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Practical Application of the Quality by Design Principles to the Development of an HPLC Assay Method for an API and Impurities

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The method for the assay of an active pharmaceutical ingredient (API) and five known and unknown impurities was developed in accordance to Quality by Design (QbD) principles. Highly influential separation parameters were simultaneously and systematically studied so that the quality of the HPLC method could be understood, controlled and ensured.

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