SR-XRPD Applications

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.