Product Description
Shenzhen Excellent Biomedical Technology Co.,Ltd.(SZEB) is a leading supplier of high quality pharmaceutical impurities,API related compounds,intermediates,labeled standards and impurity custom synthesis services.E-mail:sales@ex-biotech.com.
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AI Product Description
*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Loxoprofen Ring-opening Impurity is a critical degradation byproduct formed during the synthesis or storage of the NSAID loxoprofen. It arises from the hydrolytic cleavage of the lactone ring structure. <strong>Molecular Formula: C15H18O4</strong>. <strong>CAS No: 127096-55-1</strong>. This impurity is strictly monitored in pharmaceutical manufacturing to ensure drug safety and compliance with ICH guidelines.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Serves as a reference standard for HPLC method validation and impurity profiling in finished pharmaceutical products.</li>
<li><strong>R&D:</strong> Utilized in stability studies to determine optimal packaging and shelf-life parameters for loxoprofen formulations.</li>
<li><strong>Regulatory Compliance:</strong> Essential for generating analytical data required by FDA and EMA submissions regarding genotoxicity risks.</li>
</ul>
<h3>Precautions</h3>
<p>Store at -20°C under inert atmosphere to prevent hydrolysis. Handle with appropriate PPE including nitrile gloves and eye protection due to potential irritancy. Do not use in clinical settings; this material is for laboratory analysis only.</p>