*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p><strong>Levofloxacin Impurity 21</strong> is a critical reference standard used in the pharmaceutical manufacturing of levofloxacin, a broad-spectrum fluoroquinolone antibiotic. Synthesized via specific degradation pathways or side-reactions during the main process, its structure is defined by the molecular formula C<sub>18</sub>H<sub>20</sub>N<sub>2</sub>O<sub>5</sub> and CAS number <strong>164972-62-3</strong>. This compound serves as an essential tool for method development and validation.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used to identify and quantify trace impurities in bulk drug substances during stability testing.</li>
<li><strong>R&D:</strong> Applied in stress studies to validate the specificity of analytical methods like HPLC and LC-MS.</li>
<li><strong>Regulatory Compliance:</strong> Required for dossier submissions to agencies such as the FDA and EMA to ensure purity standards.</li>
</ul>
<h3>Precautions</h3>
<p>Store strictly at -20°C under inert atmosphere to prevent degradation. Handle with appropriate PPE including nitrile gloves and safety goggles due to potential irritant properties. Do not use in clinical settings; intended solely for laboratory research and quality analysis purposes.</p>