α-(2-Oxopyrrolidino)valerophenone-d6(Major);RocuroniumbromideEPimpurityE;1-[17β-acetoxy-3α-hydroxy-2β-(pyrrolidin-1-yl)-5α-androstan-16β-yl]-1-(prop-2-enyl)pyrrolidinium;RocuChemicalbookroniuMBroMideIMpurity18(EPiMpurityE);RocuroniumimpurityE;RocuroniumBromideImpurity5(RocuroniumBromideEPImpurityE);1-((2S,3S,5S,8R,9S,10S,13S,14S,16S,17R);RocuroniumEPImpurityE
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<h3>Overview</h3>
<p>Rocuronium Bromide EP Impurity E is a critical reference standard for pharmaceutical quality control, specifically defined within the European Pharmacopoeia guidelines. It serves as an essential marker for identifying degradation products during the <strong>manufacturing process</strong> of neuromuscular blocking agents. The compound possesses the molecular formula <strong>C24H38BrN2O</strong> and is registered under CAS No. <strong>157596-40-8</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Assurance:</strong> Used in HPLC method validation to detect trace impurities in bulk drug substances.</li>
<li><strong>Stability Testing:</strong> Monitors product integrity under stress conditions like heat or light exposure.</li>
<li><strong>Regulatory Compliance:</strong> Supports data submission for FDA and EMA regulatory filings regarding purity profiles.</li>
</ul>
<h3>Precautions</h3>
<p>Strictly store in sealed containers at controlled temperatures below <strong>-20°C</strong> to prevent hydrolysis. Handling requires appropriate PPE due to potential allergenic properties; avoid direct contact with skin or inhalation of dust particles during weighing procedures.</p>