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J Pharm Sci. 2020 Jan;109(1):891-899. doi: 10.1016/j.xphs.2019.07.008. Epub 2019 Jul 23.

A New Method Based on Electron Diffraction for Detecting Nanoparticles in Injectable Medicines.

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Center for Nanotechnology Innovation@NEST, Istituto Italiano di Tecnologia, Piazza San Silvestro 12, Pisa, Italy. Electronic address:
AsSIS, Associazione di Studi e Informazione sulla Salute, Via Firenze 8, Pisa, Italy.
Foundation for Salutogenesis, Viale della Repubblica 21, Bologna, Italy.


A new method for detecting and characterizing nanoparticles in an injectable pharmaceutical solution is presented. The method is based on the simultaneous use, on those nanoparticles that are crystalline, of three-dimensional electron diffraction tomography and energy dispersive X-ray spectrometry. With three-dimensional electron diffraction tomography, the unit cell and the crystal symmetry of the nanoparticles are determined, while with energy dispersive X-ray spectrometry, the chemical composition is derived. With these data, through an inspection of a crystallographic database, it is possible to determine the crystal phase of the nanoparticles. The knowledge of the crystal phase is a valuable element for understanding the provenance and the formation of the nanoparticles, helping the researcher in solving any quality control issue related to the presence of nanoparticles in an injectable solution.


electron diffraction; electron diffraction tomography; nanoparticles; pharmaceutical safety


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