*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p><strong>(3S,5R)-Atorvastatin EP Impurity B Calcium Salt</strong> is a stereoisomeric reference standard used for the identification and quantification of specific degradation products in atorvastatin calcium. It features a defined chiral configuration essential for regulatory compliance testing. <strong>Molecular Formula: C33H34CaF2N2O10</strong>. <strong>CAS No.: 276893-75-9</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Pharmaceutical QC:</strong> Validated as an impurity standard for HPLC method validation under ICH guidelines.</li>
<li><strong>R&D:</strong> Supports stability-indicating studies to monitor drug substance degradation pathways.</li>
<li><strong>Regulatory Submissions:</strong> Provides critical data for IND and NDA filings regarding impurity profiling.</li>
</ul>
<h3>Precautions</h3>
<ul>
<li><strong>Storage:</strong> Maintain at -20°C in a desiccated environment to prevent hydrolysis.</li>
<li><strong>Safety:</strong> Handle with appropriate PPE; avoid inhalation or skin contact during weighing.</li>
<li><strong>Usage:</strong> Strictly for laboratory research and quality control analysis only, not for human administration.</li>
</ul>