Cefuroxime Axetil for Oral Suspension

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION 

Cefuroxime Axetil for Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of cefuroxime (C₁₆H₁₆N₄O₈S).  

2 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. 

3 ASSAY 

Change to read: 

Procedure 

Solution A: 23 g/L 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 Solution A 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 Solution A 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 Solution A to volume. [Note—Protect the Sample solution from light and use promptly, or refrigerate and use on the day prepared. ] Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

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 cefuroxime axetil diastereoisomer B, cefuroxime axetil diastereoisomer A, and cefuroxime axetil delta-3 isomers are 0.8, 0.9, and 1.0, (ERR 1-Jun-2024) 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 = (R_U/R_S) × (C_S/C_U) × P × F × [1 − (K/100)] × 100 

R_U = sum of the peak responses of cefuroxime axetil diastereoisomers A and B from the Sample solution 

R_S = sum of the peak responses of cefuroxime axetil diastereoisomers A and B from the Standard solution 

C_S = concentration of the Standard solution (mg/mL) 

C_U = 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% 

4 PERFORMANCE TESTS 

Dissolution 〈711〉 

Medium: 0.07 M of pH 7.0 phosphate buffer (dissolve 3.7 mg/mL of monobasic sodium phosphate and 5.7 mg/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〉: Meets the requirements 

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. 

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. 

5 SPECIFIC TESTS 

pH 〈791〉: 3.5–7.0, in the solution constituted as directed in the labeling 

Water Determination, Method I〈921〉: NMT 6.0% 

6 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in well-closed containers, and store at controlled room temperature. 

USP Reference Standards 〈11〉 

USP Cefuroxime Axetil RS 

USP Cefuroxime Axetil Delta-3-Isomers RS