*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Ketorolac EP Impurity C is a critical reference standard used in pharmaceutical quality control to ensure the purity of Ketorolac Tromethamine. It represents a specific degradation product or synthetic byproduct defined under the European Pharmacopoeia guidelines. The compound serves as an essential benchmark for HPLC method validation and impurity profiling.</p>
<ul>
<li><strong>Molecular Formula:</strong> C15H19NO4</li>
<li><strong>CAS Number:</strong> 72603-89-3</li>
</ul>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used as a calibration standard for detecting trace levels in raw materials and finished dosage forms.</li>
<li><strong>R&D:</strong> Supports stability-indicating method development during drug formulation studies.</li>
<li><strong>Regulatory Compliance:</strong> Essential for generating data required by FDA and EMA submissions regarding impurity thresholds.</li>
</ul>
<h3>Precautions</h3>
<p>Store strictly at -20°C in a dry, dark environment to prevent hydrolysis or oxidation. Handle only with appropriate PPE in a fume hood due to potential skin irritation. This substance is for research use only and not intended for clinical administration.</p>