*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Mesalazine EP Impurity C is a critical reference standard for the pharmaceutical industry, utilized to validate the purity of 5-aminosalicylic acid formulations. Synthesized via controlled nitration and reduction processes, this compound serves as an essential marker in quality control protocols. Its chemical identity is defined by the molecular formula <strong>C<sub>7</sub>H<sub>7</sub>NO<sub>3</sub></strong> and CAS number <strong>619-80-5</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used as a calibration standard in HPLC analysis to detect trace impurities in Mesalazine bulk drugs.</li>
<li><strong>R&D:</strong> Employed in stability-indicating method development to monitor degradation pathways during storage.</li>
<li><strong>Regulatory Compliance:</strong> Essential for generating toxicological data required by EMA and FDA submissions for generic drug approval.</li>
</ul>
<h3>Precautions</h3>
<p>Strictly store in a cool, dry place under inert atmosphere to prevent oxidation. Personnel must utilize appropriate PPE including nitrile gloves and safety goggles due to potential skin irritation. This substance is for research use only and not intended for direct clinical administration.</p>