Product Name: Impurity of Paricalcitol from API broken down by oxidation -2
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><strong>Paricalcitol Oxidation Impurity -2</strong> is a synthetic degradation product formed via oxidative pathways during API manufacturing. It serves as a critical reference standard for quantifying process-related impurities in pharmaceutical synthesis. The molecular formula is C<sub>27</sub>H<sub>40</sub>O<sub>3</sub>, and it lacks a unique CAS registry number, typically identified by its structural elucidation data.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used in HPLC method validation to establish specificity limits for drug substance batches.</li>
<li><strong>R&D:</strong> Employed in stress testing to map oxidation mechanisms and optimize stability protocols.</li>
<li><strong>Regulatory Compliance:</strong> Essential for ICH Q3B reporting to ensure patient safety within acceptable thresholds.</li>
</ul>
<h3>Precautions</h3>
<p>Store strictly under inert atmosphere at -20°C to prevent further degradation. Handle with appropriate PPE due to potential sensitization risks; not intended for direct clinical administration or therapeutic use.</p>
(All Rights Reserved)
