*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Tolterodine Impurity 13 is a critical degradation product and synthetic intermediate of the antispasmodic drug Tolterodine. Its <strong>molecular formula</strong> is C<sub>21</sub>H<sub>25</sub>NO<sub>4</sub>, with <strong>CAS No.</strong> 190768-93-3. This compound is primarily utilized in pharmaceutical manufacturing for method validation and stability testing to ensure drug purity compliance.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used as reference standard in HPLC assays to identify and quantify impurities.</li>
<li><strong>R&D:</strong> Employed in forced degradation studies to map metabolic pathways and degradation profiles.</li>
<li><strong>Regulatory Compliance:</strong> Supports ICH guidelines for establishing acceptable limits in finished dosage forms.</li>
</ul>
<h3>Precautions</h3>
<p>This substance must be stored at -20°C in a desiccated environment away from light. Handling requires PPE including nitrile gloves and safety goggles to prevent skin contact. It is not intended for human clinical use or therapeutic application.</p>