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Drug Impurity Profiling

Meaning

Drug impurity profiling is a rigorous analytical process used to identify, quantify, and characterize all non-active chemical substances present within a pharmaceutical compound, particularly compounded or bioidentical hormonal preparations. This scientific procedure is essential for ensuring the safety and quality of therapeutic agents by detecting potentially harmful contaminants, residual solvents, or degradation products. For compounded hormones, robust impurity profiling confirms that the patient is receiving a pure and stable product that meets stringent pharmacological standards.