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
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
SPECIFIC TESTS
•  pH 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.
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in tight containers, at controlled room temperature.
•  USP Reference Standards 11
USP Amoxicillin RS
USP Clavulanate Lithium RS
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