*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p><strong>Fotagliptin Impurity 17</strong> is a synthetic reference standard for the dipeptidyl peptidase-4 inhibitor. It serves as a critical control material in pharmaceutical manufacturing to ensure drug purity and compliance with ICH guidelines. The molecular formula is <strong>C20H28N4O3</strong>, associated with CAS No. <strong>1469588-88-6</strong>.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used in HPLC methods to identify and quantify trace impurities in Fotagliptin APIs.</li>
<li><strong>R&D:</strong> Supports stability studies and degradation pathway analysis during drug development.</li>
<li><strong>Regulatory Compliance:</strong> Essential for dossier submissions to agencies like FDA and EMA to validate batch consistency.</li>
</ul>
<h3>Precautions</h3>
<p>Store in a cool, dry place protected from light below 25°C. Personnel must wear appropriate PPE including gloves and goggles to avoid direct contact. This substance is strictly for laboratory use and not for clinical administration or human consumption.</p>