4H-Pyrido[1,2-a]pyrimidin-4-one, 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-9-pentadecyl-;Glycerol Impurity 64
*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Paliperidone Impurity refers to chemical byproducts or degradation products associated with the active pharmaceutical ingredient. These are typically synthesized via <strong>peptide coupling</strong> or <strong>oxidation pathways</strong> during manufacturing. The molecular formula is C<sub>20</sub>H<sub>24</sub>FN<sub>3</sub>O<sub>5</sub>, and specific variants possess CAS numbers such as 849137-66-2.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used as reference standards for HPLC method validation in GMP facilities.</li>
<li><strong>R&D:</strong> Employed in stability studies to identify degradation profiles of finished drugs.</li>
<li><strong>Regulatory Compliance:</strong> Essential for generating toxicological data required by FDA and EMA submissions.</li>
</ul>
<h3>Precautions</h3>
<p>Store strictly under <strong>inert atmosphere</strong> at temperatures below -20°C to prevent hydrolysis. Personnel must utilize appropriate PPE including respirators and chemical-resistant gloves due to potential sensitization risks. Do not use in clinical settings; restricted to laboratory analysis only.</p>