*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p><strong>Methotrexate EP Impurity C</strong> is a critical reference standard defined by the European Pharmacopoeia. It serves as an analytical marker for quality control in methotrexate synthesis, typically arising from side reactions during the condensation of 2,4-diamino-6-hydroxypyrimidine with phthalic anhydride derivatives. Its molecular formula is <strong>C19H15N7O4</strong> and CAS number is <strong>1084-34-8</strong>.</p>
<h3>Application</h3>
<ul>
<li>Pharmaceutical R&D: Validation of synthetic pathways and process optimization.</li>
<li>Quality Assurance: Identification and quantification of impurities in bulk API testing.</li>
<li>Regulatory Compliance: Supporting registration dossiers for ICH Q3A/B guidelines.</li>
</ul>
<h3>Precautions</h3>
<p>Strictly store under inert atmosphere at 2-8°C to prevent degradation. Handle with appropriate PPE due to potential cytotoxicity; avoid inhalation or skin contact during laboratory weighing and preparation.</p>