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.
발표자
Natalia Dadivanyan Ph.D - Application Specialist XRD
자세한 내용
Who should attend?
- Anyone engaged in developing methods for XRPD, developing pharmaceutical formulations, stability studies, chemical development or support of scale up activities.
- Anyone engaged in polymorph screening activities as part of lead optimization activities or producing/setting specifications for pharmaceutical raw materials or intermediates.
What will you learn?
- How XRPD can be applied within pharmaceutical development
- Why polymorphism is important for pharmaceutical products
- About the regulatory guidance related to XRPD
- How to perform stability studies by means of in situ X-ray diffraction testing.
- What advanced XRPD applications are, and why they are important for the characterization of (nano)crystalline and amorphous materials.