Clarithromycin Tablets
DEFINITION
Clarithromycin Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of C38H69NO13.
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
Mobile phase:
Methanol and 0.067 M monobasic potassium phosphate (13:7). Adjust with phosphoric acid to a pH of 4.0, and pass through a suitable filter.
Standard stock solution:
625 µg/mL of clarithromycin from USP Clarithromycin RS dissolved in methanol.
[Note—Shake and sonicate to facilitate dissolution. ]
Standard solution:
125 µg/mL of clarithromycin from Standard stock solution in Mobile phase. Pass through a suitable filter.
System suitability stock solution:
625 µg/mL of USP Clarithromycin Related Compound A RS in methanol.
System suitability solution:
125 µg/mL of USP Clarithromycin RS from Standard stock solution and 125 µg/mL of USP Clarithromycin Related Compound A RS from System suitability stock solution in Mobile phase
Sample stock solution:
Equivalent to 4 mg/mL of clarithromycin from finely powdered Tablets in methanol. [Note—Shake by mechanical means for 30 min to disperse and allow any insoluble matter to settle. ]
Sample solution:
120 µg/mL of clarithromycin from Sample stock solution in Mobile phase. Pass through a filter of 0.5-µm or finer pore size.
Chromatographic system
Mode:
LC
Detector:
UV 210 nm
Column:
4.6-mm × 15-cm; packing L1
[Note—A guard column containing packing L1 may be added. ]
Column temperature:
50
Flow rate:
1 mL/min
Injection size:
20–50 µL
System suitability
Samples:
System suitability solution and Standard solution
[Note—The relative retention times for clarithromycin and clarithromycin related compound A are 0.75 and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 2.0 between clarithromycin and clarithromycin related compound A, System suitability solution
Column efficiency:
NLT 750 theoretical plates from the clarithromycin peak, Standard solution
Tailing factor:
0.9–1.5, Standard solution
Relative standard deviation:
NMT 2.0%, Standard solution
Analysis
Samples:
Standard solution and Sample solution
Calculate percentage of label claim of C38H69NO13 in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of clarithromycin in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 
711
711
Buffer solution:
Prepare a solution containing 13.61 mg/mL of sodium acetate trihydrate in water. Prepare another solution by diluting 5.7 mL of glacial acetic acid to 1 L with water. Combine portions of the two solutions to obtain a pH of 5.0.
Medium:
Buffer solution, 900 mL
Apparatus 2:
50 rpm
Time:
30 min
Standard solution:
Proceed as directed in the Assay.
Sample solution:
Dilute with Mobile phase to yield a nominal concentration of 125 µg/mL of clarithromycin.
Mobile phase, System suitability solution, Chromatographic system, and System suitability:
Proceed as directed for Assay.
Analysis
Samples:
Standard solution and Sample solution
Determine the amount of C38H69NO13 dissolved in the Medium, as directed in the Assay.
Calculate the percentage of clarithromycin dissolved:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak area of the Sample solution |
| rS | = | = peak area of the Standard solution |
| CS | = | = concentration of the Standard solution (µg/mL) |
| CU | = | = nominal concentration of the Sample solution (µg/mL) |
Tolerances:
NLT 80% (Q) of the labeled amount of C38H69NO13 is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
SPECIFIC TESTS
• Loss on Drying 731:
Dry a portion of powdered Tablets in vacuum at a pressure not exceeding 5 mm of mercury at 110 for 3 h: it loses NMT 6.0% of its weight.
731:
Dry a portion of powdered Tablets in vacuum at a pressure not exceeding 5 mm of mercury at 110 for 3 h: it loses NMT 6.0% of its weight.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• USP Reference Standards 11
11
USP Clarithromycin RS 
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USP Clarithromycin Related Compound A RS
6,11-Di-O-methylerythromycin A.
C39H71NO13 762.00
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6,11-Di-O-methylerythromycin A.
C39H71NO13 762.00
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 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2692
Pharmacopeial Forum: Volume No. 35(5) Page 1124