記録された日時: August 26 2020
Conducting proper solid form analysis is a very important part of the daily routine in the pharmaceutical research and industry. Being one of the most powerful methods of solid form characterization, X-ray Powder Diffraction (XRPD) allows in the Early Development stage not only to select the most promising lead candidates for the Active Pharmaceutical Ingredient (API), but also to choose the right solid form to proceed with. Depending on their solubility and permeability, APIs can be developed in crystalline form, as a nanosuspension or as an amorphous solid dispersion. Once the solid form has been selected, it’s structure and stability have to be assessed using a variety of X-ray diffraction and scattering techniques. Maintaining these forms throughout the whole Drug Development, while the formulation and process parameters are being defined and optimized is on the critical path to regulatory filing and approval. Finally, upon Manufacturing, product quality must be validated. For this purpose, as well as for Troubleshooting, XRPD experiments can be the source of valuable information when ensuring that a product meets its target performance profile.
When selecting an X-ray diffractometer, it is critical to choose a platform that provides reliable results in an efficient manner, making it possible not only to identify and quantify sample composition, but also to achieve low limits of detection for polymorphic and other impurities. Special care has to be taken when looking into method transfer to achieve a flowless transition to the new instrumentation. Other relevant attributes are upgradable and capabable of conducting experiments in both R+D and QC environment strictly following the regulatory guidance and good manufacturing and laboratory practices (GMP +amp;amp; GLP).
In this web-seminar we will introduce Malvern Panalytical X-ray diffraction and scattering portfolio, highlighting the novel developments in the field of X-ray applications, e.g. optical components, data analysis and sample handling, paying special attention to the services that Malvern Panalytical is offering to ensure a smooth transition for our customers.