*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Nicorandil EP Impurity D is a critical reference standard used for the identification and quantification of degradation products in pharmaceutical formulations. Manufactured via controlled nitration and hydrolysis processes, its molecular formula is <strong>C10H12N4O5</strong> with CAS number <strong>107868-47-9</strong>. This impurity serves as a vital tool for ensuring drug purity compliance under European Pharmacopoeia guidelines.</p>
<h3>Application</h3>
<ul>
<li>Quality control testing in active pharmaceutical ingredient (API) manufacturing.</li>
<li>Stability-indicating method development and validation for Nicorandil tablets.</li>
<li>Regulatory submissions to verify impurity profiles during batch release.</li>
</ul>
<h3>Precautions</h3>
<p>Strict storage at -20°C in a desiccated environment is required to prevent hydrolysis. Personnel must handle this compound using appropriate PPE to avoid skin contact or inhalation due to potential mutagenic risks associated with nitro-compounds.</p>