*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Guaifenesin EP Impurity D is a specified degradation product of the expectorant active pharmaceutical ingredient, monitored to ensure compliance with European Pharmacopoeia standards. Synthesized via controlled oxidation or hydrolysis pathways during manufacturing, its molecular formula is <strong>C<sub>10</sub>H<sub>12</sub>O<sub>5</sub></strong> and CAS number is <strong>6487-97-0</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Serves as a reference standard for HPLC method validation in API production.</li>
<li><strong>R&D:</strong> Used in forced degradation studies to assess stability-indicating capabilities.</li>
<li><strong>Regulatory Compliance:</strong> Essential for generating impurity profiles required by EMA filings.</li>
</ul>
<h3>Precautions</h3>
<p>Strictly store under inert atmosphere at 2-8°C away from light. Handle only in certified fume hoods using appropriate PPE due to potential irritancy. Do not use for clinical administration; intended solely for analytical laboratory purposes.</p>