Packaging and storage—
Preserve in tight containers.
Labeling—
It may be labeled in terms of the weight of penicillin Vcontained therein,in addition to or instead of Units,on the basis that 1600Penicillin V Units are equivalent to 1mg of penicillin V.
Identification—
The retention time of the penicillin Vpeak in the chromatogram of the
Assay preparationcorresponds to that in the chromatogram of the
Standard preparation,as obtained in the
Assay.
pHá791ñ:
between 5.0and 7.5,when constituted as directed in the labeling.
Assay—
Mobile phase,Standard preparation,Resolution solution,and Chromatographic system—
Proceed as directed in the
Assayunder
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 400,000USP Penicillin V Units,to a 100-mLvolumetric flask,dilute with Mobile phaseto 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
Procedurein the
Assayunder
Penicillin V.Calculate the number of USP Penicillin V Units in each mLof the constituted Penicillin V Potassium for Oral Solution taken by the formula:
100(CP/V)(rU/rS),
in which
Vis the volume,in mL,of constituted Penicillin V Potassium for Oral Suspension taken,and the other terms are as defined therein.