Penicillin V Potassium for Oral Solution, chemical structure, molecular formula, Reference Standards

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 90.0percent and not more than 135.0percent 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 Vcontained therein,in addition to or instead of Units,on the basis that 1600Penicillin V Units are equivalent to 1mg of penicillin V.

USP Reference standards á11ñ— USP Penicillin V Potassium RS.

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.

Uniformity of dosage units á905ñ—

FORSOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

Deliverable volume á698ñ: meets the requirements.

pHá791ñ: between 5.0and 7.5,when constituted as directed in the labeling.

Water,Method Iá921ñ: not more than 1.0%.

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.

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