*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Tofacitinib Impurity 18 is a synthetic byproduct of <strong>Tofacitinib</strong> manufacturing, utilized for analytical method validation. Its molecular formula is <strong>C<sub>20</sub>H<sub>25</sub>N<sub>7</sub>O<sub>2</sub></strong> (CAS No. <strong>214699-26-6</strong>), typically derived via specific coupling reactions during the active pharmaceutical ingredient synthesis.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Serving as reference standards for HPLC and LC-MS impurity profiling in Tofacitinib batches.</li>
<li><strong>R&D:</strong> Supporting stability-indicating method development to ensure drug safety and regulatory compliance.</li>
<li><strong>Regulatory Filing:</strong> Providing data for ICH Q3A/B guidelines regarding residual organic impurities.</li>
</ul>
<h3>Precautions</h3>
<ul>
<li><strong>Storage:</strong> Maintain at -20°C in airtight, light-resistant containers to prevent degradation.</li>
<li><strong>Safety:</strong> Handle with appropriate PPE; avoid inhalation or skin contact due to potential irritancy.</li>
<li><strong>Usage:</strong> Strictly for research purposes only; not intended for human clinical administration.</li>
</ul>