• 품질경영학회지
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• 제36권1호
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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.

• 품질경영학회지
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• 제38권1호
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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.

• 한국지반환경공학회 논문집
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• 제23권9호
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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.

• Journal of Pharmaceutical Investigation
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• 제19권4호
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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.

• 생약학회지
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• 제50권4호
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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.

• 한국식품영양과학회지
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• 제30권2호
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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.

• 한국식품과학회지
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• 제37권4호
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• pp.597-602
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• 2005

인삼 유화 음료를 3가지 온도 조건에서 저장하면서 유화안정성, 당도, 진공도, pH, 산도, 색도(L, a, b값), 점도, 사포닌, 미생물 및 관능검사 등 총 10개 항목의 품질 요소들의 변화를 측정한 결과 저장기간 중 품질 변화가 크며 저장 온도에 따른 유의차를 나타내는 4가지 품질 지표인 유화 안정성, 산도, 점도, yellowness를 확인하였다. 품질 지표로 선정한 유화 안정성, 산도. 점도, yellowness의 온도 의존성을 Arrhenius식을 이용하여 판단한 결과, 점도의 경우 온도 의존성이 가장 큰 것으로 나타났으며, 유화 안정성의 경우 2단계로 변화가 일어나 저장 초기에 속도가 빠르고, 일정 기간 이후에 속도가 느렸다. 또한 산도 및 yellowness의 변화도 저장기간에 따라 변화하고 저장 온도에 따라 그 속도가 달라짐을 확인 할 수 있었다. 일반적으로 식품의 품질 변화의 온도 의존성을 나타내는 $Q_{10}$ value는 약 2의 값을 나타낸다고 하였으나, 본 연구에서 품질 지표로 선정된 4가지 요소의 $Q_{10}$ value는 각각 다른 값을 나타내었다. 이로 보아 같은 식품이라도 품질 인자에 따라 각기 다른 $Q_{10}$ value를 가지는 것을 알 수 있었으며, 일률적으로 $Q_{10}$ value를 적용하는 것은 적절하지 않음을 알 수 있었다.

• Environmental Sciences Bulletin of The Korean Environmental Sciences Society
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• 제3권2호
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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.

• Preventive Nutrition and Food Science
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• 제12권4호
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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.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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• pp.302.1-302.1
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• 2003

Accelerated stability testing was performed on the different 7 dosage forms in order to evaluate the influences of the existence of other vitamins, minerals, excipients on the chemical stability of vitamin A in complicated vitamin drug products. The stability results suggested that increasing of storage time and temperature has resulted in increasing the rate of vitamin A decomposition and the shelf lives(t$\sub$90/) under the test decreased as the storage temperature increased. (omitted)