*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p><strong>Lansoprazole Impurity F (EP)</strong> is a specified degradation product of lansoprazole, primarily generated during synthesis or storage. It serves as a critical reference standard for quality control in pharmaceutical manufacturing to ensure compliance with European Pharmacopoeia limits. The molecular formula is C<sub>16</sub>H<sub>14</sub>N<sub>2</sub>O<sub>3</sub>S and the CAS number is 108057-92-7.</p>
<h3>Application</h3>
<ul>
<li>Pharmaceutical R&D: Used in method development and validation for impurity profiling.</li>
<li>Quality Control: Employed as a calibration standard for HPLC analysis in API production.</li>
<li>Regulatory Compliance: Essential for demonstrating purity levels in regulatory submissions (IND/NDA).</li>
</ul>
<h3>Precautions</h3>
<ul>
<li>Store in a cool, dry place away from direct sunlight and moisture.</li>
<li>Handle with appropriate PPE to avoid skin contact and inhalation of dust.</li>
<li>Not intended for clinical use; strictly for analytical purposes only.</li>
</ul>