*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p>Folic Acid EP Impurity C Calcium Salt is a defined reference standard used in pharmaceutical quality control. It serves as a degradation product or synthetic byproduct of folic acid, utilized to validate assay methods under European Pharmacopoeia guidelines. The compound features a calcium salt structure derived from the pteridine core. <strong>Molecular Formula</strong>: C19H20CaN8O7; <strong>CAS No.</strong>: 6451-88-9.</p>
<h3>Application</h3>
<ul>
<li><strong>Quality Control:</strong> Used for system suitability testing and impurity profiling in bulk drug substances.</li>
<li><strong>R&D:</strong> Supports stability-indicating method development for folate-based therapeutics.</li>
<li><strong>Regulatory Compliance:</strong> Essential for dossier submissions ensuring adherence to ICH Q3B impurity thresholds.</li>
</ul>
<h3>Precautions</h3>
<p>Store in a cool, dry place away from direct sunlight at temperatures between 2°C and 8°C. Handle with appropriate PPE to avoid inhalation or skin contact. Not intended for clinical administration; strictly for laboratory use only.</p>