Penicillin V Potassium
(pen'' i sil' in poe tas' ee um).
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388.484-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-[6-(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2
,5,6
)]-.
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 1380 and not more than 1610 Penicillin 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 
11
—
11—
USP Penicillin V Potassium RS 
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Specific rotation 781S:
between +220
and +235.
781S:
between +220 and +235.
Test solution:
10 mg per mL, in carbon dioxide-free water.
Crystallinity 695:
meets the requirements.
695:
meets the requirements.
pH 791:
between 4.0 and 7.5, in a solution containing 30 mg per mL.
791:
between 4.0 and 7.5, in a solution containing 30 mg per mL.
Loss on drying 731—
Dry about 100 mg in a capillary-stoppered bottle in vacuum at 60 for 3 hours: it loses not more than 1.5% of its weight.
731—
Dry about 100 mg in a capillary-stoppered bottle in vacuum at 60 for 3 hours: 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 acid under Penicillin V.
Test solution—
Dissolve an accurately weighed quantity of Penicillin V Potassium quantitatively in Diluent to obtain a solution containing 20.0 mg per mL. [note—Use this solution on the day prepared. ]
Procedure—
Proceed as directed for Procedure in the test for Phenoxyacetic acid under Penicillin V. Calculate the percentage of phenoxyacetic acid in the portion of Penicillin V Potassium taken by the formula:
5C(rU / rS)
in which C is the concentration, in mg per mL, of phenoxyacetic acid in the Standard solution, and rU and rS are the phenoxyacetic acid peak responses obtained from the Test solution and the Standard solution, respectively. Not more than 0.5% is found.
Limit of p-hydroxypenicillin V—
Using the chromatogram of the Assay preparation obtained as directed in the Assay, calculate the percentage of p-hydroxypenicillin V in the portion of Penicillin V Potassium taken by the formula:
100rp / rU
in which rp is the p-hydroxypenicillin V peak response, and rU is the sum of the p-hydroxypenicillin V and penicillin V peak responses: not more than 5.0% is found.
Assay—
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—
Proceed as directed in the Assay under Penicillin V.
Assay preparation—
Transfer about 125 mg of Penicillin V Potassium, accurately weighed, to a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure—
Proceed as directed for Procedure in the Assay under 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 WU is the weight, in mg, of Penicillin V Potassium taken to prepare the Assay preparation, and the other terms are as defined therein.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4255