*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p><strong>Bromhexine EP Impurity C</strong> is a degradation product of the mucolytic agent bromhexine hydrochloride, typically formed via oxidative pathways during synthesis or storage. It serves as a critical reference standard for pharmaceutical quality control under European Pharmacopoeia guidelines. The molecular formula is <strong>C14H20BrNO2</strong> and its CAS number is <strong>6935-08-4</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Assurance:</strong> Used in HPLC method validation to identify and quantify trace impurities in active pharmaceutical ingredients.</li>
<li><strong>R&D:</strong> Employed in stability studies to monitor degradation kinetics and establish shelf-life limits.</li>
<li><strong>Regulatory Compliance:</strong> Required for dossier submissions to demonstrate adherence to ICH Q3A impurity thresholds.</li>
</ul>
<h3>Precautions</h3>
<p>Store at controlled room temperature (15-25°C) in tightly sealed containers away from light and moisture. Handle with appropriate PPE including gloves and eye protection to prevent skin contact. This material is strictly for laboratory research and analytical use only; it is not intended for human clinical administration.</p>