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V.V. Tihonova Post-graduate Student, Saint-Petersburg State Chemical Pharmaceutical University (Saint-Petersburg) E-mail: A.S. Saushkina Ph.D. (Pharm.), Associate Professor, Saint-Petersburg State Chemical Pharmaceutical University (Saint-Petersburg)

The Raman effect predicted in 1918 and experimentally confirmed in 1928 represents the ability of molecules to inelastic scattering of monochromatic light. Raman rays obtained after contact with the substance are separated by a light filter from the Rayleigh rays and their frequencies are recorded to collect spectral information about the sample. Based on this principle, Raman spectroscopy is an expressive non-destructive and universal analysis method for identifying objects in biology, medicine, pharmacy, forensic science, gemology, food industry, etc. The active introduction into the pharmaceutical production system of the system of process-analytical technologies (PAT) as a tool for compliance with GMP standards requires the development of analysis methods that allow you to quickly and fully control the quality of products at all stages of the pro-duction process. One of analytical methods that can successfully solve the problems of the modern pharmaceutical industry is Raman spectroscopy. In contrast to the methods of pharmaceutical analysis, the key advantages of Raman spectroscopy are the absence of sample preparation and small amounts of the research object, the possibility of obtaining information from the far IR region. It is compensated for during long-term continuous use due to the consumption of reagents, such as, for example, organic solvents. The method allows one to establish the quality of pharmaceutical sub-stances, both chemical and biological, to assess their purity and to determine the quantitative content of the target component. In addition, Raman spectroscopy combined with modern mathematical data methods makes possible to establish the completion moment of process run in closed reac-tors, as well as to promptly signal deviations in them. The article presents the results of a review of literature data reflecting the capabilities of Raman spectroscopy (Raman spectroscopy) for quality control of drugs and agents in process analysis technology (PAT).

quality control
process analytical technology

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