Crystallics and Excelsus Announce Partnership in Synchrotron XRPD Technology
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Polymorphic forms can have a significant impact on the quality and performance of pharmaceutical and chemical products.  For pharmaceuticals, a thorough characterization of polymorphism of drug substance and drug product plays a key role throughout the entire life-cycle of the product.  Polymorphic studies also play an important role in patent litigations and in the fight against counterfeit drugs.

Picture 1. Synchrotron facility at the Swiss Light Source (Courtesy Paul Scherrer Institute)

Synchrotron Radiation X-Ray Powder Diffraction (SR-XRPD) offers a unique and powerful tool for polymorphic studies, such as the identification of closely related polymorphic forms, high-sensitivity quantitative phase analyses and kinetic analyses.  The use of advanced synchrotron facilities is in line with the regulatory expectations (ICH guidelines and FDA guidance) that newly available analytical technologies are used for continuous improvements in process understanding and product characterization.

Crystallics and Excelsus Structural Solutions SPRL (Excelsus) have announced a cooperation agreement where Crystallics will promote Excelsus’ synchrotron technology for solid-state characterization of pharmaceutical substances and products. Excelsus is a spin-off company of the Paul Scherrer Institute in Switzerland and is headed by Fabia Gozzo.

In the pharmaceutical industry, X-Ray Powder Diffraction (XRPD) is the “gold standard” technique for characterizing crystalline powders (drug substances and products, as well as, excipients). It is indeed a powerful tool that uses the diffraction of X-rays by polycrystalline samples for structural characterization.

Picture 2. High-resolution, fast and radiation-damage-controlled SR-XRPD analyses provided by Excelsus allow the DIRECT detection and quantification of traces of impurities below 0.05%wt in both nominally pure APIs and formulated drugs

Compared to XRPD the use of SR-XRPD allows:

- Improved indexing and structure solution
- Substantial lower level of detection of mixture components (< 0.05 % wt)
- Very fast measurements, ideal for kinetic analyses
- Broader range of applications (inorganics, organics and macromolecules)

Picture 3. Traditional sources (on the left) are able to detect the presence of impurities in acquisition times of the order of the minutes, but their univocal identification is questionable due to a combination of limited counting statistics and angular (FWHM) resolution. Fast SR-XRPD provided by Excelsus (on the right) provide a direct and univocal fingerprinting of impurities

For pharmaceuticals powders, SR-XRPD allows improved identification and studies of solid forms (polymorphs, solvates, hydrates, salts, co-crystals, amorphous) under various manufacturing and storage conditions, as requested by regulatory authorities (see ICH Q6A guidelines).

SR-XRPD is also a powerful technique for analysis of food and aroma compounds, cosmetics, pigments, catalysts, cement and various other chemicals.

For further information please contact Gunnar Staaf, CEO, on +31 20 820 2690 or This e-mail address is being protected from spambots. You need JavaScript enabled to view it