*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Olaparib Impurity 11 is a synthetic reference standard for quality control of the PARP inhibitor Olaparib. It serves as a critical marker in process validation and stability testing to ensure pharmaceutical purity. The compound is characterized by its specific molecular structure defined as <strong>C20H24N4O3</strong> with CAS number <strong>2167895-74-1</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Assurance:</strong> Used in HPLC method development to identify and quantify trace impurities during drug manufacturing.</li>
<li><strong>Regulatory Compliance:</strong> Essential for generating documentation required by FDA and EMA guidelines regarding genotoxicity and safety thresholds.</li>
<li><strong>R&D Support:</strong> Facilitates degradation studies to determine shelf-life and storage conditions for finished formulations.</li>
</ul>
<h3>Precautions</h3>
<p>This substance is strictly for laboratory use only and must not be administered to humans. Store under inert atmosphere at -20°C to prevent hydrolysis. Personnel must utilize appropriate PPE, including nitrile gloves and safety goggles, when handling to avoid dermal absorption or inhalation risks.</p>