X-Ray Powder Diffraction (XRPD) is a powerful technique that uses the diffraction of X-rays on powder or microcrystalline samples for structural characterization. The use of synchrotron radiation (SR-XRPD) allows:
- An improved indexing and structure solution
- A substantial lower level of detection of mixture components (< 0.05 % wt)
- Very fast measurements (msec), ideal for kinetic analyses
Typical applications of SR-XRPD include:
- Structural solution of the solid form of new molecular entities during screening and selection processes
- Development of formulation and screening of excipients, including co-crystals
- Quality-by-design (QbD) approach for drug development
- Patent application for new materials and patent-life extension
- Characterization and high-accuracy quantification of all polymorphic forms in a drug substance and drug product, including in fully opaque blisters and in the presence of crystalline excipients.
- Detection of impurities down to a trace level (< 0.05% wt)
- Bi-dimensional distribution of drug substance polymorphs and excipients in a tablet
- Optimization of manufacturing processes, in particular crystallization, formulation, drying, lyophilization, wet granulation, tabletting and packaging operations.
- In situ non-ambient kinetic studies at milli-sec scale.
- Stability studies of polymorphic forms
- Continued Process Verification, in order to "maintain the process in a state of control over the life of the process" and "to continually improve [the] process", by performing "process improvement and innovation through sound science", as required by the new FDA guidance on process validation (FDA, 2011)
- Comparability studies following process changes or technology transfers
- Troubleshooting activities and investigations during commercial manufacturing
- Detection of counterfeits even with minute differences
More information on the applications for SR-XRPD can be found here.