*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Roxithromycin Impurity H is a critical reference standard used in the pharmaceutical industry for quality control of the macrolide antibiotic Roxithromycin. It serves as an essential marker during synthesis and stability testing to ensure drug purity. The molecular formula is <strong>C21H37NO9</strong>, and its CAS number is <strong>140138-16-7</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Assurance:</strong> Utilized by API manufacturers to validate production batches against pharmacopeial standards.</li>
<li><strong>R&D Analysis:</strong> Applied in method development for HPLC and LC-MS to detect trace degradation products.</li>
<li><strong>Regulatory Compliance:</strong> Required for dossier submissions to agencies like FDA and EMA to demonstrate impurity profiling.</li>
</ul>
<h3>Precautions</h3>
<p>Store strictly at 2-8°C in a dry, light-resistant environment to prevent hydrolysis. Personnel must wear appropriate PPE including gloves and goggles during handling to avoid skin contact or inhalation of dust particles.</p>