Printed on: Sat Jun 26 2021, 06:54:36 AM Official Status: Currently Official on 26-Jun-2021 DocId: 1_GUID-BF9F3A49-653F-45B1-A085-9FF00E84FC04_1_en-US

(EST)
Printed by: Nguyen Nhan Official Date: Official Prior to 2013 Document Type: USP @2021 USPC
1

rU = peak response of amoxicillin from the Sample

Amoxicillin and Clavulanate Potassium solution
for Oral Suspension rS = peak response of amoxicillin from the Standard
solution
DEFINITION CS = concentration of USP Amoxicillin RS in the
Amoxicillin and Clavulanate Potassium for Oral Suspension Standard solution (mg/mL)
contains the equivalent of NLT 90.0% and NMT 120.0% of CU = nominal concentration of amoxicillin in the
the labeled amount of amoxicillin (C16H19N3O5S) and the Sample solution (mg/mL)
equivalent of NLT 90.0% and NMT 125.0% of the labeled P = potency of amoxicillin in USP Amoxicillin RS
amount of clavulanic acid (C8H9NO5). It contains one or more (µg/mg)
suitable buffers, colors, flavors, preservatives, stabilizers, F = conversion factor, 0.001 mg/µg
sweeteners, and suspending agents.
Calculate the percentage of the labeled amount of
IDENTIFICATION clavulanic acid (C8H9NO5) in the Amoxicillin and
• A. The retention times of the major peaks of the Sample Clavulanate Potassium for Oral Suspension taken:
solution correspond to those of the Standard solution, as
obtained in the Assay. Result = (rU/rS) × (CS/CU) × P × 100
ASSAY
• PROCEDURE rU = peak response of clavulanic acid from the
Buffer: 7.8 g of monobasic sodium phosphate in 900 mL of Sample solution
water. Adjust with phosphoric acid or 10 N sodium rS = peak response of clavulanic acid from the
hydroxide to a pH of 4.4 ± 0.1, and dilute with water to Standard solution
CS = concentration of USP Clavulanate Lithium RS in

al
1000 mL.
Mobile phase: Methanol and Buffer (1:19). Pass through a the Standard solution (mg/mL)
suitable filter. CU = nominal concentration of clavulanic acid in the
Standard solution: 0.5 mg/mL of USP Amoxicillin RS and Sample solution (mg/mL)
0.2 mg/mL of USP Clavulanate Lithium RS in water P = potency of clavulanic acid in USP Clavulanate
Lithium RS (mg/mg)
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
ci Acceptance criteria: 90.0%–120.0% of the labeled amount
of amoxicillin (C16H19N3O5S) and 90.0%–125.0% of the
means for 10 min, and filter. Use within 1 h. labeled amount of clavulanic acid (C8H9NO5)
Chromatographic system
ffi
PERFORMANCE TESTS
(See Chromatography á621ñ, System Suitability.) • DELIVERABLE VOLUME á698ñ
Mode: LC For powder packaged in multiple-unit containers: Meets
Detector: UV 220 nm the requirements
Column: 4-mm × 30-cm; 3- to 10-µm packing L1 • UNIFORMITY OF DOSAGE UNITS á905ñ
Flow rate: 2 mL/min For powder packaged in single-unit containers: Meets the
Injection volume: 20 µL
O

requirements
System suitability
Sample: Standard solution SPECIFIC TESTS
[NOTE—The relative retention times for clavulanic acid • PH á791ñ
and amoxicillin are about 0.5 and 1.0, respectively.] Sample solution: Constitute as directed in the labeling, and
Suitability requirements perform the test immediately after constitution.
Resolution: NLT 3.5 between the amoxicillin and Acceptance criteria: 3.8–6.6
clavulanic acid peaks • MICROBIAL ENUMERATION TESTS á61ñ and TESTS FOR
Tailing factor: NMT 1.5 for each analyte peak SPECIFIED MICROORGANISMS á62ñ: The total aerobic
Relative standard deviation: NMT 2.0% for each microbial count does not exceed 103 cfu/g, and the total
analyte peak combined molds and yeasts count does not exceed 102 cfu/
Analysis g.
Samples: Standard solution and Sample solution ADDITIONAL REQUIREMENTS
Calculate the percentage of the labeled amount of • PACKAGING AND STORAGE: Preserve in tight containers, at
amoxicillin (C16H19N3O5S) in the Amoxicillin and controlled room temperature.
Clavulanate Potassium for Oral Suspension taken: • USP REFERENCE STANDARDS á11ñ
USP Amoxicillin RS
Result = (rU/rS) × (CS/CU) × P × F × 100 USP Clavulanate Lithium RS

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