Objective. Organic solvents, which often have toxic and/or carcinogenic properties, are used at all stages of the production of pharmaceutical substances - synthesis, isolation and purification - and are not completely removed after the completion of the technological process. The presence of even extremely small amounts of such compounds in medicines can be dangerous for patients. The article presents the results of the development of a method for determining the content of residual organic solvents (ROS) - ethanol, toluene and dimethylformamide - in a new active pharmaceutical ingredient (API) 3-(1H-benzimidazol-2-yl)-1,2,2-trimethylcyclopentane-carboxylic acid by gas chromatography. Materials and methods. Static vapor phase analysis was used to identify and to quantify residual organic solvents. It was determined by the internal standard method using a Shimadzu GC-2014ATF/SPL gas chromatograph with an AOC-6000Plus autosampler; PID detection. Isobutyl alcohol was used as an internal standard. Results. The developed method was used to determine the content of residual organic solvents in the validation series of the new pharmaceutical substance 3-(1H-benzimidazol-2-yl)-1,2,2-trimethylcyclopentane-carboxylic acid. The method was validated in accordance with the requirements of the State Pharmacopoeia of the Russian Federation. Conclusion. The developed method is suitable for further use in quality control in the production of 3-(1H-benzimidazol-2-yl)-1,2,2-trimethylcyclopentane-carboxylic acid.
Introduction. Lactoferrin is a biologically active substance, a natural glycoprotein from the group of iron-containing proteins, transferrin. This article is devoted to a review of the literature data on the properties and prospects for the use of lactoferrin in medicine and veterinary medicine.Text. The problem of widespread use of lactoferrin is the need to use a large volume of raw materials, the difficulty of extracting it from agricultural raw materials and subsequent purification. In this view, at present, it is very promising to use transgenic animals to obtain such a valuable compound in the required volume. Discovered in 1939 in cow's milk, lactoferrin exhibits a wide spectrum of biological activity, new properties of this protein are constantly being established. The most studied are the immunomodulatory effects, anti-inflammatory, antimicrobial, antiviral, antifungal activities of lactoferrin, and the search for the possibility of using this compound for the treatment and prevention of the new coronavirus infection SARS-CoV-2, as well as for the prevention of postCOVID complications, has begun. In recent years, the antitumor activity of lactoferrin has been actively studied, as well as the prospects for its use as a biomarker for early diagnosis of neurodegenerative diseases. Lactoferrin can play a special role in the delivery of drugs to target organs, as well as in the manufacture of functional food products and various drugs for both humans and animals.Conclusion. Thus, the performed theoretical study and the data obtained on a wide spectrum of biological activity of lactoferrin confirm the prospects and expediency of the development of formulations and technology of drugs, functional food products, veterinary drugs and animal products based on lactoferrin.
The aim of this work is phytochemical studies and standardization of Scabiosa succisa L. By reverse phase high performance liquid chromatography of ethanol extract substances belonging to polyphenolic compounds were found, among which hydroxycinnamic acids predominate. Chlorogenic acid and flavonoid glycosides of apigenin and luteolin were identified. Microscopic analysis revealed the main diagnostic features of the Scabiosa succisa L. herb. As a result of research component composition of Scabiosa succisa L. polyphenols was partially installed, which substantiates its anti-inflammatory properties, and microdiagnostics signs were discovered, which can determine the plant authenticity.
The article presents the results of the elaboration of techniques for identification and assay of a new active pharmaceutical substance (API) – 3- (1H-benzimidazol-2-yl) -1,2,2-trimethylcyclopentane-carboxylic acid. To identify the API, the method of IR spectroscopy was used, the assay was carried out using the method of direct acidimetric titration in a medium of glacial acetic acid. Methods were validated in accordance with the requirements of the State Pharmacopoeia of the Russian Federation and are suitable for further use in quality control in the production of 3- (1H-benzimidazol-2-yl) -1,2,2-trimethylcyclopentane-carboxylic acid.
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