DapagliflozinHydroperoxideImpurity;Dapagliflozinperoxideimpurities;Genotoxicimpuritiesofdapagliflozin;DapaglifChemicalbooklozinImpurity22(hydroperoxyimpurity);DapagliflozinImpurityPOE(hydroperoxyimpurity);Dapagliflozinperoxideimpurit
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<h3>Overview</h3>
<p>Dapagliflozin peroxide impurity is a critical degradation product of the SGLT2 inhibitor Dapagliflozin, formed via oxidative stress during synthesis or storage. It serves as an essential reference standard for purity profiling in pharmaceutical manufacturing. <strong>Molecular Formula</strong>: C17H24ClNO6S (specific structure varies by oxidation site). <strong>CAS No.</strong>: Not publicly assigned as a distinct commercial entity due to its transient nature and classification as a process-related impurity.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used in HPLC/GC methods to validate assay limits within drug substance specifications.</li>
<li><strong>R&D Stability Testing:</strong> Monitored during forced degradation studies to assess formulation robustness against oxidation.</li>
<li><strong>Toxicological Assessment:</strong> Evaluated in genotoxicity studies to ensure compliance with ICH M7 guidelines for mutagenic impurities.</li>
</ul>
<h3>Precautions</h3>
<p>Strictly handle under inert atmosphere to prevent further oxidation. Store at -20°C in amber glass vials away from light and moisture. Personnel must utilize appropriate PPE including nitrile gloves and safety goggles to avoid dermal exposure during analytical preparation.</p>