• 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.

• 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.

• 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.

• 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 Pharmacognosy
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• v.43 no.3
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• pp.257-264
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• 2012

The purpose of this study was to estimate the shelf-life of Ssanghwa-tang by long-term storage test. Experiments were conducted to evaluate the stability such as the selected physicochemical, pH, identification, heavy metal, microbiological experiment under a long-term storage test of Ssanghwa-tang. The significant change was not showed in pH, heavy metal, microbiological, identification test and quantitative analysis based on long-term storage test. The contents of albiflorin, paeoniflorin, cinnamic acid, liquiritin, and glycyrrhizin in long-term storage test were 66.8-93.1 ${\mu}g/mL$, 429.0-495.0 ${\mu}g/mL$, 3.8-4.4 ${\mu}g/mL$, 32.0-38.1 ${\mu}g/mL$, and 66.8-71.7 ${\mu}g/mL$, respectively. Shelf-lifes by 5 compounds about 3 lots at room temperature were predicted 21-37, 14-21, and 16-72 months, respectively. The suggested shelf-life would be helpful on the storage and distribution of herbal medicine.

• 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 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.

• Journal of the East Asian Society of Dietary Life
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• v.27 no.2
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• pp.194-203
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• 2017

Mealworm, a type of edible insect, is a superior food material suitable for industrial products. In this study, four different defatted mealworm powders were prepared to determine proper manufacturing conditions. Solvent extraction method reduced lipid contents of mealworms more than pressed mealworms, and lowered lipid contents caused bright colors and good physicochemical properties for powders. In comparison, differences among milling machines used for making powders were strongly related with average size of particles. Meanwhile, the predicted shelf-life of defatted mealworm powders judged by accelerated experiments was 1 year or longer. To enhance shelf-life of mealworm powders, addition of tocopherol to mealworm powders at a concentration of 0.2% could intensify oxidative stability and microbial inhibition.

• Journal of Pharmaceutical Investigation
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• v.25 no.1
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• pp.9-17
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• 1995

To stabilize omeprazole(OMP), ethylenediamine(ED) complex of omeprazole(OMPED) was prepared by reaction between OMP and ED in methanol, and the complex formation was confirmed by the instrumental analysis, i.e., IR, DSC, EA, NMR, MS and XRD. The rates of decomposition of OMP and OMPED in aqueous solution and the shelf lives at standard temperature were measured by accelerated stability analysis. The results are summarized as follows; The mole ratio of OMP and ED in OMPED complex is 1:1, the energy of formation within OMPED might be combined between polar imidazole group of OMP with induced a dipole amine group in the readily polarizable ED molecule. At standard temperature the degradation rate constant of OMP in aqueous solution is $2.540{\times}10^{-2}\;hr^{-1}$ and the shelf life is 4.15 hrs, and in the case of OMPED the degradation rate constant is $7.986{\times}10^{-4}\;hr^{-1}$ and the shelf life is 131.96 hrs. So, the OMPED has about 31 times longer shelf life than OMP. The activation energy of OMP and OMPED are 5.23 and 18.55 kcal $mole^{-1}$ respectively. The stability of OMP is dependent chiefly on pH in the solutions and it decomposes readily in acidic medium by hydrogen ion catalized reaction but becomes stable beyond pH 9.0. In case of the ED-complex, OMPED is stable in neutral as well as in dilute acidic solutions even in pH 6, OMPED is very stable to light(UV), that is, the rate constant and shelf life of OMP are $k=1.0188{\times}10^{-2}\;day^{-1}$, $T_{90%}=4.5 \;days$, on the other hand, the those of OMPED are $k=7.138{\times}10^{-4}\;day^{-1}$, $T_{90%}=64.1\;days$, respectively. From the above results, it is thought that new dosage forms could be developed by using the OMPED as a potential OMP complex.