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 D is a critical reference standard for pharmaceutical quality control, defined by the European Pharmacopoeia. This degradation product arises during <strong>synthesis</strong> or storage of Cefepime hydrochloride. Its molecular formula is <strong>C19H24N6O5S2</strong> with CAS number <strong>112780-06-4</strong>, serving as an essential tool for identifying trace impurities in bulk API batches.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used to validate HPLC methods for detecting related substances in finished injectable formulations.</li>
<li><strong>R&D:</strong> Employed in stability-indicating studies to monitor degradation pathways under various 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>Strictly store in sealed containers at <strong>-20°C</strong> away from light and moisture. Handle with appropriate PPE in a fume hood to avoid inhalation risks. Not intended for direct clinical administration; use exclusively for analytical validation purposes.</p>