*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Isoniazid Impurity 2, also known as Nicotinic Acid EP Impurity E, is a critical reference standard used in pharmaceutical quality control. It serves as an organic impurity arising from the <strong>synthesis process</strong> of Isoniazid. The chemical structure is defined by the molecular formula C6H5NO2 and CAS No. 59-67-6.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Assurance:</strong> Used for method validation and identification in HPLC analysis.</li>
<li><strong>Regulatory Compliance:</strong> Essential for meeting ICH Q3A/B guidelines on drug substance impurities.</li>
<li><strong>R&D:</strong> Supports stability studies to monitor degradation pathways during storage.</li>
</ul>
<h3>Precautions</h3>
<p>This substance must be stored in a cool, dry place away from direct sunlight. Personnel should handle it with appropriate PPE to avoid inhalation or skin contact. Strict adherence to local safety regulations regarding pharmaceutical intermediates is required.</p>