Penicillin V Potassium, chemical structure, molecular formula, Reference Standards

Penicillin V Potassium

C16H17KN2O5S 388.48

4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-[6-(phenoxyacetyl)amino]-,monopotassium salt,[2S-(2a,5a,6b)]-.

Monopotassium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate [132-98-9].

»Penicillin V Potassium has a potency of not less than 1380and not more than 1610Penicillin V Units per mg.

Packaging and storage— Preserve in tight containers.

Labeling— Label it to indicate that it is to be used in the manufacture of nonparenteral drugs only.

USP Reference standards á11ñ— USP Penicillin V Potassium RS.

Identification—

A: Infrared Absorption á197Kñ.

B: It responds to the flame test for Potassium á191ñ.

Specific rotation á781Sñ: between +220

and +235

Test solution: 10mg per mL,in carbon dioxide-free water.

Crystallinity á695ñ: meets the requirements.

pHá791ñ: between 4.0and 7.5,in a solution containing 30mg per mL.

Loss on drying á731ñ— Dry about 100mg in a capillary-stoppered bottle in vacuum at 60

for 3hours:it loses not more than 1.5%of its weight.

Phenoxyacetic acid—

Diluent,Mobile phase,Standard solution,and Chromatographic system— Proceed as directed in the test for Phenoxyacetic acidunder Penicillin V.

Test solution— Dissolve an accurately weighed quantity of Penicillin V Potassium quantitatively in Diluentto obtain a solution containing 20.0mg per mL.[NOTE—Use this solution on the day prepared.]

Procedure— Proceed as directed for Procedurein the test for Phenoxyacetic acidunder Penicillin V.Calculate the percentage of phenoxyacetic acid in the portion of Penicillin V Potassium taken by the formula:

5C(rU/rS),

in which Cis the concentration,in mg per mL,of phenoxyacetic acid in the Standard solution,and rUand rSare the phenoxyacetic acid peak responses obtained from the Test solutionand the Standard solution,respectively.Not more than 0.5%is found.

Limit of p-hydroxypenicillin V— Using the chromatogram of the Assay preparationobtained as directed in the Assay,calculate the percentage of p-hydroxypenicillin Vin the portion of Penicillin V Potassium taken by the formula:

100rp/rU,

in which rpis the p-hydroxypenicillin Vpeak response,and rUis the sum of the p-hydroxypenicillin Vand penicillin Vpeak responses:not more than 5.0%is found.

Assay—

Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder Penicillin V.

Assay preparation— Transfer about 125mg of Penicillin V Potassium,accurately weighed,to a 50-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.

Procedure— Proceed as directed for Procedurein the Assayunder Penicillin V.Calculate the quantity,in USP Penicillin V Units,in each mg of the Penicillin V Potassium taken by the formula:

50(CP/WU)(rU/rS),

in which WUis the weight,in mg,of Penicillin V Potassium taken to prepare the Assay preparation,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 1499

Phone Number:1-301-816-8335