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 EP Impurity A DiHCl is a specified degradation product of the fourth-generation cephalosporin antibiotic Cefepime. Synthesized via specific hydrolytic pathways, it serves as a critical reference standard for pharmaceutical quality control. Its chemical identity is defined by the molecular formula <strong>C19H24N6O5S2·2HCl</strong> and CAS number <strong>207887-63-2</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Assurance:</strong> Utilized in HPLC method validation to detect trace impurities in bulk drug substances.</li>
<li><strong>R&D Analysis:</strong> Employed during stability studies to monitor degradation profiles under stress conditions.</li>
<li><strong>Regulatory Compliance:</strong> Required for filing dossiers with EMA and FDA to ensure adherence to ICH Q3A guidelines.</li>
</ul>
<h3>Precautions</h3>
<p>This compound must be stored in sealed containers at temperatures below -20°C to prevent hydrolysis. Personnel handling this material are required to wear appropriate PPE due to potential sensitization risks associated with beta-lactam structures. It is strictly for laboratory research use only and not intended for clinical administration.</p>