International Tables for Crystallography

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Powder diffraction and pharmaceuticals
J. Bernstein and S. M. Reutzel-Edens. International Tables for Crystallography (2019). Vol. H, ch. 7.5, pp. 767-781  [ doi:10.1107/97809553602060000979 ]

Abstract

The vast majority of pharmaceutically active ingredients, as well as the excipients employed in formulating pills, tablets and capsules, are solids. The generally preferred analytical technique for the characterization and identification of those solids is X-ray powder diffraction (XRPD). XRPD is employed in virtually every stage of the life cycle of pharmaceutical products, from the early crystal-form screening to monitoring a pilot plant and full production scale up. It often plays a crucial role in the quality control of production batches and assessment of product stability over time (shelf life). XRPD data are used to characterize the solid-state forms for defining patent claims on crystal forms and are also used in monitoring and litigating alleged patent infringements. XRPD is playing an increasingly important role in detecting and monitoring counterfeit drug products as well as in the characterization of the amorphous and crystalline character of a solid form. Examples of these various aspects of the application of XRPD to pharmaceuticals are given.


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About International Tables for Crystallography

International Tables for Crystallography is the definitive resource and reference work for crystallography. The multi-volume series comprises articles and tables of data relevant to crystallographic research and to applications of crystallographic methods in all sciences concerned with the structure and properties of materials.