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Potency

Potency testing analyzes the active pharmaceutical ingredient(s) in preparations and measures their concentrations or amounts. When testing for potency, the concentration of active ingredient is measured using a reference standard. Eagle Analytical Services performs potency tests by using state of the art High Pressure Liquid Chromatography (HPLC) equipped to a PDA detector, Ultra High Pressure Liquid Chromatography (UHPLC) equipped to a PDA, and Corona Detector and Spectrographic instrumentation. These instrumentations are the preferred methods for pharmaceutical analysis. Protocols have been developed based on USP <621> Chromatography and USP <851> Spectrophotometry and Light-Scattering methodology.

USP Chapter <795> states: “… Compound preparations are to be prepared to ensure that each preparation shall contain not less than 90% and not more than 110% of the theoretically calculated and labeled quantity of an active ingredient.

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