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>Afatinib Impurity C is a critical reference standard for quality control in the synthesis of Afatinib, a tyrosine kinase inhibitor. It serves as an essential marker during process validation to ensure pharmaceutical purity. <strong>Molecular Formula</strong>: C20H18ClFN4O; <strong>CAS No.</strong>: 1395786-97-2.</p>
<h3>Application</h3>
<ul>
<li><strong>Pharmaceutical Manufacturing</strong>: Used as a comparative standard in HPLC analysis to detect and quantify trace impurities in drug substance batches.</li>
<li><strong>R&D Validation</strong>: Employed in method development to verify the specificity and sensitivity of analytical protocols for Afatinib production.</li>
<li><strong>Regulatory Compliance</strong>: Provides data support for regulatory filings (IND/NDA) regarding impurity profiling and safety assessments.</li>
</ul>
<h3>Precautions</h3>
<p>Store strictly under inert atmosphere at -20°C away from light. Personnel must wear appropriate PPE including nitrile gloves and safety goggles to prevent skin contact or inhalation of dust particles during handling.</p>