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>Cefamandole EP Impurity C Sodium Salt is a critical reference standard for pharmaceutical quality control, specifically monitoring degradation pathways during the <strong>sodium salt synthesis</strong> of cephalosporin antibiotics. Its molecular formula is <strong>C16H15N4NaO7S2</strong> (CAS: 89730-22-7), serving as an essential marker for identifying specific oxidative byproducts in bulk drug substances.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Assurance:</strong> Utilized in HPLC method validation to detect and quantify trace impurities in Cefamandole formulations.</li>
<li><strong>R&D:</strong> Supports stability-indicating studies to map degradation kinetics under various stress conditions.</li>
<li><strong>Regulatory Compliance:</strong> Required for filing dossiers with EMA and FDA to demonstrate purity levels within ICH guidelines.</li>
</ul>
<h3>Precautions</h3>
<p>Strictly store in a cool, dry place below 25°C away from direct sunlight. Personnel must wear appropriate PPE including gloves and masks to prevent inhalation or skin contact, as high concentrations may pose sensitization risks.</p>