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>Cefepime Impurity 2 and Ceftizoxime Impurity 11 are critical reference standards used in pharmaceutical quality control. These compounds serve as <strong>synthetic intermediates</strong> or degradation products identified during the manufacturing of fourth-generation cephalosporins. Precise characterization via <strong>HPLC</strong> ensures compliance with ICH guidelines.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used as analytical standards to detect and quantify trace impurities in bulk drug substances.</li>
<li><strong>R&D:</strong> Essential for method development and stability studies to monitor degradation pathways.</li>
<li><strong>Regulatory Compliance:</strong> Required for dossier submissions to FDA and EMA to validate purity profiles.</li>
</ul>
<h3>Precautions</h3>
<p>Store materials at <strong>-20°C</strong> in airtight, light-resistant containers to prevent hydrolysis. Handle only within certified laboratories using appropriate PPE due to potential allergenic properties associated with beta-lactam structures. Do not use for clinical administration.</p>