Amoxicillin and Clavulanate Potassium for Oral Suspension

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

Amoxicillin and Clavulanate Potassium for Oral Suspension contains the equivalent of NLT 90.0% and NMT 120.0% of the labeled amount of amoxicillin (C₁₆H₁₉N₃O₅S) and the equivalent of NLT 90.0% and NMT 125.0% of the labeled amount of clavulanic acid (C₈H₉NO₅). It contains one or more suitable buffers, colors, flavors, preservatives, stabilizers, sweeteners, and suspending agents.

2 IDENTIFICATION

A. The retention times of the major peaks of the Sample solution correspond to those of the Standard solution, as obtained in the Assay.

3 ASSAY

Procedure

Buffer: 7.8 g of monobasic sodium phosphate in 900 mL of water. Adjust with phosphoric acid or 10 N sodium hydroxide to a pH of 4.4 ± 0.1, and dilute with water to 1000 mL.

Mobile phase: Methanol and Buffer (1:19). Pass through a suitable filter.

Standard solution: 0.5 mg/mL of USP Amoxicillin RS and 0.2 mg/mL of USP Clavulanate Lithium RS in water

Sample solution: Nominally 0.5 mg/mL of amoxicillin in water, prepared as follows. Constitute Amoxicillin and Clavulanate Potassium for Oral Suspension with water using the volume specified in the labeling. Stir by mechanical means for 10 min, and filter. Use within 1 h.

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 220 nm

Column: 4-mm × 30-cm; 3- to 10-µm packing L1

Flow rate: 2 mL/min

Injection volume: 20 µL

3.2 System suitability

Sample: Standard solution

[Note—The relative retention times for clavulanic acid and amoxicillin are about 0.5 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 3.5 between the amoxicillin and clavulanic acid peaks

Tailing factor: NMT 1.5 for each analyte peak

Relative standard deviation: NMT 2.0% for each analyte peak

3.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of amoxicillin (C₁₆H₁₉N₃O₅S) in the Amoxicillin and Clavulanate Potassium for Oral Suspension taken:

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

r_U = peak response of amoxicillin from the Sample solution

r_S = peak response of amoxicillin from the Standard solution

C_S = concentration of USP Amoxicillin RS in the Standard solution (mg/mL)

C_U = nominal concentration of amoxicillin in the Sample solution (mg/mL)

P = potency of amoxicillin in USP Amoxicillin RS (µg/mg)

F = conversion factor, 0.001 mg/µg

Calculate the percentage of the labeled amount of clavulanic acid (C₈H₉NO₅) in the Amoxicillin and Clavulanate Potassium for Oral Suspension taken:

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

r_U = peak response of clavulanic acid from the Sample solution

r_S = peak response of clavulanic acid from the Standard solution

C_S = concentration of USP Clavulanate Lithium RS in the Standard solution (mg/mL)

C_U = nominal concentration of clavulanic acid in the Sample solution (mg/mL)

P = potency of clavulanic acid in USP Clavulanate Lithium RS (mg/mg)

Acceptance criteria: 90.0%–120.0% of the labeled amount of amoxicillin (C₁₆H₁₉N₃O₅S) and 90.0%–125.0% of the labeled amount of clavulanic acid (C₈H₉NO₅)

4 PERFORMANCE TESTS

Deliverable Volume 〈698〉

For powder packaged in multiple-unit containers: Meets the requirements

Uniformity of Dosage Units 〈905〉

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

5 SPECIFIC TESTS

pH 〈791〉

Sample solution: Constitute as directed in the labeling, and perform the test immediately after constitution.

Acceptance criteria: 3.8–6.6

Microbial Enumeration Tests 〈61〉andTests for Specified Microorganisms 〈62〉: The total aerobic microbial count does not exceed 103 cfu/g, and the total combined molds and yeasts count does not exceed 102 cfu/g.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers, at controlled room temperature.

USP Reference Standards 〈11〉

USP Amoxicillin RS

USP Clavulanate Lithium RS