*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Azelastine Impurity D (USP) is a specified degradation product of the antihistamine Azelastine. It serves as a critical reference standard for quality control in pharmaceutical manufacturing to ensure compliance with USP monographs. The compound is typically identified via <strong>molecular formula C21H25ClN4O2</strong> and <strong>CAS No. 117608-93-2</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Pharmaceutical Analysis:</strong> Used in HPLC method validation to detect and quantify impurities in active pharmaceutical ingredients.</li>
<li><strong>Quality Assurance:</strong> Essential for stability testing to monitor degradation pathways during storage and shelf-life determination.</li>
<li><strong>R&D Support:</strong> Assists in structural elucidation and impurity profiling during drug development processes.</li>
</ul>
<h3>Precautions</h3>
<ul>
<li><strong>Storage:</strong> Maintain at controlled room temperature, protected from light and moisture.</li>
<li><strong>Safety:</strong> Handle with appropriate PPE; avoid inhalation or skin contact due to potential irritancy.</li>
<li><strong>Usage:</strong> Strictly for research and analytical purposes only; not intended for human or veterinary clinical use.</li>
</ul>