Pharmaceutical Excipient Characterization

The aim of formulation development is to design a product and its manufacturing process to consistently deliver the intended Quality Target Product Profile (QTPP). This involves determining the Critical Quality Attributes (CQAs) for the Active Pharmaceutical Ingredient (API) and excipients that define the performance of the product. These are generally identified through an assessment of the extent to which the variation in a specific attribute, for example particle size, can impact the drug product’s quality and performance.

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