Date recorded: July 07 2020
Solid form analysis plays a vital role in materials characterization throughout the pharmaceutical development cycle. X-ray Powder Diffraction (XRPD), one of the solid form analysis methods, is a comprehensive technique which is used to ensure that a product meets its target performance profile.
In the early stages (Discovery and API Development), XRPD is an important tool for polymorph selection, and confirmation of polymorphic stability over time. Presence of an undesired polymorph could lead to a reduction in therapeutic benefit, due to changes in solubility of the Active Pharmaceutical Ingredient (API) and may even cause an adverse effect in the patient. During Formulation and Process Development / Optimization, stability and compatibility studies by means of (in situ) XRPD are crucial when optimizing the excipients and process parameters. Finally, during manufacturing, thorough control of both incoming goods and also formulations is critical for safeguarding the quality of the finished product.
This webinar will consider the pharmaceutical development workflow and map appropriate X-ray Diffraction and Scattering methods across the whole process. Furthermore, we will discuss how an appropriate method for XRPD analysis can be developed and implemented.