of C16H18N2O5 S of filtered portions of the test solution, suitably diluted with Dissolution medium, if necessary, as described in the Assay in comparison with a standard solution having a known concentration of Penicillin V Potassium RS in the same medium.

      Tolerances Not less than 75 per cent (Q) of the labelled amount of C16H18N2O5 S is dissolved in 45 minutes.

Loss on drying Not more than 1.5 per cent w/w after drying at 60º at a pressure not exceeding 0.7 kPa (about 5 Torr) for 3 hours (Appendix 4.15).

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 Weigh and finely powder not less than 20 Penicillin V Potassium Tablets. Transfer an accurately weighed portion of the powder, containing about 250 mg of penicillin V, to a 100-ml volumetric flask, dilute with Mobile phase to volume, and shake for about 5 minutes. 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 a portion of the Tablets taken, using the declared content of C16H18N2O5S in Penicillin V Potassium RS.

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

MONOGRAPHS • PENICILLIN V POTASSIUM TABLETS
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หมายเหตุ / Note : TP II 2011 PAGE 142-143