*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Ibuprofen Impurity C (EP) is a specified degradation product defined in the European Pharmacopoeia for quality control of <strong>ibuprofen</strong>. It typically arises from synthetic side reactions or oxidative stress during manufacturing. The chemical structure corresponds to <strong>4-isobutyl-2-(4-hydroxyphenyl)butan-2-one</strong>, with CAS No. <strong>51146-78-6</strong> and molecular formula <strong>C13H18O2</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Assurance:</strong> Used as reference standards to validate HPLC methods for impurity profiling.</li>
<li><strong>R&D:</strong> Employed in stability studies to identify degradation pathways under various stress conditions.</li>
<li><strong>Regulatory Compliance:</strong> Essential for meeting ICH Q3A/B guidelines regarding residual impurities in API batches.</li>
</ul>
<h3>Precautions</h3>
<p>Store in a cool, dry place away from light to prevent oxidation. Handle with appropriate PPE including gloves and goggles to avoid skin contact. Not intended for clinical use; strictly limited to analytical and research applications within controlled laboratory environments.</p>