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.
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.
The most important task of the dairy cattle industry is to obtain high quality raw milk. To achieve it, a set of measures is required, including aimed at increasing the biological safety of produced raw materials. The aim of the study was to create a scientific and methodological basis for the Bovine leukemia virus (BLV) gene diagnostics in a combined format of pathogen indication and identification. This required updating the strategy of BLV PCR-RFLP genotyping, consistent with its phylogenetic classification, taking into account the growing knowledge about the genetic diversity of 11 genotypes of the studied viral pathogen. When staging nested PCR, oligonucleotide primers were used, which initiate at the final stage of the reaction the production of a 444 bp env-gene fragment of the pathogen. Five restriction endonucleases were used in PCR-RFLP BLV genotyping of: PvuII, SspI, AsuHPI, HaeIII, and BstX2I. As a result of verification of the developed Bovine leukemia virus method for gene identification with an updated genotyping strategy, a technical result was obtained, expressed in the ability to identify all 11 BLV genotypes discovered to date by interpreting the generated 58 genotype-associated combinations of PCR-RFLP profiles.
Inflammatory diseases of the female genital area are dominant among the total number of gynecological diseases. Among all the variety of medicinal plant materials used in official medicine, salvia medicinal draws attention to itself, which has repeatedly proved its effectiveness in the treatment of inflammatory diseases of the mucous membranes of various origins. That is why the goal was set to develop a technology for obtaining a liquid extract from the leaves of Salvia officinalis L. As a result of the study, a method was developed for obtaining a liquid extract by selecting the optimal extraction conditions. It was found that the optimal raw material-extractant ratio is 1:50, the optimal concentration of the extractant ethyl alcohol is 70%, the infusion time of the extract is 24 hours. To intensify the extraction process, the method of ultrasonic processing of raw materials at the soaking stage was used. The optimal time for processing plant materials with ultrasound was 45 minutes. As a result of using this method to obtain a liquid extract from the leaves of sage officinalis, the yield of phenolic compounds was doubled in comparison with obtaining an extract without sonication of raw materials and amounted to 182.7 mg / g of flavonoids in terms of luteolin-7-glycoside.
Bovine cattle milk lactoferrin is industrially produced from cow’s milk and used in a variety of functional products, including baby food, nutritional supplements, dairy products, and veterinary drugs. The possibility of obtaining lactoferrin from lactic acid milk wheyrises a particular interest. The purpose of this study is to assess the possibility of using and adapting existing spectrophotometric methods for determining the concentration of total protein and an electrophoretic method for analyzing the protein composition of whey fractions and lactoferrin substances. A comparative study of two methods for determining the total protein in whey fractions and lactoferrin preparations biuret and Bradford method was carried out. The validation parameters of both methods were defined. An analytical range from 30 μg / ml to 1000 μg / ml characterizes the linearity of the Bradford method. The electrophoretic profile of milk, milk whey, whey fractions and substances of lactoferrinwere analyzed. The results obtained indicate a high information content of the electrophoretic method for characterizing the purification efficiency of whey fractions.
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