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>Cefixime Impurity 1 is a critical degradation product of the cephalosporin antibiotic Cefixime. Its <strong>molecular formula</strong> is C<sub>16</sub>H<sub>17</sub>N<sub>5</sub>O<sub>8</sub>S<sub>2</sub>, with <strong>CAS No.</strong> 109470-35-5. Synthesized via specific acylation routes during API manufacturing, it serves as a vital reference standard for purity assessment and stability testing in pharmaceutical quality control.</p>
<h3>Application</h3>
<ul>
<li><strong>Pharmaceutical QC:</strong> Used as an analytical standard to validate HPLC methods for detecting trace impurities in finished drug products.</li>
<li><strong>R&D Studies:</strong> Employed in stress testing to understand degradation pathways and establish shelf-life limits for formulations.</li>
<li><strong>Regulatory Compliance:</strong> Essential for submitting impurity profiles to FDA and EMA to ensure adherence to ICH Q3A guidelines.</li>
</ul>
<h3>Precautions</h3>
<p>Store in a cool, dry place below 25°C under inert atmosphere to prevent hydrolysis. Handle with appropriate PPE to avoid skin contact or inhalation. This substance is strictly for research use only and not approved for direct clinical administration.</p>