*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Capecitabine Impurity G (USP) is a critical reference standard for pharmaceutical quality control, specifically defined as <strong>4-amino-5-(2-deoxy-2-fluoro-beta-D-ribofuranosyl)-1H-pyrimidine-2-carboxamide</strong>. This compound serves as an essential marker in the synthesis and stability testing of the anticancer prodrug Capecitabine. Its molecular formula is <strong>C10H16FN3O4</strong>, with CAS Registry Number <strong>170988-55-1</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Assurance:</strong> Utilized in HPLC method validation to detect trace levels during drug manufacturing.</li>
<li><strong>Stability Testing:</strong> Monitored under ICH guidelines to assess degradation pathways in finished products.</li>
<li><strong>Regulatory Compliance:</strong> Sourced for filing applications with FDA and EMA to ensure impurity profiling accuracy.</li>
</ul>
<h3>Precautions</h3>
<p>Strictly store at <strong>-20°C</strong> in a desiccated environment to prevent hydrolysis. Handle with appropriate PPE as it is a biological active substance; avoid direct skin contact and inhalation of dust particles during weighing procedures.</p>