Amoxicillin and Clavulanate Potassium for Oral Suspension
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.
• The retention times of the major peaks of the Sample solution correspond to those of the Standard solution, as obtained in the Assay.
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: Equivalent to 0.5 mg/mL of amoxicillin, from constituted Amoxicillin and Clavulanate Potassium for Oral Suspension in water. Stir by mechanical means for 10 min, and filter. [NoteConstitute as directed in the labeling; use within 1 h. ]
Detector: UV 220 nm
Column: 4-mm × 30-cm; 3- to 10-µm packing L1
Flow rate: 2 mL/min
Injection size: 20 µL
Sample: Standard solution
[NoteThe relative retention times for clavulanic acid and amoxicillin are about 0.5 and 1.0, respectively. ]
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%
Samples: Standard solution and Sample solution
Calculate the percentage of C16H19N3O5S in the Amoxicillin and Clavulanate Potassium for Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × P × F × 100
Calculate the percentage of C8H9NO5 in the Amoxicillin and Clavulanate Potassium for Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × P × 100
Acceptance criteria: 90.0%120.0% of the labeled amount of C16H19N3O5S and 90.0%125.0% of the labeled amount of C8H9NO5
• 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
• pH 791: 3.86.6, in the suspension constituted as directed in the labeling, the test being performed immediately after constitution
• Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62: The total aerobic microbial count does not exceed 102 cfu/g, and the total combined molds and yeasts count does not exceed 5 × 101 cfu/g.
• Packaging and Storage: Preserve in tight containers, at controlled room temperature.
• USP Reference Standards 11
USP Amoxicillin RS
USP Clavulanate Lithium RS
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USP35NF30 Page 2199Pharmacopeial Forum: Volume No. 36(4) Page 899