Cefuroxime Axetil for Oral Suspension
Cefuroxime Axetil for Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of cefuroxime (C16H16N4O8S).
• 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.
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. [NoteUse 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. [NoteUse 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. [NoteConstitute 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. [NoteProtect the Sample solution from light and use promptly, or refrigerate and use on the day prepared. ]
Detector: UV 278 nm
Column: 4.6-mm × 25-cm; 5-µm packing L13
Flow rate: 1.5 mL/min
Injection size: 10 µL
Samples: System suitability solution and Standard solution
[NoteThe 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. ]
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
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
Acceptance criteria: 90.0%110.0%
• Dissolution 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
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
For solid packaged in multiple-unit containers: Constitute Cefuroxime Axetil for Oral Suspension as directed in the labeling. It meets the requirements.
• pH 791: 3.57.0, in the solution constituted as directed in the labeling
• Water Determination, Method I 921: NMT 6.0%
• Packaging and Storage: Preserve in well-closed containers, and store at controlled room temperature.
• USP Reference Standards 11
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USP35NF30 Page 2579Pharmacopeial Forum: Volume No. 35(5) Page 1123