*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Cetirizine EP Impurity G is a critical reference standard defined in the European Pharmacopoeia for quality control of antihistamine APIs. Synthesized via specific oxidative pathways during manufacturing, it serves to validate purity profiles. The molecular formula is <strong>C21H26ClNO4</strong> with CAS number <strong>108979-98-0</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Pharmaceutical QC:</strong> Used as analytical standards in HPLC methods for assay and impurity profiling.</li>
<li><strong>R&D:</strong> Supports stability studies and method validation for cetirizine hydrochloride production.</li>
<li><strong>Regulatory Compliance:</strong> Essential for meeting ICH Q3A guidelines during drug registration filings.</li>
</ul>
<h3>Precautions</h3>
<p>Store under inert atmosphere at -20°C to prevent degradation. Handle with appropriate PPE in ventilated areas to avoid inhalation risks. Not intended for clinical use or therapeutic administration.</p>