*The following content is generated by AI and is for reference only.
<h3>Overview</h3>
<p><strong>Progesterone EP Impurity C</strong> (17α-Hydroxyprogesterone) is a critical reference standard used for quality control in pharmaceutical manufacturing. Synthesized via microbial transformation or chemical oxidation of progesterone, it serves to validate purity profiles. <strong>Molecular Formula</strong>: C21H30O3; <strong>CAS No.</strong>: 67-79-4.</p>
<h3>Application</h3>
<ul>
<li>Pharmaceutical QC: Identification and quantification in progesterone drug substance batches.</li>
<li>Regulatory Compliance: Essential for meeting ICH Q3B guidelines on impurity thresholds.</li>
<li>Method Validation: Used to calibrate HPLC systems for potency testing.</li>
</ul>
<h3>Precautions</h3>
<p>Strictly limit exposure during handling to prevent dermal absorption. Store in sealed containers at -20°C under inert atmosphere to ensure stability. Do not use as a therapeutic agent.</p>