*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Azelastine Impurity A is a critical reference standard for pharmaceutical quality control. It serves as an analytical benchmark to identify and quantify degradation products in Azelastine hydrochloride formulations. The compound is synthesized via specific organic pathways involving the condensation of appropriate precursors under controlled conditions. Its molecular formula is <strong>C21H26ClN3O2</strong>, with CAS number <strong>140587-76-2</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Pharmaceutical R&D:</strong> Used in method development and validation for HPLC analysis.</li>
<li><strong>Quality Assurance:</strong> Serves as a calibration standard for impurity profiling during stability testing.</li>
<li><strong>Regulatory Compliance:</strong> Essential for generating data required by FDA and EMA guidelines on drug substance purity.</li>
</ul>
<h3>Precautions</h3>
<p>This material is intended solely for research and laboratory use, not for human administration. Storage requires sealed containers at temperatures between 2°C and 8°C, protected from light and moisture to maintain chemical integrity and prevent degradation.</p>