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 A is a critical reference standard defined by the European Pharmacopoeia for quality control of the cephalosporin antibiotic Cefamandole. It serves as an identity and purity marker in pharmaceutical manufacturing processes involving <strong>HPLC</strong> analysis. The compound features the molecular formula <strong>C16H17N5O4S2</strong> and carries CAS registry number <strong>68907-09-3</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Assurance:</strong> Used to validate analytical methods and establish acceptance limits in bulk drug substance testing.</li>
<li><strong>R&D:</strong> Employed in stability-indicating studies to monitor degradation pathways during formulation development.</li>
<li><strong>Regulatory Compliance:</strong> Essential for generating impurity profiles required for IND and NDA submissions to global health authorities.</li>
</ul>
<h3>Precautions</h3>
<p>Storage requires sealed containers at controlled temperatures between 2°C and 8°C to prevent hydrolysis. Handling must be performed with appropriate PPE due to potential sensitization risks. This material is strictly for laboratory research and not intended for direct clinical administration or therapeutic use.</p>