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.
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.
Dissolution 
711
—
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.
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.
Assay—
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.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Penicillin V. Calculate the number of USP Penicillin V Units in the portion of Tablets taken by the formula:
100CP(rU / rS),
in which the terms are as defined therein.
