Product Name: Impurity of Paricalcitol from API broken down by oxidation -1
CAS No.:
Quality Standard: Enterprise standard, content NLT 95%
Main Application: Impurity of Paricalcitol API
*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Paricalcitol oxidation impurity is a critical degradation product formed via <strong>photo-oxidation</strong> or thermal stress during synthesis. It serves as an essential reference standard for validating the purity of active pharmaceutical ingredients (APIs). Molecular formula: C<sub>27</sub>H<sub>40</sub>O<sub>3</sub>; CAS No.: 195386-37-5.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used in HPLC method validation to detect trace oxidized byproducts in Paricalcitol bulk drugs.</li>
<li><strong>R&D Stability:</strong> Employed in forced degradation studies to assess formulation shelf-life under oxidative conditions.</li>
<li><strong>Regulatory Compliance:</strong> Required for ICH Q3B documentation to establish acceptable limits in drug substance specifications.</li>
</ul>
<h3>Precautions</h3>
<p>Store strictly at -20°C in amber vials under inert atmosphere to prevent further degradation. Handle with appropriate PPE due to potential mutagenicity; avoid direct skin contact and inhalation of dust particles.</p>
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