*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Budesonide EP Impurity D is a specified degradation product of the corticosteroid Budesonide, utilized primarily for <strong>quality control</strong> in pharmaceutical manufacturing. Its synthesis involves specific oxidative pathways during API production. The compound features the molecular formula <strong>C25H34O6</strong> and CAS number <strong>119287-62-0</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>R&D Laboratories:</strong> Used to validate analytical methods such as HPLC and LC-MS.</li>
<li><strong>Manufacturing:</strong> Serves as a reference standard for impurity profiling during batch release testing.</li>
<li><strong>Regulatory Compliance:</strong> Essential for meeting ICH Q3A guidelines on impurity thresholds.</li>
</ul>
<h3>Precautions</h3>
<p>Strictly store under <strong>-20°C</strong> in a dry, inert atmosphere to prevent degradation. Handle only within certified fume hoods using appropriate PPE due to potential hormonal activity. Do not use in clinical formulations; strictly for laboratory analysis only.</p>