• Journal of Korean Society for Quality Management
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• v.36 no.1
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• pp.1-6
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• 2008

The purpose of stability study of pharmaceutical products is to establish the shelf life based on the change of the quality with time. Stability study generally consists of a random sample of dosage units from a batch or several batches placed in a storage room and periodically assayed for their drug content. The statistical methods of assessing the shelf-life of drug in the market is considered with the current KFDA regulations. An illustrated application to some stability data from the pharmaceutical industry is also presented with the discussion.

• Journal of Korean Society for Quality Management
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• v.38 no.1
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• pp.96-100
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• 2010

The shelf-life of pharmaceutical products is the time that the average product characteristic remains within an approved specification after manufacture. Since the true shelf-life of a drug product is typically unknown, it has to be estimated based on assay results of the drug characteristic from a stability study usually conducted during the process of drug development. The nonparametric statistical methods of assessing the shelf-life of drug are considered with the current FDA regulations. Some simulation studies of nonparametric methods are also presented with the discussion.

• Journal of the Korean GEO-environmental Society
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• v.23 no.9
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• pp.25-31
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• 2022

Attaching shelf to retaining structure leads to a decrease in the total lateral earth pressure. This decrease enables the retaining structures to become more stable, to have small displacement, and to exhibit lower bending moments, the relief shelves effects are analyzed using FEM in order to understand how they stabilize cantilever wall in this study. Several models are varied by changing location and width of shelves to realize earth pressure and displacements of retaining wall. The displacement is getting smaller because earth pressure acting on shelf increases as shelves locations are lower and width is longer. The ground settlement variation effects caused by relief shelves are studied also. The ground settlement increases abruptly where shelf location is between of 0.5H and 0.625H, and settlement decreases suddenly where shelf width is between b/h=0.375 and b/h=0.500. The shelf significantly reduces earth pressure and movement of the wall. This decrease in the lateral pressure increases the retaining structure stability.

• Korean Journal of Pharmacognosy
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• v.50 no.4
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• pp.318-323
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• 2019

This study was designed to establish the stability of EGHB010, a combined hot water extract of Paeoniae Radix and Glycyrrhizae Radix. Test of coliform groups, sensory evaluations, contents of moisture, and the amount of paeoniflorin and glycyrrhizin were determined during storage at 4, 25 and 35℃ for 6 months. Coliform groups were not observed and moisture contents were maintained about 3.0% during the storage period. Sensory characteristics including color, taste, texture and appearance were tested over 3 points throughout the entire storage period. It maintained the commercial value during the storage period. Contents of paeoniflorin and glycyrrhizin as indicator components were remained stably for the storage period. The shelf-life of EGHB010 based on a linear response to zero of sensory evaluation with the highest correlation coefficient was predicted. Finally, the shelf-life of EGHB010 was expected for about 3 years to consider in safety coefficient. The shelf-life data of EGHB010 can be used to develop a functional health ingredient.

• Journal of the Korean Society of Food Science and Nutrition
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• v.30 no.2
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• pp.364-367
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• 2001

We gamma-irradiated to natural casings from lamb and pork to improve sanitary quality and microbiological shelf stability of sausage stuffed in animal intestine-induced natural casing from lamb and pork. The microbial changes of irradiated casings and the microbial growth of the sausages with gamma-irradiated natural casings were observed. Population of total aerobic bacteria was decreased by gamma irradiation, dependent upon the irradiation dose. The number of microflora in lamb and pork casings was reduced by about 5.5 log cycle at 5 kGy. Population of total aerobic bacteria of sausages stuffed in non-irradiated lamb and pork casing was about 3.6 log CFU/g after just manufacture and was about 7 log after 10 day storage. However, population of total aerobic bacteria of sausages with 3 kGy-irradiated and 5 kGy-irradiated casings was 2.48 and 0.32 log in lamb, and 2.78 and 0.60 log in pork, respectively. Gamma irradiation to animal intestine- induced natural casings was effective and thus, can be used for enhancing shelf life of final products due to reduction of the number of contaminated microflora.

• Journal of Pharmaceutical Investigation
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• v.19 no.4
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• pp.213-217
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• 1989

To formulate the stable preparation of Gingko extract injection and to evaluate the stability of the preparation, Gingko extract aqueous solutions having various pH values were prepared and the stability of ginskoflavonglycoside (GFG) was investlfated by high performance liquid chromatography. The stability of GFG decreased as pH increased, while the water solubility of Gingko extract decreased as pH decreased. The optimal pH of the Gingko extract aqueous solution was found to be pH 6.5. The shelf life $(T_{90%})$ of the Gingko extract aqueous solution of pH 6.5 at $20^{\circ}C$ was extrapolated to be four years.

• Korean Journal of Food Science and Technology
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• v.37 no.4
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• pp.597-602
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• 2005

Quality factors of emulsified ginseng drink were determined during storage at various temperatures, and its shelf-life was predicted based on changes in emulsion stability, acidify, viscosity, and yellowness. Viscosity was highly dependent on storage temperature. Emulsion stability changed rapidly during early storage period (1st step), then slowly thereafter (2nd step). $Q_{10}$ values of emulsion stability were 2.50 and 1.38 for 1st and 2nd steps, respectively. Viscosity, acidity, and yellowness showed $Q_{10}$ values of 3.45, 1.77, and 1.99, respectively. Although $Q_{10}$ value of 2 has been generally used to predict shelf stability of food materials, our results suggest adopting same $Q_{10}$ value to predict shelf stability of emulsified ginseng drink is not appropriate.

• Preventive Nutrition and Food Science
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• v.12 no.4
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• pp.242-250
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• 2007

This study evaluated the storage stability of a variety of sauce products in the Korean market, determined primary quality indices for three typical products, and proposed functional relationships that are useful for determining shelf life at different temperatures. Most of the products examined were found to combine hurdles of low pH, low water activity, and the use of heat processing as methods for producing the required storage stability while maintaining the sensory quality of the products. For a meat extract solution produced for cold noodles (pH=4.3; $a_w=0.98$), the primary quality change determining shelf life was lipid oxidation, determined here by the TBA value. The primary quality index of a soybean paste seasoning mix (pH=4.0; $a_w=0.78$), which had a microbial load of 2.8 log (CFU/g), was a decrease in its pH. The primary quality index for a sandwich spread (pH=4.0; $a_w=0.88$) was changes in its surface color. The temperature dependence of changes in the primary quality indices can be described by the Arrhenius equation, which can estimate the shelf life at any arbitrary limit as a function of temperature. The activation energies for changes in the primary quality indices of the meat extract solution, the soybean paste seasoning, and the sandwich spread were 20.3, 27.2, and 43.5 kJ/mol, respectively.

• Korean Journal of Pharmacognosy
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• v.44 no.2
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• pp.200-208
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• 2013

The aim of this study was to evaluate the shelf-life of Bojungikgi-tang (Buzhongyiqi-tang in Chinese) by long-term storage test. Experiments were performed to evaluate the stability such as the selected physicochemical, pH, identification, heavy metal, microbiological experiment, and amount of marker compounds under a long-term storage test of Bojungikgi-tang decoction. The significant change was not showed in pH, heavy metal, microbiological, and identification test based on long-term storage test. Furthermore, the HPLC analysis was performed for the determinations of liquiritin, glycyrrhizin, nodakenin, and hesperidin in Bojungikgi-tang by long-term storage test. We were calculated shelf-life of Bojungikgi-tang decoction based on the amount change of four constituents. Consequently, Shelf-life by four compounds at room temperature was predicted 23 month. The suggested shelf-life would be helpful on the storage and distribution of herbal medicine.

• Environmental Sciences Bulletin of The Korean Environmental Sciences Society
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• v.3 no.2
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• pp.105-112
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• 1999

Density and temeprature fronts are common features of the ocean. However, frontal dynamics are not quasi-geostrophic because the isopycnal deflections associated with fronts are large compared with the scale height of the hydrostatic geopotential. The frontal geostrophic model, developed by Cushman-Roisin et al.(1992) is generally used fro describing the dynamics of surface-density ocean fronts, whereas the two-layer frontal geostrophic model is used for fronts on a sloping continental shelf. This paper investigates the baroclinic nonlinear stability of surface-density ocean fronts and fronts on a sloping continental shelf using the two-layer frontal geostrophic model mentioned above. Nonlinear stability criteria for the two kinds of fronts are obtained using Arnol'd's (1965; 1969) variational principle and a prior estimate method. This is the first time a nonlinear stability criterion for surface ocean fronts has been established, furthermore, the results obtained for fronts on a sloping bottom are superior to any previous ones.