X-RAY DIFFRACTION METHOD OF IDENTIFYING BATCHES OF PHARMACEUTICAL PRODUCTS Russian patent published in 2012 - IPC G01N23/20 

FIELD: physics.

SUBSTANCE: sample is irradiated with monochromatic X-ray radiation; the diffraction pattern from the sample is recorded in form of a profile of intensity of the diffraction X-ray radiation at different diffraction angles; diffraction peaks are selected; characteristics of the selected diffraction peaks are compared with similar characteristics of reference samples, from where phase composition of the analysed sample is determined; wherein for analysis, a series of samples is collected from each batch of the pharmaceutical product, said samples being in solid form and having packaging; each sample of the series with an intact structure is scanned without breaching the packaging; diffraction peaks corresponding to the packaging material are selected on the diffraction pattern; the range of angles for analysing the diffracted radiation is set, within which diffraction peaks for the material of each sample are selected, from which, using statistical methods, the identity of the corresponding series of samples, one of which is the reference, to one batch of the pharmaceutical product is established, and by selecting a standard series of the pharmaceutical product of a given manufacturer as the reference series, the authenticity of the pharmaceutical product is determined, wherein the wavelength of the monochromatic X-ray radiation is selected based on characteristics of the packaging material.

EFFECT: possibility of rapid analysis during investigation, identification and authentication of batches of pharmaceutical products in packaging.

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