*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Capecitabine Impurity D is a critical reference standard for the quality control of the anticancer drug Capecitabine. It serves as an essential tool in pharmaceutical manufacturing to ensure product purity and safety compliance. The compound acts as a degradation product or synthetic intermediate, requiring precise characterization during process validation.</p>
<strong>Molecular Formula:</strong> C15H22N4O4<br>
<strong>CAS No:</strong> 168065-79-6
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used as an analytical standard to identify and quantify impurities in final drug substances.</li>
<li><strong>R&D:</strong> Supports stability studies to monitor degradation pathways under various stress conditions.</li>
<li><strong>Regulatory Compliance:</strong> Provides data necessary for FDA and EMA filings regarding impurity profiles.</li>
</ul>
<h3>Precautions</h3>
<ul>
<li><strong>Storage:</strong> Maintain at -20°C in a dry, inert atmosphere to prevent hydrolysis.</li>
<li><strong>Safety:</strong> Handle with appropriate PPE; classified as a potential mutagen requiring strict containment.</li>
<li><strong>Usage:</strong> For research use only; not intended for direct clinical administration to patients.</li>
</ul>