*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Guaifenesin EP Impurity C is a specified degradation product of the expectorant Guaifenesin, monitored under European Pharmacopoeia standards. It typically arises from synthetic side reactions or oxidative pathways during manufacturing. <strong>Molecular Formula</strong>: C<sub>10</sub>H<sub>14</sub>O<sub>5</sub>; <strong>CAS No.</strong>: 2697-85-4. This reference standard ensures drug purity and regulatory compliance.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used as analytical reference in HPLC method validation for pharmaceutical manufacturers.</li>
<li><strong>R&D:</strong> Employed in stability-indicating studies to identify degradation profiles under stress conditions.</li>
<li><strong>Regulatory Compliance:</strong> Essential for generating impurity profiles required by FDA and EMA submissions.</li>
</ul>
<h3>Precautions</h3>
<p>Store strictly below 25°C in a dry, dark environment to prevent hydrolysis. Handle with appropriate PPE including gloves and eye protection. Not intended for clinical use; restricted to laboratory and industrial quality assurance contexts only.</p>