Amoxicillin and Clavulanate Potassium for Oral Suspension
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.
IDENTIFICATION
• The retention times of the major peaks of the Sample solution correspond to those of the Standard solution, as obtained in the Assay.
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:
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. [Note—Constitute as directed in the labeling; use within 1 h. ]
Chromatographic system
Mode:
LC
Detector:
UV 220 nm
Column:
4-mm × 30-cm; 3- to 10-µm packing L1
Flow rate:
2 mL/min
Injection size:
20 µL
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%
Analysis
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
| rU | = | = peak response of amoxicillin from the Sample solution |
| rS | = | = peak response of amoxicillin from the Standard solution |
| CS | = | = concentration of USP Amoxicillin RS in the Standard solution (mg/mL) |
| CU | = | = 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 C8H9NO5 in the Amoxicillin and Clavulanate Potassium for Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × P × 100
| rU | = | = peak response of clavulanic acid from the Sample solution |
| rS | = | = peak response of clavulanic acid from the Standard solution |
| CS | = | = concentration of USP Clavulanate Lithium RS in the Standard solution (mg/mL) |
| CU | = | = 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 C16H19N3O5S and 90.0%–125.0% of the labeled amount of C8H9NO5
PERFORMANCE TESTS
• Deliverable Volume 
698
698
For powder packaged in multiple-unit containers:
Meets the requirements
• Uniformity of Dosage Units 905
905
For powder packaged in single-unit containers:
Meets the requirements
SPECIFIC TESTS
• pH 791:
3.8–6.6, in the suspension constituted as directed in the labeling, the test being performed immediately after constitution
791:
3.8–6.6, 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.
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.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers, at controlled room temperature.
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 |
| 61 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 62 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2199
Pharmacopeial Forum: Volume No. 36(4) Page 899