Penicillin V Potassium for Oral Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

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 NLT 90.0% and NMT 135.0% of the labeled number of Penicillin V Units when constituted as directed.

2 IDENTIFICATION

A. The retention time of the penicillin V peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

Procedure

Mobile phase: Acetonitrile, glacial acetic acid, and water (350:5.75:650)

System suitability solution: 2.5 mg/mL each of USP Penicillin G Potassium RS and USP Penicillin V Potassium RS in Mobile phase

Standard solution: 2.5 mg/mL of USP Penicillin V Potassium RS in Mobile phase

Sample solution: Constitute Penicillin V Potassium for Oral Solution as directed in the labeling. Transfer a suitable aliquot containing nominally 400,000 Penicillin V Units to a suitable volumetric ask. Dilute with Mobile phase to volume, and mix to obtain a solution containing nominally 4000 Penicillin V Units/mL. Pass a portion of this solution through a suitable filter of 0.5-µm or finer pore size.

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4-mm × 30-cm; packing L1

Flow rate: 1 mL/min

Injection volume: 10 µL

3.2 System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times for p-hydroxypenicillin V, penicillin G, and penicillin V are about 0.4, 0.8, and 1.0, respectively.] Suitability requirements

Resolution: NLT 3.0 between penicillin G and penicillin V, System suitability solution

Column efficiency: NLT 1800 theoretical plates, System suitability solution

Relative standard deviation: NMT 1.0%, Standard solution

3.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled number of Penicillin V Units in the portion of Penicillin V Potassium for Oral Solution taken:

Result = (r_U /r_S ) × (C_S /C_U ) × P × 100

r_U = sum of the peak responses of p-hydroxypenicillin V and penicillin V from the Sample solution

r_S = sum of the peak responses of p-hydroxypenicillin V and penicillin V from the Standard solution

C_S = concentration of USP Penicillin V Potassium RS in the Standard solution (mg/mL)

C_U = nominal concentration of penicillin V in the Sample solution (Penicillin V Units/mL)

P = potency of penicillin V in USP Penicillin V Potassium RS (Penicillin V Units/mg)

Acceptance criteria: 90.0%–135.0%

4 PERFORMANCE TESTS

Uniformity of Dosage Units 〈905〉

For solids packaged in single-unit containers: Meets the requirements

Deliverable Volume 〈698〉: Meets the requirements

5 SPECIFIC TESTS

pH 〈791〉

Sample solution: Constitute as directed in the labeling.

Acceptance criteria: 5.0–7.5

Water Determination 〈921〉, Method I: NMT 1.0%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

Labeling: It may be labeled in terms of the weight of penicillin V contained therein, in addition to or instead of Units, on the basis that 1600 Penicillin V Units are equivalent to 1 mg of penicillin V.

USP Reference Standards 〈11〉

USP Penicillin G Potassium RS

USP Penicillin V Potassium RS