日期记录: September 30 2020
Process and storage conditions can result in polymorphic conversions that turn a stable, efficacious drug substance into an unwanted structural analog. X-Ray powder diffraction (XRPD) can detect polymorphic changes induced by storage time, or temperature or relative humidity variations. Furthermore, there are various steps in the manufacturing process, such as compaction, milling, etc., which can alter the structure of active pharmaceutical ingredients (APIs), excipients or other components of a formulation.
Modern high-end diffractometers detect the slightest changes in formulation composition. However, in order to ensure the efficacy of a pharmaceutical product it is not sufficient to simply detect and identify the undesired forms - it is vital to assess their quantities in order to estimate their impact on the drug product’s performance.
In this webinar, we will demonstrate how a Quality by Design (QbD) approach can help when transferring XRPD methods from the development to manufacturing stages of the pharmaceutical production process. Setting meaningful and realistic specifications is an important step in ensuring robust quality control processes according to Good Laboratory / Manufacturing Practices (GLP / GMP), and this approach aims to provide appropriate methods to support quality control assessments and make sure that products meet their target performance profiles.