Product Description
Shenzhen Excellent Biomedical Technology Co.,Ltd.(SZEB) is a leading supplier of high quality pharmaceutical impurities,API related compounds,intermediates,labeled standards and impurity custom synthesis services.E-mail:sales@ex-biotech.com.
Discover all our products through our official website (https://www.ex-biotech.com/), and get in touch if you have any questions about how we can help support your work. Email:sale@ex-biotech.com.
AI Product Description
*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Cefixime Impurity B (E-isomer) is a critical reference standard representing the thermodynamic <strong>E-isomer</strong> formed during the synthesis of the third-generation cephalosporin antibiotic Cefixime. It arises from isomerization of the oxime moiety, necessitating strict control in pharmaceutical manufacturing. The compound features the molecular formula <strong>C16H15N5O7S2</strong> and is identified by CAS No. <strong>90648-89-4</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used as an analytical standard to quantify impurities in drug substances via HPLC.</li>
<li><strong>R&D Validation:</strong> Essential for method development and stability testing of generic Cefixime formulations.</li>
<li><strong>Regulatory Compliance:</strong> Supports FDA and EMA filings by defining acceptable limits for process-related impurities.</li>
</ul>
<h3>Precautions</h3>
<p>Store under inert atmosphere at 2°C–8°C to prevent degradation. Handle with appropriate PPE in well-ventilated areas; avoid direct skin contact. Strictly adhere to ICH Q3B guidelines regarding residual impurities in final drug products.</p>