Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product.

The work mainly focused on a validation of the method for determining the content of salicylic acid and individual unknown impurities in new pharmaceutical product-tablets containing: 75, 100 or 150 mg of acetylsalicylic acid and glycine in the amount of 40 mg for each dosage. The separation of the components was carried out by means of HPLC, using a Waters Symmetry C18 column (4.6 × 250 mm, 5 µm) as the stationary phase. The mobile phase consisted of a mixture of 85% orthophosphoric acid, acetonitrile and purified water (2:400:600 V/V/V). Detection was carried out at a wavelength of 237 nm, with a constant flow rate of 1.0 ml min-1. In order to verify the method, linearity, precision (repeatability and reproducibility), accuracy, specificity, range, robustness, system precision, stability of the test and standard solution, limit of quantification and forced degradation were determined. Validation tests were performed in accordance with ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines. The method was validated successfully. It was confirmed that the method in a tested range of 0.005-0.40% salicylic acid with respect to acetylsalicylic acid content is linear, precise and accurate.

The Quality of Emulsions with New Synthetized Lipids Stabilized by Xanthan Gum.

The study investigated the quality of emulsions containing rabbit fat modified with vegetable oil. The modification of the fat and introducing it as a fatty base into the emulsion was dictated by consumer preferences. Emulsion systems containing various fatty bases and viscosity modifier contents were evaluated in the terms of their stability (by means of Turbiscan test), texture properties, color, and viscosity. Moreover, the emulsions were assessed by a sensory panel in the context of the intensity of the following parameters: color, fragrance, consistency, greasiness, and hydration. The same characteristics were also subject to consumer evaluation. The results of the sensory assessment showed the sensory panel attributed higher scores to consistency and skin hydration to the emulsions formed with modified fats; these systems were more appreciated by consumers as well. The results confirmed a major role of sensory determinations in the development of new emulsion products. They also provide knowledge on modifications to product characteristics that would lead to the best possible quality and consumer acceptance. This research has also reaffirmed that looking for new fats among waste fats is becoming a solution to finding new fatty bases for emulsions. The natural origin of these components, and thus their agreeability with the human body, appear noteworthy as well. Enrichment with unsaturated fatty acids is an added advantage of the enzymatic modification of rabbit fat with pumpkin seed oil and can be applied not only for food but also for skin applications.

Identifying the location of odour nuisance emitters using spatial GIS analyses.

The primary objective of the article was to establish the location of odour emitters with the use of spatial GIS analyses. The odour emitter location analysis based on measurements was carried out using QGIS software tools. The algorithm of the procedure was developed by analysing vector elements, including simulated odour streaks (in the form of wedge buffer surfaces) and a regular grid of points needed to determine the presence of a given buffer in a given location. Statistical analysis was performed in ArcGIS software. The detailed aim of the conducted study was to analyse the nuisance of odours from the measurement data on the basis of IDW interpolation and the arrangement of buildings. An innovative element of the developed analysis is the application of the inversed method of fragrance streak propagation. Identifying a streak from the measuring point towards the blowing wind is very likely to determine the approximate location of the odour emitter measured. The described method should provide better results at the location of emitters than the above mentioned methods using interpolation, because of taking into account wind direction and speed. In addition, it is a method that can be applied over a large open area where methods based on simulation and particle propagation would not be efficient or highly impossible to apply due to extensive and complex analysis. It was necessary to conduct field studies in order to meet the main goal, which resulted in sensory evaluation of the intensity of odour nuisance in an urbanised area. Odour concentration tests using field olfactometry with NasalRanger olfactometer were taken.