• Title/Summary/Keyword: Acceptable limits

Search Result 234, Processing Time 0.029 seconds

Pharmacokinetic and Bioequivalence Study of Zolpidem Tartate in Healthy Volunteers

  • Park, Jun-Sung;Myung, Ja-Hye;Wang, Hun-Sik;Koo, Ja-Seong;Cho, Won-Kyung;Cha, Kwang-Ho;Park, Hee-Jun;Kim, Min-So;Kim, Jeong-Soo;Hwang, Sung-Joo
    • Journal of Pharmaceutical Investigation
    • /
    • v.41 no.3
    • /
    • pp.191-196
    • /
    • 2011
  • In this study simple and sensitive high performance liquid chromatographic method using a commercially available column, was developed and validated for the determination of zolpidem tartrate in human plasma. The developed method with suitable validation was applied to a bioequivalence study of two different kinds of zolpidem tartrate. Two different formulations containing 10 mg of zolpidem tartate (CAS : 99294-93-6) were compared in 24 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, cross-over design in 24 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 12 h. The mean $AUC_{0-12h}$, $C_{max}$, $T_{max}$ and $T_{1/2}$ were $676.6{\pm}223.4$ $ng{\cdot}h{\cdot}mL^{-1}$, $177.4{\pm}34.2$ $ng{\cdot}mL^{-1}$, and $0.8{\pm}0.4$ and $3.5{\pm}2.1$, respectively, for the test formulations, and $640.7{\pm}186.6$ $ng{\cdot}h{\cdot}mL^{-1}$, $193.0{\pm}64.5$ $ng{\cdot}mL^{-1}$, and $0.9{\pm}0.4$ and $2.7{\pm}0.9$, respectively, for the reference formulation. Both primary target parameters $AUC_{0-12h}$ and $C_{max}$ were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of $AUC_{0-12h}$ and $C_{max}$ were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of zolpidem tartate are considered to be bioequivalent.

Characteristics of Pesticide Residues in Leafy Vegetables Collected from Wholesale and Traditional Markets in Cheongju (청주지역 도매시장과 재래시장 유통 엽채류 중 농약의 잔류 특성)

  • Noh, Hyun-Ho;Lee, Kwang-Hun;Lee, Jae-Yun;Park, Hyo-Kyoung;Park, So-Hyun;Kim, Sun-Ho;Kyung, Kee-Sung
    • The Korean Journal of Pesticide Science
    • /
    • v.15 no.4
    • /
    • pp.453-462
    • /
    • 2011
  • This study was carried out to survey the residual characteristics of pesticides and assess their safety. Nineteen agricultural commodities, collected from wholesale and traditional markets in Cheongju. Nineteen agricultural commodities including perilla leaves were collected from the markets on October 29th, 2010. Total 240 pesticides which can be analyzed by multiresidue analysis method by GLC and HPLC were monitored and the pesticides detected were confirmed by GC-MSD and LC-MS. Five pesticides, alachlor, bifenthrin, endosulfan, procymidone and triflumizole, were detected from five samples, such as welsh onion, leek and celery in case of wholesale market and perilla leaves and welsh onion in case of traditional market. Detection rate of 13.2% was obtained as a result of pesticide analysis but 2.6% of the pesticides detected exceeded their maximum residue limits. The estimated daily intakes (EDIs) and maximum permissible intakes (MPIs) of the pesticides detected were less than 26% and 0.05% of their acceptable daily intakes (ADIs) respectively, representing that residue levels of the pesticides detected would be safe.

The Transport Characteristics of 238U, 232Th, 226Ra, and 40K in the Production Cycle of Phosphate Rock

  • Jung, Yoonhee;Lim, Jong-Myoung;Ji, Young-Yong;Chung, Kun Ho;Kang, Mun Ja
    • Journal of Radiation Protection and Research
    • /
    • v.42 no.1
    • /
    • pp.33-41
    • /
    • 2017
  • Background: Phosphate rock and its by-product are widely used in various industries to produce phosphoric acid, gypsum, gypsum board, and fertilizer. Owing to its high level of natural radioactive nuclides (e.g., $^{238}U$ and $^{226}Ra$), the radiological safety of workers who work with phosphate rock should be systematically managed. In this study, $^{238}U$, $^{232}Th$, $^{226}Ra$, and $^{40}K$ levels were measured to analyze the transport characteristics of these radionuclides in the production cycle of phosphate rock. Materials and Methods: Energy dispersive X-ray fluorescence and gamma spectrometry were used to determine the activity of $^{238}U$, $^{232}Th$, $^{226}Ra$, and $^{40}K$. To evaluate the extent of secular disequilibrium, the analytical results were compared using statistical methods. Finally, the distribution of radioactivity across different stages of the phosphate rock production cycle was evaluated. Results and Discussion: The concentration ratios of $^{226}Ra$ and $^{238}U$ in phosphate rock were close to 1.0, while those found in gypsum and fertilizer were extremely different, reflecting disequilibrium after the chemical reaction process. The nuclide with the highest activity level in the production cycle of phosphate rock was $^{40}K$, and the median $^{40}K$ activity was $8.972Bq{\cdot}g^{-1}$ and $1.496Bq{\cdot}g^{-1}$, respectively. For the $^{238}U$ series, the activity of $^{238}U$ and $^{226}Ra$ was greatest in phosphate rock, and the distribution of activity values clearly showed the transport characteristics of the radionuclides, both for the byproducts of the decay sequences and for their final products. Conclusion: Although the activity of $^{40}K$ in k-related fertilizer was relatively high, it made a relatively low contribution to the total radiological effect. However, the activity levels of $^{226}Ra$ and $^{238}U$ in phosphate rock were found to be relatively high, near the upper end of the acceptable limits. Therefore, it is necessary to systematically manage the radiological safety of workers engaged in phosphate rock processing.

The Need for Weight Optimization by Design of Rolling Stock Vehicles

  • Ainoussa, Amar
    • International Journal of Railway
    • /
    • v.2 no.3
    • /
    • pp.124-126
    • /
    • 2009
  • Energy savings can be achieved with optimum energy consumptions, brake energy regeneration, efficient energy storage (onboard, line side), and primarily with light weight vehicles. Over the last few years, the rolling stock industry has experienced a marked increase in eco-awareness and needs for lower life cycle energy consumption costs. For rolling stock vehicle designers and engineers, weight has always been a critical design parameter. It is often specified directly or indirectly as contractual requirements. These requirements are usually expressed in terms of specified axle load limits, braking deceleration levels and/or demands for optimum energy consumptions. The contractual requirements for lower weights are becoming increasingly more stringent. Light weight vehicles with optimized strength to weight ratios are achievable through proven design processes. The primary driving processes consist of: $\bullet$ material selection to best contribute to the intended functionality and performance $\bullet$ design and design optimization to secure the intended functionality and performance $\bullet$ weight control processes to deliver the intended functionality and performance Aluminium has become the material of choice for modern light weight bodyshells. Steel sub-structures and in particular high strength steels are also used where high strength - high elongation characteristics out way the use of aluminium. With the improved characteristics and responses of composites against tire and smoke, small and large composite materials made components are also found in greater quantities in today's railway vehicles. Full scale hybrid composite rolling stock vehicles are being developed and tested. While an "overdesigned" bodyshell may be deemed as acceptable from a structural point of view, it can, in reality, be a weight saving missed opportunity. The conventional pass/fail structural criteria and existing passenger payload definitions promote conservative designs but they do not necessarily imply optimum lightweight designs. The weight to strength design optimization should be a fundamental design driving factor rather than a feeble post design activity. It should be more than a belated attempt to mitigate against contractual weight penalties. The weight control process must be rigorous, responsible, with achievable goals and above all must be integral to the design process. It should not be a mere tabulation of weights for the sole-purpose of predicting the axle loads and wheel balances compliance. The present paper explores and discusses the topics quoted above with a view to strengthen the recommendations and needs for the weight optimization by design approach as a pro-active design activity for the rolling stock industry at large.

  • PDF

The Exposure Risk Assessment of Residual Pesticides in Tea (다류에 존재하는 잔류농약 노출 안전성 평가)

  • Kim, Jae-Kwan;Oh, Moon-Seog;Kim, Ki-Yu;Kim, Yeong-Su;Son, Mi-Hee;Bae, Ho-Jung;Kang, Chung-Won;Park, Young-Bok;Yoon, Mi-Hye;Lee, Jong-Bok;Jeong, Ju-Yeon
    • The Korean Journal of Pesticide Science
    • /
    • v.15 no.1
    • /
    • pp.28-35
    • /
    • 2011
  • The investigation of 218 residual pesticides for 19 types of tea (persimmon leaf tea, chrysanthemum tea, green tea, lavender tea, rosemary tea, dandelion leaf tea, puer tea, mulberry leaf tea, hydrangea leaf tea, jasmine tea, nuomixiang tea, buckwheat tea, mugwort tea, lotus leaf tea, oolong tea, longjing tea, rose tea, tiehkwanyin tea and huoguo tea) obtained from markets in Ansan and Suwon was carried out to assess the risk for residual pesticides in tea. The detection rate was 23.1 % (19 samples of total 65 tea samples) and the detected pesticides were 15 pesticides, such as bifenthrin, bromopropylate, chlorpyrifos, cyhalothrin, cypermethrin, chlorfenapyr, dicofol, endosulfan, fenpropathrin, fludioxonil, fenvalerate, iprobenfos, isoprothiolane, tetradifon and triazophos. The range of concentrations for the detected residual pesticides was 0.01 to 1.24 mg/kg which showed below their maximum residue limits (MRL), but the residual concentration of bifenthrin in a puer tea showed above the legal limit of 0.3 mg/kg. The result of risk assessment of residual pesticides for the detected 15 samples showed that EDI (estimated daily intake) of the pesticides detected ranged 0.0001~0.0844% of their ADI (acceptable daily intake).

Determination of Statistical Sampling Plans for Bacillus cereus in Salad and Kimbab (샐러드와 김밥의 Bacillus cereus 분석에 의한 통계적 검체채취 계획 수립)

  • Lim, Goo-Sang;Koo, Minseon;Kim, Hyun-Jung;Kho, Young-Ho;Park, Kun-Sang;Oh, Se-Wook
    • Journal of Food Hygiene and Safety
    • /
    • v.29 no.1
    • /
    • pp.16-20
    • /
    • 2014
  • The prevalence of Bacillus cereus was determined in salad and Kimbab obtained from commercial retailers. Among the 100 salad samples analyzed, 54 samples were negative for B. cereus, whereas the bacterial count was < 10 colony forming units (CFU)/g in 8 samples, < 100 CFU/g in 25 samples, < 1,000 CFU/g in 11 samples, and > 1,000 CFU/g in 2 samples. The mean (standard deviation) was 1.18 log CFU/g (${\pm}0.71$ log CFU/g). In Kimbab, B. cereus was isolated from 20 samples; the mean bacterial count was 1.01 log CFU/g (${\pm}0.71$ log CFU/g). On the basis of the monitoring data, a statistical sampling plan was determined with the NEW sampleplan program (ICMSF), which was used as an analytical tool. To identify the most suitable sampling plan, the microbial limits (m, M) and the maximum allowable number of sample units yielding unsatisfactory test results (c) were varied, but the number of samples units, n = 5, was fixed. Sampling plans showing an acceptable probability (Pa) over 0.95 were considered suitable. Two plans (A and B) were finally suggested. Parameters for plan A are n = 5, c = 0, m = 1,000, and M = 10,000 and for plan B are n = 5, c = 2, m = 100, and M = 1,000. Interestingly, the latter plan was identical to the microbial sampling plan used in New Zealand. Thus, it was concluded that the suggested plan can be used as a sampling plan that is in line with international standards.

A Study on the Build of Equipment Predictive Maintenance Solutions Based on On-device Edge Computer

  • Lee, Yong-Hwan;Suh, Jin-Hyung
    • Journal of the Korea Society of Computer and Information
    • /
    • v.25 no.4
    • /
    • pp.165-172
    • /
    • 2020
  • In this paper we propose an uses on-device-based edge computing technology and big data analysis methods through the use of on-device-based edge computing technology and analysis of big data, which are distributed computing paradigms that introduce computations and storage devices where necessary to solve problems such as transmission delays that occur when data is transmitted to central centers and processed in current general smart factories. However, even if edge computing-based technology is applied in practice, the increase in devices on the network edge will result in large amounts of data being transferred to the data center, resulting in the network band reaching its limits, which, despite the improvement of network technology, does not guarantee acceptable transfer speeds and response times, which are critical requirements for many applications. It provides the basis for developing into an AI-based facility prediction conservation analysis tool that can apply deep learning suitable for big data in the future by supporting intelligent facility management that can support productivity growth through research that can be applied to the field of facility preservation and smart factory industry with integrated hardware technology that can accommodate these requirements and factory management and control technology.

Heavy Metal(loid) Levels in Paddy Soils and Brown Rice in Korea

  • Kunhikrishnan, Anitha;Go, Woo-Ri;Park, Jin-Hee;Kim, Kwon-Rae;Kim, Hyuck-Soo;Kim, Kye-Hoon;Kim, Won-Il;Cho, Nam-Jun
    • Korean Journal of Soil Science and Fertilizer
    • /
    • v.48 no.5
    • /
    • pp.515-521
    • /
    • 2015
  • There is an increasing concern over heavy metal(loid) contamination of soil in agricultural areas including paddy soils. This study was conducted to monitor the background levels of heavy metal(loid)s, arsenic (As), cadmium (Cd), copper (Cu), mercury (Hg), nickel (Ni), lead (Pb), and zinc (Zn) in major rice growing soils and its accumulation in brown rice in Korea. The samples were collected from 82 sites nationwide in the year 2012. The mean and range values of As, Cd, Cu, Hg, Ni, Pb, and Zn in paddy soils were 4.41 (0.16-18.9), 0.25 (0.04-0.82), 13.24 (3.46-27.8), 0.047 (0.01-0.20), 13.60 (3.78-35.0), 21.31 (8.47-36.7), and 54.10 $(19.19-103.0)mg\;kg^{-1}$, respectively. This result indicated that the heavy metal(loid) levels in all sampled paddy soils are within the permissible limits of the Korean Soil Environment Conservation Act. The mean and range values of As, Cd, Cu, Hg, Ni, Pb, and Zn in brown rice were 0.146 (0.04-0.38), 0.024 (0.003-0.141), 4.27 (1.26-16.98), 0.0024 (0.001-0.008), 0.345 (0.04-2.77), 0.113 (0.04-0.197), and 22.64 $(14.1-35.1)mg\;kg^{-1}$, respectively. The mean and range BCF (bioconcentration factor) values of As, Cd, Cu, Hg, Ni, Pb, and Zn in brown rice were 0.101 (0.01-0.91), 0.121 (0.01-0.70), 0.399 (0.05-2.60), 0.061 (0.016-0.180), 0.033 (0.004-0.44), 0.005 (0.003-0.013), and 0.473 (0.19-1.07), respectively, with Zn showing the highest. The results show that the levels of all metal(loid)s in all sampled brown rice are generally within the acceptable limit for human consumption.

Determination of β-Carotene in Infant Formulas by High-Performance Liquid Chromatography (HPLC를 이용한 조제유류 중 베타카로틴 함량 분석 연구)

  • Hwang, Kyung Mi;Bae, Ji Won;Hu, Soo Jung;Oh, Keum Soon
    • Journal of Food Hygiene and Safety
    • /
    • v.34 no.4
    • /
    • pp.334-339
    • /
    • 2019
  • A procedure based on high-performance liquid chromatography (HPLC) is described to determine ${\beta}-carotene$ in infant formulas. The method for ${\beta}-carotene$ analysis was performed on a C18 reversed-phase column using acetonitrile/methanol/dichloromethane (6:1:3, v/v/v) as a mobile phase. ${\beta}-Carotene$ was determined in HPLC with photo diode array (PDA) detector. The parameters of validation were specificity, linearity, LOD, LOQ, accuracy, precision and repeatability. The specificity was confirmed by the retention time and the linearity ($R^2$), which was over 0.999 in the range of 0.125~2 mg/L. The detection and quantification limits were 0.064 and 0.193 mg/L, respectively. The accuracy and precision of this method using an STD spiked sample were 80~119% and 1.02~2.05% respectively. The method was applied to the analysis of various infant formula and follow-up formulas products containing ${\beta}-carotene$, and all the products contained acceptable levels of ${\beta}-carotene$ for nutrition labeling.

Improvement of Analysis Methods for Fatty Acids in Infant Formula by Gas Chromatography Flame-Ionization Detector (GC-FID를 이용한 조제유류 중 지방산 분석법 개선 연구)

  • Hwang, Keum Hee;Choi, Won Hee;Hu, Soo Jung;Lee, Hye young;Hwang, Kyung Mi
    • Journal of Food Hygiene and Safety
    • /
    • v.36 no.1
    • /
    • pp.34-41
    • /
    • 2021
  • The purpose of this research is to improve analysis methods of determining the contents of fatty acids in infant formulas and follow-up formulas. A gas chromatography (GC) method was performed on a GC system coupled to flame ionization detector, with a fused silica capillary column (SP2560, 100 m×0.25 mm, 0.20 ㎛). The method was validated using standard reference material (SRM, NIST 1849a). Performance parameters for method validation such as specificity, linearity, limits of detection (LOD) and quantification (LOQ), accuracy and precision were examined. The linearity of standard solution with correlation coefficient was higher than 0.999 in the range of 0.1-5 mg/mL. The LOD and LOQ were 0.01-0.06 mg/mL and 0.03-0.2 mg/mL, respectively. The recovery using standard reference material was confirmed and the precision was found to be between 0.8% and 2.9% relative standard deviation (RSD). Optimized methods were applied in sample analysis to verify the reliability. All the tested products had acceptable contents of fatty acids compared with component specification for nutrition labeling. The result of this research will provide efficient experimental information and strengthen the management of nutrients in infant formula and follow-up formula.