Cefuroxime Sulfoxide

Product Code:C022019
English Name:Cefuroxime Impurity 19
English Alias:(E)-2-(furan-2-yl)-2-(methoxyimino)acetic acid
CAS No.:69384-96-9
Molecular Formula:C₇H₇NO₄
Molecular Weight:169.13
High-Purity Reference Standard:Confirmed by HPLC (≥99.0%), NMR (1H, 13C), and HRMS, suitable for precise analysis of Cefuroxime impurities.
Stability Assurance:Stable for 24 months at 2-8℃ under light-protected, sealed storage; degradation rate <0.3% in methanol solution within 1 month.
Quality Control Testing:Used for HPLC and LC-MS detection of Impurity 19 in Cefuroxime API and formulations, controlling impurity content to meet ICH Q3A standards (≤0.1%).
Process Optimization Research:Monitors impurity formation during Cefuroxime synthesis, reducing generation by >50% by adjusting methoxyimination temperature (e.g., 10-15℃) and reaction time.
Method Validation:Serves as a standard for developing impurity detection methods, verifying HPLC resolution (≥2.0) and LOD (0.01 ng/mL).
Cefuroxime, a second-generation cephalosporin antibiotic, is used to treat various bacterial infections. Impurity 19 may originate from side reactions during the synthesis of Cefuroxime's side chain. The furan ring and methoxyimino group in its structure may affect drug stability and antibacterial activity. With stricter WHO requirements for antibiotic impurity control, studying such process impurities is key to ensuring drug quality.
Detection Technology:UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 1.8 minutes, with LOD of 0.002 ng/mL for trace analysis.
Formation Mechanism:Formed by reaction of furanacetic acid with methoxyamine under alkaline conditions (e.g., sodium carbonate catalysis); optimizing reaction pH (8.0-9.0) and reagent ratio inhibits side reactions.
Safety Evaluation:In vitro antibacterial assays show MIC >64 μg/mL against Staphylococcus aureus (Cefuroxime MIC=0.5 μg/mL), with low toxicity but requiring ≤0.1% limit. Long-term stability testing is ongoing for degradation monitoring.
This product is intended for laboratory use only!
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