LigliptinImpurityCD10925;LinagliptinImp.CD10925;LinagliptinN-AminocarbonylImpurity;Urea,N-[1-[7-(2-butyn-1-yl)-2,3,6,7-tetrahydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-2,6-dioxo-1H-Chemicalbookpurin-8-yl]-3-piperidinyl]-;LinagliptinImpurity106;8-[(3R)-3-Aminocarbonylamino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-1H-purine-2,6-dione
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<h3>Overview</h3>
<p><strong>Linagliptin Impurity 106</strong> is a synthetic reference standard used in pharmaceutical quality control. It serves as an identification and quantification tool during the manufacturing of Linagliptin APIs. The compound features specific molecular structures critical for purity assessment.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used in HPLC methods to detect and quantify trace impurities in drug substances.</li>
<li><strong>R&D:</strong> Supports stability-indicating method development and degradation studies.</li>
<li><strong>Regulatory Compliance:</strong> Essential for dossier submissions to FDA and EMA regarding impurity profiles.</li>
</ul>
<h3>Precautions</h3>
<p>Store at -20°C in a dry, inert atmosphere. Handle with appropriate PPE; avoid direct contact and inhalation. Strictly for research use only, not for human consumption or clinical administration.</p>