Cefuroxime Axetil for Oral Suspension
DEFINITION
Cefuroxime Axetil for Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of cefuroxime (C16H16N4O8S).
IDENTIFICATION
• The retention times of the major peaks for cefuroxime axetil diastereoisomers A and B of the Sample solution correspond to those of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Buffer:
23 mg/mL of monobasic ammonium phosphate in water
Mobile phase:
Methanol and Solution A (19:31)
System suitability stock solution A:
1.2 mg/mL of USP Cefuroxime Axetil RS in methanol
System suitability stock solution B:
0.16 mg/mL of USP Cefuroxime Axetil Delta-3 Isomers RS in methanol
System suitability solution:
Transfer 10.0 mL of System suitability stock solution A to a 50-mL volumetric flask. Add 5.0 mL of methanol and 3.8 mL of System suitability stock solution B. Dilute with Buffer to volume.
Standard stock solution:
1.2 mg/mL of USP Cefuroxime Axetil RS in methanol. [Note—Use this solution promptly. ]
Standard solution:
Transfer 10.0 mL of Standard stock solution to a 50-mL volumetric flask, add 8.8 mL of methanol, and dilute with Buffer to volume. [Note—Use this Standard solution promptly, or refrigerate and use on the day prepared. ]
Sample stock solution:
Equivalent to 2.5 mg/mL of cefuroxime, from constituted Oral Suspension, in methanol. Pass through a suitable filter. [Note—Constitute as directed on the label. To a suitable aliquot, freshly prepared and free of bubbles, add a suitable volume of methanol, shake by mechanical means for 10 min, dilute to volume with methanol, and mix. ]
Sample solution:
Transfer 5.0 mL of the filtered Sample stock solution to a 50-mL volumetric flask. Add 13.8 mL of methanol, and dilute with Buffer to volume. [Note—Protect the Sample solution from light and use promptly, or refrigerate and use on the day prepared. ]
Chromatographic system
Mode:
LC
Detector:
UV 278 nm
Column:
4.6-mm × 25-cm; 5-µm packing L13
Flow rate:
1.5 mL/min
Injection size:
10 µL
System suitability
Samples:
System suitability solution and Standard solution
[Note—The relative retention times for acetanilide, cefuroxime axetil diastereoisomer B, cefuroxime axetil diastereoisomer A, and cefuroxime axetil delta-3 isomers are 0.4, 0.8, 0.9, and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 1.5 between cefuroxime axetil diastereoisomer A and B; NLT 1.5 between cefuroxime axetil diastereoisomer A and cefuroxime axetil delta-3 isomers, System suitability solution
Column efficiency:
NLT 3000 theoretical plates when measured using the cefuroxime axetil diastereoisomer A peak, Standard solution
Relative standard deviation:
NMT 2.0%, Standard solution
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C16H16N4O8S in the Cefuroxime Axetil for Oral Suspension taken:
Result = (RU/RS) × (CS/CU) × P × F × [1 
(K/100)] × 100
(K/100)] × 100| RU | = | = sum of the peak responses of cefuroxime axetil diastereoisomers A and B from the Sample solution |
| RS | = | = sum of the peak responses of cefuroxime axetil diastereoisomers A and B from the Standard solution |
| CS | = | = concentration of the Standard solution (mg/mL) |
| CU | = | = nominal concentration of cefuroxime axetil in the Sample solution (mg/mL) |
| P | = | = potency of cefuroxime in anhydrous USP Cefuroxime Axetil RS (µg/mg) |
| F | = | = unit conversion factor, 0.001 mg/µg |
| K | = | = water content of USP Cefuroxime Axetil RS (%) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 
711
711
Medium:
0.07 M of pH 7.0 phosphate buffer (dissolve 3.7 mg/mL of monobasic sodium phosphate and 5.7mg/mL of anhydrous dibasic sodium phosphate in water); 900 mL
Apparatus 2:
50 rpm
Time:
30 min
Analysis:
Test 5.0 mL of constituted Cefuroxime Axetil for Oral Suspension equivalent to 125 or 250 mg of cefuroxime. Determine the amount of cefuroxime equivalent dissolved by using UV absorption at the wavelength of maximum absorbance at 280 nm on filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Cefuroxime Axetil RS in the same Medium.
Tolerances:
NLT 60% (Q) of the labeled amount of C16H16N4O8S is dissolved.
• Uniformity of Dosage Units 905
905
For solid packaged in single-unit containers:
Constitute Cefuroxime Axetil for Oral Suspension as directed in the labeling. Mix, and allow the container to drain into a beaker for 5 s. Withdraw and assay 5.0 mL of the Oral Suspension from the beaker, or the total amount if it is less than 5 mL. It meets the requirements.
• Deliverable Volume 698
698
For solid packaged in multiple-unit containers:
Constitute Cefuroxime Axetil for Oral Suspension as directed in the labeling. It meets the requirements.
SPECIFIC TESTS
• pH 791:
3.5–7.0, in the solution constituted as directed in the labeling
791:
3.5–7.0, in the solution constituted as directed in the labeling
• Water Determination, Method I 921:
NMT 6.0%
921:
NMT 6.0%
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers, and store at controlled room temperature.
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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 2579
Pharmacopeial Forum: Volume No. 35(5) Page 1123