The assessment of the quality parameters of inulin active pharmaceutical ingredients according to physicochemical characteristics

N. M. Smielova, O. A. Yevtifieieva, S. M. Gubar

Abstract


Aim. To assess the quality parameters of plant active pharmaceutical ingredients (API) in accordance with the requirements of modern normative documents by such physicochemical characteristics as “Description”, “Solubility”, “Hygroscopy”, “Microscopy”, as well as identification of the structural components of fructan in order to involve the data obtained in development of the national normative documents on the substance of inulin.
Results. The study of nine plant API of inulin obtained from chicory, agave and Jerusalem artichoke, as well as the reference standards of fructan from chicory and dahlia has been conducted by such physicochemical characteristics as “Description”, “Solubility”, “Hygroscopy”, “Microscopy”.
According to the British Pharmacopoeia 2010 (BP) the chemical reactions of identification confirmed the presence of fructose and glucose after hydrolysis of the substance. According to the United States Pharmacopeia 36 – NF 31 (USP) it has been found by the identification reaction that the substances analyzed (in addition to the standard substances) contain impurities of sugars with the properties of reducing agents. By appearance the samples under study are loose, amorphous powders of practically white and pale yellow color, they are hygroscopic and very hygroscopic, readily soluble and very soluble in hot water. By the microscopic study they are completely or partially fragmented spherical or ovoid fractions with the expressed central micelles and peripheral semi-transparent shells, as well as small parts separated from the main pseudocrystalline formations.
Conclusions. The results of studying the substances of inulin by such physicochemical characteristics as “Description”, “Solubility”, “Hygroscopy”, “Microscopy”, as well as identification of the structural components of fructan according to the requirements of the BP and USP, can be used for the input quality control of plant API of inulin to confirm the structure and determine the purity of the substance. The results of studying the physicochemical characteristics of plant API of inulin can be used when developing the national normative documents on the substance of inulin.


Keywords


inulin; description; solubility; hygroscopy; microscopy; identification; quality control

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DOI: https://doi.org/10.24959/uekj.18.12

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