Amoxicillin Capsules
DEFINITION
Amoxicillin Capsules contain the equivalent of NLT 90.0% and NMT 120.0% of the labeled amount of amoxicillin (C16H19N3O5S).
IDENTIFICATION
• The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Buffer:
Dissolve 6.8 g/L of monobasic potassium phosphate in water. Adjust with a 45% (w/w) solution of potassium hydroxide to a pH of 5.0 ± 0.1.
Mobile phase:
Acetonitrile and Buffer (1:24)
Standard solution:
1.2 mg/mL of USP Amoxicillin RS in Buffer. [Note—Use this solution within 6 h. ]
Sample solution:
Remove, as completely as possible, the contents of NLT 20 Capsules. Mix the combined contents, and transfer a quantity, equivalent to 200 mg of anhydrous amoxicillin, to a 200-mL volumetric flask. Add Buffer to volume. Sonicate if necessary to ensure complete dissolution. [Note—Use this solution within 6 h. ]
Chromatographic system
Mode:
LC
Detector:
UV 230 nm
Column:
4-mm × 25-cm;10-µm packing L1
Flow rate:
1.5 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 2.5
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C16H19N3O5S in the portion of Capsules taken:
Result = (rU/rS) × (CS/CU) × P × F × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response 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 |
Acceptance criteria:
90.0%–120.0%
PERFORMANCE TESTS
• Dissolution 
711
711
Test 1
Medium:
Water; 900 mL
Apparatus 1:
100 rpm, for Capsules containing 250 mg
Apparatus 2:
75 rpm, for Capsules containing 500 mg
Time:
60 min
Analytical wavelength:
UV 272 nm
Standard solution:
USP Amoxicillin RS in Medium
Sample solution:
Pass a portion of the solution under test through a suitable filter. Dilute with Medium, if necessary, to a concentration that is similar to that of the Standard solution.
Tolerances:
NLT 80% (Q) of the labeled amount of C16H19N3O5S is dissolved.
Test 2:
If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.
Medium:
Water; 900 mL
Apparatus 1:
100 rpm
Time:
90 min
Analytical wavelength:
UV 272 nm
Standard solution:
USP Amoxicillin RS in Medium
Sample solution:
Pass a portion of the solution under test through a suitable filter. Dilute with Medium, if necessary, to a concentration that is similar to that of the Standard solution.
Tolerances:
NLT 80% (Q) of the labeled amount of C16H19N3O5S is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
SPECIFIC TESTS
• Microbial Enumeration Tests 61 and Tests 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 1022 cfu/g.
61 and Tests 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 1022 cfu/g.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers, and store at controlled room temperature.
• Labeling:
When more than one Dissolution test is given, the labeling states the Dissolution test used only if Test 1 is not used.
• USP Reference Standards 11
11
USP Amoxicillin 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 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| 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 2198
Pharmacopeial Forum: Volume No. 36(4) Page 892