DEVELOPMENT AND VALIDATION OF METHOD OF QUANTITATIVE DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN INNOVATIVE ACTIVE PHARMACEUTICAL INGREDIENT WITH GC-FID

The aim of the study was to develop and validate a new method of quantitative determination of residual organic solvents in a substance A using GLC. Studies were carried out with gas chromatography with a flame ionization detector and sampling from the vapor phase. The effect of the polarity of the stationary phase for the chromatographic separation of the organic solvents peaks: Chloroform, Ethanol, Methylene Chloride, Cyclohexane, Ethyl Acetate, Methanol, N, N-dimethylformamide, 2-propanol was investigated. Chromatographic separation of Ethanol, Methanol, 2-propanol, Ethyl Acetate, Methylene Chloride and Cyclohexane was performed with quartz capillary column DB-624, 30 m × 0.20 mm, 1.8 micron; Chloroform and N, N-dimethylformamide – DB-WAX, 30 m × 0.50 mm, 0.25 mm. System suitability criteria and the validity of method were determined. Method has high specificity, precision, linearity, sensitivity and reliability

Critical Points for the Production of Polymeric Microspheres Used in X-Ray Surgery

Introduction. Saturated polymer microspheres represent one of the leading developments in the field of chemoembolization. Due to the complicated multi-stage production in the Russian market, mainly foreign manufacturers of these products are represented, which may indicate the relevance of studying this topic.Aim. The aim of the work was to develop a technological scheme for the production of polymer microspheres and a description of critical control points of production.Materials and methods. The study of the intermediate product was carried out using a Levenhuk D320L microscope (Levenhuk Inc, USA). Analysis of production control points was carried out by the HACCP (Hazard analysis and critical control points) method.Results and discussion. As a result of the study, the main technological stages of the production of microspheres, which are a copolymer of vinyl alcohol and sodium acrylate, have been identified and described. For each technological stage, control critical points are determined with an indication of the controlled parameters and control methods. The photographs of the intermediate product at intermediate stages are shown.Conclusion. A technological scheme for the production of microspheres has been developed. The analysis of critical control points of the stages of the main production process is carried out. Identified irreversible critical points of production

THE PROCEDURE OF ACTIVE PHARMACEUTICAL INGREDIENT SUPPLIERS PRELIMINARY CHOICE FOR MEDICINE MANUFACTURE

The paper demonstrates application of the newly developed procedure for pre-selection of suppliers of active pharmaceutical ingredient to manufacture of drugs using the tools of risk analysis. The procedure allows to organize the process of selecting suppliers, to reduce the risk of acquiring the substance non-pharmacopoeia quality, to minimize the consumption of cost, time and manpower resources for qualifying manufacturers, to form a reasonable list of manufacturers to audit their production sites

O R I G I NA L A RT I C L E Optimization study of spray detonation initiation by electric discharges

Abstract Development of air-breathing pulse detonation engines is faced with a challenging problem of detonation initiation in fuel sprays at distances feasible for propulsion applications. Extensive experimental study on initiation of a confined n-hexane spray detonation in air by electric discharges is reported. It is found that for direct initiation of spray detonation with minimal energy requirements (1) it is worth to use one discharger located near the closed end of a detonation tube and at least one additional discharger downstream from it to be triggered in-phase with primary shock wave arrival; (2) the discharge area should be properly insulated to avoid electric loss to metal tube walls; (3) discharge duration should be minimized to at least 50 µs; (4) discharge channel should preferably occupy a large portion of a tube cross-section; (5) test tube should be preferably of a diameter close to the limiting tube diameter; (6) gradual transition between the volume with electric discharger and the tube should be used; and (7) a powerful electric discharger utilized for generating a primary shock wave can be replaced by a primary shock wave generator comprising a relatively low-energy electric discharger, Shchelkin spiral, and tube coil. With all these principles implemented, the rated electric energy of about 100 J was required to initiate n-hexane spray-air detonation in a 28-mm tube at a distance of about 1 m from the atomizer. Keywords Detonation initiation · Liquid-fuel spray · Electric discharge · Pulse detonation engin

PhysChB5_07Basevich_IILO

Abstract -A mathematical model of steady laminar flame propagation through a suspension of liquid droplets was proposed, and numerical calculations within the framework of this model were performed. The model is constructed based on one-dimensional differential equations of the theory of laminar flames in homogeneous gaseous mixtures in conjunction with the theory of droplet burning in uniform monodisperse suspensions. The chemical process was described using a multistage kinetic scheme. A comparison of model predictions with the available experimental data demonstrated satisfactory agreement