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 B is a critical degradation product and synthetic intermediate of the fourth-generation cephalosporin antibiotic. Its molecular structure defines specific impurity profiles in pharmaceutical manufacturing, essential for quality control compliance. <strong>Molecular Formula</strong>: C<sub>19</sub>H<sub>24</sub>N<sub>6</sub>O<sub>5</sub>S<sub>2</sub>; <strong>CAS No.</strong>: 107438-63-9.</p>
<h3>Application</h3>
<ul>
<li><strong>Pharmaceutical R&D</strong>: Used as reference standards for method validation and stability testing in drug substance analysis.</li>
<li><strong>Quality Assurance</strong>: Serves as an analytical standard to quantify trace impurities in Cefepime bulk drugs per ICH guidelines.</li>
<li><strong>Regulatory Compliance</strong>: Supports submission dossiers for FDA and EMA by ensuring accurate identification of process-related impurities.</li>
</ul>
<h3>Precautions</h3>
<p>Strictly store under inert atmosphere at 2-8°C to prevent hydrolysis. Handle with appropriate PPE to avoid skin contact; dust inhalation may cause respiratory sensitization. Not intended for direct clinical use or therapeutic administration.</p>