Penicillin V Potassium Tablets

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

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

DOWNLOAD PDF HERE

1 DEFINITION

Penicillin V Potassium Tablets contain NLT 90.0% and NMT 120.0% of the labeled number of Penicillin V Units.

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: Transfer a portion of finely powdered Tablets (NLT 20), containing nominally about 400,000 Penicillin V Units, to a suitable volumetric flask. Dilute with Mobile phase to volume, mix to obtain a solution containing nominally about 4000 Penicillin V Units/mL and shake for about 5 min. 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% for penicillin V potassium, 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 Tablets 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%–120.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Apparatus 2: 50 rpm

Time: 45 min

Standard solution: USP Penicillin V Potassium RS in Medium

Sample solution: Sample per Dissolution 〈711〉. Dilute with Medium to a concentration that is similar to the Standard solution. Analysis: Determine the percentage of the labeled number of Penicillin V Units dissolved by a suitable validated spectrophotometric analysis of a ltered portion of the solution under test.

Tolerances: NLT 75% (Q) of the labeled number of Penicillin V Units is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 SPECIFIC TESTS

Loss on Drying 〈731〉

Sample: 100 mg

Analysis: Dry the Sample in a capillary-stoppered bottle under vacuum at 60° for 3 h.

Acceptance criteria: NMT 1.5%

6 ADDITIONAL REQUIREMENTS

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 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