*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Loratadine EP Impurity B (USP RC C) is a critical degradation product used for <strong>analytical standardization</strong> of the antihistamine Loratadine. Synthesized via oxidative pathways during API manufacturing, it ensures compliance with ICH guidelines. Molecular Formula: <strong>C22H27ClN2O4</strong>; CAS No.: <strong>150698-62-9</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Identification and quantification in pharmaceutical batches.</li>
<li><strong>Stability Testing:</strong> Forced degradation studies to assess drug shelf-life.</li>
<li><strong>Method Validation:</strong> Calibration of HPLC systems for impurity profiling.</li>
</ul>
<h3>Precautions</h3>
<p>Store at <strong>-20°C</strong> in a dry, inert atmosphere to prevent hydrolysis. Handle with appropriate PPE; avoid inhalation or skin contact as high purity standards require strict containment protocols.</p>