Lysine Acetylsalicylate Impurity 8;Lysine, N2-(2-hydroxybenzoyl)-;Lysine Acetylsalicylate Impurity H
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<h3>Overview</h3>
<p>Lysine Acetylsalicylate Impurity H is a critical synthetic byproduct in the manufacturing of <strong>lysine acetylsalicylate</strong>. Its molecular formula is <strong>C<sub>14</sub>H<sub>20</sub>N<sub>2</sub>O<sub>5</sub></strong> (CAS No. 1069-56-7). This impurity typically arises during esterification or salt formation processes involving acetylsalicylic acid and lysine.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Serves as a reference standard for HPLC analysis to ensure pharmaceutical purity.</li>
<li><strong>R&D:</strong> Used in stability studies to monitor degradation pathways of aspirin derivatives.</li>
<li><strong>Regulatory Compliance:</strong> Essential for validating batch release specifications under ICH guidelines.</li>
</ul>
<h3>Precautions</h3>
<ul>
<li><strong>Safety:</strong> Handle with gloves; avoid inhalation of dust particles.</li>
<li><strong>Storage:</strong> Store in a cool, dry place away from direct sunlight at controlled room temperature.</li>
<li><strong>Usage:</strong> Strictly for research purposes only; not intended for human or animal clinical administration.</li>
</ul>