*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Rosuvastatin EP Impurity D is a <strong>pharmaceutical reference standard</strong> utilized for quality control in statin manufacturing. Synthesized via specific <strong>oxidation pathways</strong>, it serves as an impurity marker under European Pharmacopoeia guidelines. Its molecular formula is C<sub>22</sub>H<sub>28</sub>N<sub>2</sub>O<sub>5</sub>S, and CAS No. 146047-93-0.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Assurance:</strong> Validating purity levels during Rosuvastatin API production.</li>
<li><strong>Method Development:</strong> Calibrating HPLC systems for impurity profiling.</li>
<li><strong>Regulatory Compliance:</strong> Supporting stability testing dossiers for FDA and EMA submissions.</li>
</ul>
<h3>Precautions</h3>
<p>Store at <strong>-20°C</strong> in airtight containers to prevent degradation. Handle with appropriate PPE due to potential skin irritation; avoid direct contact in clinical settings.</p>