Penicillin V Potassium Tablets
» Penicillin V Potassium Tablets contain not less than 90.0 percent and not more than 120.0 percent of the labeled number of Penicillin V Units.
Packaging and storage Preserve in tight containers.
Labeling Label the chewable Tablets to indicate that they are to be chewed before swallowing. The Tablets may be labeled in terms of the weight of penicillin V contained therein, in addition to or instead of Units, on the basis that 1600 Penicillin V Units are equivalent to 1 mg of penicillin V.
USP Reference standards 11
Identification The retention time of the penicillin V peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Medium: pH 6.0 phosphate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions); 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Procedure Determine the amount of Penicillin V Units by a suitable validated spectrophotometric analysis of a filtered portion of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution of USP Penicillin V Potassium RS in the same medium having a known concentration of Penicillin V Units.
Tolerances Not less than 75% (Q) of the labeled amount of Penicillin V Units is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Loss on drying 731 Dry about 100 mg in a capillary-stoppered bottle in vacuum at 60 for 3 hours: it loses not more than 1.5% of its weight.
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Proceed as directed in the Assay under Penicillin V.
Assay preparation Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 400,000 USP Penicillin V Units, 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 having a 0.5-µm or finer porosity, and use the filtrate as the Assay preparation.
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USP35NF30 Page 4256