Penicillin V Potassium for Oral Solution
» Penicillin V Potassium for Oral Solution is a dry mixture of Penicillin V Potassium with or without one or more suitable buffers, colors, flavors, preservatives, and suspending agents. It contains not less than 90.0 percent and not more than 135.0 percent of the labeled number of Penicillin V Units when constituted as directed.
Packaging and storage Preserve in tight containers.
Labeling It 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.
Uniformity of dosage units 905
For solid packaged in single-unit containers: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 5.0 and 7.5, when constituted as directed in the labeling.
Water, Method I 921: not more than 1.0%.
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Proceed as directed in the Assay under Penicillin V.
Assay preparation Transfer an accurately measured volume of Penicillin V Potassium for Oral Solution, constituted as directed in the labeling, equivalent to about 400,000 USP Penicillin V Units, to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. 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 each mL of the constituted Penicillin V Potassium for Oral Solution taken by the formula:
100(CP / V)(rU / rS)in which V is the volume, in mL, of constituted Penicillin V Potassium for Oral Suspension taken, and the other terms are as defined therein.
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USP35NF30 Page 4255