Penicillin V Tablets
» Penicillin V 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
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
Medium:
water; 900 mL.
Apparatus 2:
50 rpm.
Time:
45 minutes.
Procedure
Determine the amount of penicillin V (C16H18N2O5S) 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 having a known concentration of USP Penicillin V Potassium RS in the same medium.
Tolerances
Not less than 75% (Q) of the labeled amount of C16H18N2O5S is dissolved in 45 minutes.
Uniformity of dosage units 905:
meet the requirements.
Water, Method I 921:
not more than 3.0%.
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 of 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.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4253
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