Penicillin V Potassium Tablets
»Penicillin V Potassium Tablets contain not less than 90.0percent and not more than 120.0percent 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 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.
Dissolution á711ñ—
Medium: pH6.0phosphate buffer (see Buffer Solutionsin the section Reagents,Indicators,and Solutions);900mL.
Apparatus 2: 50rpm.
Time: 45minutes.
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 RSin 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 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Loss on drying á731ñ— Dry about 100mg in a capillary-stoppered bottle in vacuum at 60for 3hours: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 Assayunder Penicillin V.
Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 400,000USP Penicillin V Units,to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and shake for about 5minutes.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 the portion of Tablets taken by the formula:
100CP(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1500
Phone Number:1-301-816-8335