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Purity Specifications

Meaning

Purity specifications are the rigorously defined qualitative and quantitative standards that dictate the acceptable composition of a pharmaceutical agent, supplement, or raw material. These specifications establish the minimum concentration required for the active pharmaceutical ingredient (API) and the maximum permissible levels for impurities, contaminants, and residual solvents. Adherence to these strict standards is essential for ensuring the product’s safety, stability, and predictable clinical efficacy. In the hormonal health domain, precise purity is non-negotiable for achieving accurate dosing and minimizing adverse effects.