*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Tacrolimus Impurity 36 is a critical synthetic reference standard used in pharmaceutical quality control. It serves as an essential marker for identifying degradation products during the manufacturing of tacrolimus immunosuppressants. The compound features a specific molecular structure defined by the <strong>molecular formula</strong> C<sub>44</sub>H<sub>75</sub>NO<sub>12</sub> and carries the <strong>CAS number</strong> 189038-47-9.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Assurance:</strong> Utilized in HPLC method development to validate purity specifications for drug substances.</li>
<li><strong>Regulatory Compliance:</strong> Required for stability-indicating studies under ICH guidelines to monitor impurity profiles.</li>
<li><strong>R&D Support:</strong> Employed in synthesis optimization to track side-reaction pathways during tacrolimus production.</li>
</ul>
<h3>Precautions</h3>
<p>This substance is strictly for research use only and must not be administered to patients. Store in a cool, dry place below -20°C protected from light to prevent degradation. Handle with appropriate PPE including nitrile gloves and safety goggles to avoid direct skin contact or inhalation.</p>