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Postion:Product Catalog >Cefixime Impurity
Cefixime Impurity
  • Cefixime Impurity
  • Cefixime Impurity
  • Cefixime Impurity
  • Cefixime Impurity
  • Cefixime Impurity

Cefixime Impurity NEW

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Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-05-27

Product Details

Product Name: Cefixime Impurity CAS No.: 33748-00-4
Min. Order: 10mg Purity: 99%+ HPLC
Supply Ability: 1000 Release date: 2025/05/27

Cefixime Impurity

Article illustration



  • Product Information

  • Product Code: C054024

  • English Name: Cefixime Impurity 24

  • English Alias: (6R,7R)-8-oxo-7-(2-phenylacetamido)-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

  • CAS No.:33748-00-4

  • Molecular Formula: C??H??N?O?S

  • Molecular Weight: 344.38

  • Advantages

  • High-Purity Reference Standard: As a reference standard for Cefixime Impurity 24, its structure is confirmed by NMR and MS with ≥98.5% purity (HPLC), suitable for impurity analysis and quality control of cephalosporin antibiotics.

  • Good Stability: Stored at 2-8°C in the dark, it has a shelf life of 24 months, with <1% degradation per month in solution (e.g., methanol), ensuring reliable detection results.

  • Applications

  • Antibiotic Impurity Detection: Used for HPLC/LC-MS detection of Impurity 24 in Cefixime API and formulations, controlling impurity content ≤0.2% (refer to ICH Q3A).

  • Process Optimization: In Cefixime synthesis, monitor the generation of this impurity during the acylation stage (e.g., generation increases 3-fold at temperatures >50°C), and reduce its content to below 0.1% by adjusting reaction pH (controlled at 7.0-7.5).

  • Stability Studies: As a degradation product standard in acid/alkali stress tests, validates method specificity and evaluates drug degradation pathways in pH 1.2/6.8 buffers.

  • Background Description

  • Cefixime, a third-generation cephalosporin antibiotic, is used to treat bacterial infections. Impurity 24 may arise from side chain introduction or cyclization by-products during its synthesis. This impurity's structure contains vinyl and phenylacetyl groups, potentially affecting drug antibacterial activity and safety. FDA guidelines for cephalosporin impurities require genotoxicity screening for such β-lactam impurities, driving the use of high-purity reference standards.
  • Research Status

  • Detection Technology: UPLC-MS/MS is used with a C18 column (1.7μm, 2.1×100mm) and 0.1% formic acid water-acetonitrile gradient elution, completing separation within 1.5 minutes with a detection limit of 0.01 ng/mL, 4 times more efficient than traditional HPLC.

  • Formation Mechanism: Mainly originates from isomerization side reactions of the vinyl side chain during the acylation of 7-aminocephalosporanic acid (7-ACA) with phenylacetyl chloride. Using triethylamine as a base reduces isomerization, decreasing impurity content from 0.6% to 0.03%.

  • Safety Evaluation: In vitro experiments show the impurity has an MIC of 8 μg/mL against E. coli (Cefixime API is 0.125 μg/mL), indicating significantly reduced antibacterial activity but potential allergenicity. EMA sets its permissible daily exposure (PDE) ≤5 μg.

  • WhatsAPP: +86 17320513646
    E-mail: anna@molcoo.com


    NOTE!

    We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
    This product is intended for laboratory use only!

    WhatsAPP: +86 17320513646
    E-mail: anna@molcoo.com


    NEW IN STOCK!

    The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery! 





Company Profile Introduction

1. Drug standards and drug impurity reference substances: provide more than 20,000 kinds of spot impurity reference substances, with sufficient supply and same-day delivery. We have a professional R&D team and comprehensive quality control testing to ensure product quality and reliability. 2. Customized synthesis of impurities and new molecules: Quickly respond to the customized needs of CDE impurities, stably supply impurities that have established quality standards, and provide customized synthesis services for new compounds in the research and development of innovative drugs. 3. Preparation and separation of unknown impurities: With a professional impurity preparation and separation technical team and SFC preparation and separation instruments, we can solve the problems of impurity preparation in complex projects. 4. Process development of new drug intermediates: provide the supply of new drugs and new molecular impurities, process optimization services, as well as the screening and impurity analysis of commercialization routes. 5. Peptide synthesis: Provide customized peptide synthesis services, and cover all kinds of degradation impurities and process impurities generated in the research and development of peptide drugs. At the same time, it provides comprehensive structural confirmation data and customized testing services.

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