Driving XRD in regulated environments: Solid form analysis with XRDynamic 500
Solid form analysis is a critical step in drug development and quality control processes that helps to ensure final drug products meet all necessary performance and safety criteria. This is especially important for small molecule active pharmaceutical ingredients (APIs) which can arrange in different crystal structures (polymorphs) that may vary significantly in terms of their physicochemical properties. Selection of the correct polymorph is therefore vital and requires a deep understanding of the different possible structures and their stability over time or under various storage conditions during the development process.
Powder X-ray diffraction (XRD) is an ideal tool for solid form analysis, as different polymorphs can be easily identified due to changes in the diffraction pattern. It can therefore be used during development and in QC batch release testing to ensure the correct polymorph of a sample is present. Anton Paar’s XRD solutions offer 21 CFR Part 11 and GxP-compliant measurements with the highest sensitivity to even the smallest impurity phases.
In this webinar, you will get an overview of XRD for solid form analysis and how the method can be applied in regulated environments like the pharmaceutical industry. You will get insights into:
- How XRD can be applied to pharmaceutical materials
- New opportunities in solid form analysis made possible by next-gen XRD instrumentation
- How XRDynamic 500 supports the requirements of 21 CFR Part 11
- Application examples
Target group:
- Anyone interested in solid form analysis of pharmaceuticals via XRD
- Researchers who want to extend their polymorph screening capabilities with the latest instrumentation
- Lab managers looking to perform XRD measurements in a regulated environment
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