XRPD

Pharmaceutical and biopharmaceutical development and manufacturing is becoming more complex and expensive. The need for more elaborate material characterization and tighter quality control requirements combined with tighter time constraints places considerable demands on analysis. Rapid non-destructive analytical techniques such as near-infrared spectroscopy (NIR), X-ray diffraction (XRD) and X-ray fluorescence spectrometry (XRF) have a wide range of (bio-)pharmaceutical applications including drug discovery, pre-formulation, formulation, stability testing and final product quality control. The main advantage these techniques provide is a reduction in analysis time providing higher throughput which can lower costs and shorten the time to market. X-Ray Powder Diffraction (XRPD) continues to be an indispensable analytical technique supporting a wide variety of pharmaceutical development activities. X-ray powder diffraction (XRPD) is a core technique for the identification and characterization of solid pharmaceutical materials in terms of the structural order or disorder of solid APIs or other substances. Solid forms of a given molecule exhibiting long-range crystalline order (e.g., polymorphs, solvates, co-crystals, and salts) can be identified and characterized using XRPD by their unique combination of order parameters and well defined sharp diffraction peaks. Different phases, or polymorphs, within a particular material can be distinguished from one another by their unique X-ray powder diffraction (XRPD) patterns. Forming a key technique in our suite of physical characterization capabilities, Contract Analytical Service providers apply XRD to crystal morphology requirements supporting drug development, regulatory submission data and GMP lot release. They also provide GLP compliant XRD services. Advances in PXRD instrumentation and software have improved the efficacy of pharmaceutical drugs, efficiency of solid state characterization and rapid analysis of composites and materials. Variable temperature and humidity techniques are especially powerful in understanding structural changes of pharmaceutical drugs to enhance the stability and screen the drug substances under variable conditions. Ongoing developments involving structure determination directly from PXRD are encouraging to determine the crystal structures of new synthesized compounds and in pharmaceuticals. XRD in association with DSC, TGA, DTA, FTIR techniques can solve numerous problems encountered in industries for pharmaceutical formulation and pharmaceutic developments. The excellence of this technique is catering to academic research and commercial use in industries. Powder X-Ray Diffraction technique is a key analytical technique to serve the growth and development of Science and Technology.