• Title/Summary/Keyword: inter-laboratory test

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Development of Dissolution Test Method for Acebrophylline Capsules and Bromhexine Hydrochloride Tablets in Korean Pharmaceutical Codex (고시수재 의약품 중 아세브로필린 캡슐 및 브롬헥신염산염 정의 용출시험법 개발)

  • Lee, Tae-Woong;Jeong, Rae-Seok;Jeong, Seung-A;Kim, Jeong-Hyun;Shim, Young-Hun;Kim, In-Kyu;Park, Chang-Won
    • YAKHAK HOEJI
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    • v.57 no.3
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    • pp.226-233
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    • 2013
  • Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specification in Korean Pharmaceutical Codex (KPC). So, with each reference and test drugs, the dissolution test method and an analytical procedure by HPLC were developed and validated to establish dissolution specification for acebrophylline capsules and bromhexine hydrochloride tablets. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Ministry of Food and Drug Safety (MFDS). The analytical method of HPLC was validated in specificity, linearity, precision and accuracy. Final dissolution test was performed with commercially available samples of 3 lots to establish specification. In addition, no difference was observed by the inter-laboratory evaluation. Dissolution specifications and conditions will be used for revising the monograph of acebrophylline capsules and bromhexine hydrochloride tablets in next supplement of KPC.

The Past, Present, Future of Newborn Screening in Korea (한국 신생아 집단검사의 과거, 현재, 미래)

  • Lee, Dong Hwan
    • Journal of The Korean Society of Inherited Metabolic disease
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    • v.14 no.1
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    • pp.1-9
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    • 2014
  • Many inborn errors of metabolism can be completely cured with early detection and early treatment. This is why neonatal screening on inborn errors of metabolism is implemented worldwide. In 1991, the Ministry of Health & Social affairs adopted a nationwide service program for neonatal screening of phenylketonuria, galactosemia, maple syrup urine disease, homocystinuria, histidinemia and congenital hypothyroidism for newborns delivered from low class pregnant women registered in health centers. Government decreased the test items from six to two, PKU and congenital hypothyroidism to increase test numbers with same budget from 1995. 78 laboratories wanted to participate for neonatal screening test in 1999. Government decided to screen six items of PKU, congenital hypothyroidism, maple syrup urine disease, homocystinuria, galactosemia and congenital adrenal hyperplasia from 2006. In 2014, thirteen laboratories are participating. Inter laboratory quality control was started 6 times a year from 1994. In case a patient with an inherited metabolic disease is diagnosed by screening of government program, special milk is provided at government's expense. According to the government project, from 1997 to 2013, 7,080,569 newborns were screened. 144 PKU, 2.451 congenital hypothyroidism were detected. So incidence of PKU is 1/49,170 and congenital hypothyroidism is 1/2,888. The cost benefit of performing screening procedures coupled with treatment has been estimated to be as high as 1.77 times in PKU, 11.11 times in congenital hypothyroidism than cost without screening. By January 2007, many European countries had expanded of their newborn screening programs by inclusion of Tandem mass spectrometry. We are trying to increase the budget to test all newborns for Tandem mass spectrometry from 2016. We are considering four to five central laboratories which cover all newborns and are equipped with tandem mass spectrometer & enzyme immunoassay for TSH, 17OHP & enzyme colorimetric assay for galactose. And I hope to expand test including Wilson disease screening test and lysosomal storage diseases.

0.1 MW Test Bed CO2 Capture Studies with New Absorbent (KoSol-5) (신 흡수제(KoSol-5)를 적용한 0.1 MW급 Test Bed CO2 포집 성능시험)

  • Lee, Junghyun;Kim, Beom-Ju;Shin, Su Hyun;kwak, No-Sang;Lee, Dong Woog;Lee, Ji Hyun;Shim, Jae-Goo
    • Applied Chemistry for Engineering
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    • v.27 no.4
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    • pp.391-396
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    • 2016
  • The absorption efficiency of amine $CO_2$ absorbent (KoSol-5) developed by KEPCO research institute was evaluated using a 0.1 MW test bed. The performance of post-combustion technology to capture two tons of $CO_2$ per day from a slipstream of the flue gas from a 500 MW coal-fired power station was first confirmed in Korea. Also the analysis of the absorbent regeneration energy was conducted to suggest the reliable data for the KoSol-5 absorbent performance. And we tested energy reduction effects by improving the absorption tower inter-cooling system. Overall results showed that the $CO_2$ removal rate met the technical guideline ($CO_2$ removal rate : 90%) suggested by IEA-GHG. Also the regeneration energy of the KoSol-5 showed about $3.05GJ/tonCO_2$ which was about 25% reduction in the regeneration energy compared to that of using the commercial absorbent MEA (Monoethanolamine). Based on current experiments, the KoSol-5 absorbent showed high efficiency for $CO_2$ capture. It is expected that the application of KoSol-5 to commercial scale $CO_2$ capture plants could dramatically reduce $CO_2$ capture costs.

Establishment of an Analytical Method for Azorubine, an Undesignated Food Colorant in Korea

  • Kim, Min-ji;Park, Ju-hee;Suh, Hee-Jae;Lee, Chan
    • Journal of Food Hygiene and Safety
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    • v.31 no.5
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    • pp.311-318
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    • 2016
  • Azorubine is a synthetic tar color containing azo-bond in the molecular structure. This food colorant has been allowed to be used for beverages, cheese and dried fruits in the European Union and for some food in Australia. Even though it is applicable as a food color in many countries, this compound has not been permitted in Korea so far as a food additive. Thus, this study was performed to establish an analysis method for azorubine in Korea by comparison of three HPLC analysis methods for azorubine and other azo-compounds which are officially used in the European Food Safety Authority (EFSA, EU), the Food Standard Agency (FSA, England) and the National Institute of Food and Drug Safety Evaluation (NIFDS, Korea). The analysis method of the FSA for azorubine showed the best linearity ($r^2=0.999$), limit of detection (LOD, $0.07{\mu}g/mL$), limit of quantification (LOQ, $0.20{\mu}g/mL$), precision (0~0.5%) and accuracy (98.6~100.7%) among tested HPLC methods using a C-18 column and diode array detector (DAD) with ammonium acetate solution and acetonitrile as an eluent solution. Finally selected method of FSA was further verified by inter-day and intra-day experiments with linearity, LOD, LOQ, precision and accuracy. Recovery test showed the recover ratios of 97~103%, 95~101%, and 93~102% in beverages, breads/snacks and other foods, respectively. Inter-laboratory test represented the absolute value of z-score of less than 2 which means satisfactory levels in this test. Selected method of FSA showed reliable analytical results in application test using food samples collected in commercial markets in Europe.

Real-time hybrid simulation of a multi-story wood shear wall with first-story experimental substructure incorporating a rate-dependent seismic energy dissipation device

  • Shao, Xiaoyun;van de Lindt, John;Bahmani, Pouria;Pang, Weichiang;Ziaei, Ershad;Symans, Michael;Tian, Jingjing;Dao, Thang
    • Smart Structures and Systems
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    • v.14 no.6
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    • pp.1031-1054
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    • 2014
  • Real-time hybrid simulation (RTHS) of a stacked wood shear wall retrofitted with a rate-dependent seismic energy dissipation device (viscous damper) was conducted at the newly constructed Structural Engineering Laboratory at the University of Alabama. This paper describes the implementation process of the RTHS focusing on the controller scheme development. An incremental approach was adopted starting from a controller for the conventional slow pseudodynamic hybrid simulation and evolving to the one applicable for RTHS. Both benchmark-scale and full-scale tests are discussed to provide a roadmap for future RTHS implementation at different laboratories and/or on different structural systems. The developed RTHS controller was applied to study the effect of a rate-dependent energy dissipation device on the seismic performance of a multi-story wood shear wall system. The test specimen, setup, program and results are presented with emphasis given to inter-story drift response. At 100% DBE the RTHS showed that the multi-story shear wall with the damper had 32% less inter-story drift and was noticeably less damaged than its un-damped specimen counterpart.

Quality Control on Neutron Activation Analysis for Urban Dust by the Proficiency Test (비교숙련도 시험을 통한 도시대기분진에 대한 중성자방사화분석법의 품질관리)

  • Moon, Jong-Hwa;Kim, Sun-Ha;Chung, Yong-Sam
    • Analytical Science and Technology
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    • v.15 no.5
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    • pp.433-438
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    • 2002
  • Trace elements in two air filters (V-50, P-50) artificially loaded with urban dust provided from IAEA were determined non-destructively using instrumental neutron activation analysis. Standard reference material (Urban Particulate Matter, SRM 1648) of National Institute of Standard and Technology was used for analytical quality control. About 20 elements in both of loaded filter samples were determined. To evaluate inter-laboratory comparison and proficiency test, analytical data were statistically treated with the results which collected from 49 laboratories, 40 countries participated in this study using neutron activation analysis, particle induced X-ray emission, inductively coupled plasma mass spectroscopy, etc,. From the results of statistical treatment, Z-scores are within ${\pm}2$. Furthermore, accuracy and precision of obtained analytical values are passed according to the criteria of the proficiency test. Consequently, it was proved that analytical quality for air dust samples being performed has been controlled properly.

An Inter-Laboratory Comparison Study on Chlorophyll a Determination in Seawater (해수 중 엽록소 a 측정방법에 대한 실험실 간 비교연구)

  • Moon, Cho-Rong;Kang, Dong-Jin;Park, Mi-Ok;Noh, Jae Hoon;Yoo, In-Jae;Moon, Jeong-Eon;Shin, Kyung-Hoon;Kim, Yun Sook;Choi, Joong-Ki;Suh, Young Sang
    • The Sea:JOURNAL OF THE KOREAN SOCIETY OF OCEANOGRAPHY
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    • v.19 no.1
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    • pp.76-87
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    • 2014
  • Chlorophyll a in seawater which is an indicator of phytoplankton biomass and primary production is determined by High Performance Liquid Chromatography (HPLC), Fluorometry and Spectrophotometry. In this study, various methods for chlorophyll a determination in seawater are compared using in situ seawater samples from Korean seas. Three inter-laboratory comparison campaigns were carried out using chlorophyll a standard samples (R0) and in situ seawater samples, collected from the East China Sea (R1) and the East Sea (R2). 6 laboratories by HPLC methods, 4 laboratories by fluorometry, and 3 laboratories by spectrophotometry participated. Precisions, defined as the coefficient of variation (CV) were within 9% in standard samples, 0.8~20% (average: 6.1%) in R1, 4~21% (average: 13.2%) in R2. Discrepancy in three methods was approximately 20% within the range of the sample homogeneity intended the laboratory precision (R1: 8%, R2: 15%). The discrepancy in laboratories was greater than the discrepancy in methods. The chlorophyll a concentrations can be produced within 20% discrepancy in spite of using different methods. It is recommended to consider this 20% discrepancy when using the chlorophyll a data produced by different laboratories and different methods.

Bioavailability Test of TestoTM Tablets (Methyltestosterone, 25 mg) in Male Healthy Volunteers by a Gas-chromatography/Mass Selective Detector

  • Kwon, Oh-Seung;Kim, Hye-Jung;Pyo, Hee-Soo;Kim, Dae-Duk;Chung, Youn-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.5
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    • pp.383-388
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    • 2005
  • A simple and specific method for determination of methyltestosterone (MT) has been established by a gas chromatography/mass selective detector and applied in plasma of healthy male volunteers received a single oral dose of 50 mg MT $(Testo^{TM}\;tablets,\;25\;mg)$ for bioavailability test. This method involves using liquid-liquid extraction of the sample with diethyl ether and derivatization with MSTFA. MT showed good resolution in this condition. The detection limit of quantitation was 5 ng/ml. A good linearity (r>0.996) was obtained at the range of 5-250 ng/ml of MT. Intra-day precision and accuracy were 2.76-12.56% and 0.39-8.01 %, and inter-day precision and accuracy were 2.29-17.69% and 0.42-7.99%, respectively. The established method was applied on bioavailability test of MT in human volunteers. The value of $AUC_{0\;to\;last}$ to last was $264.5{\pm}123.9\;ng{\cdot}hr/ml$ and that of $AUC_{0\;to\;inf}$ was determined to be $275.2{\pm}126.5\;ng{\cdot}hr/ml$. The values of $C_{max}$ and $T_{max}$ were $95.9{\pm}67.1\;ng/ml$ and $1.13{\pm}0.9\;hr$, respectively. The mean elimination half-life $(t_{1/2})$ was $4.4{\pm}0.9\;hr$. This analytical method is suitable and useful for the pharmacokinetics and bioequivalence studies of MT.

Mechanics of the slaking of shales

  • Vallejo, Luis E.
    • Geomechanics and Engineering
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    • v.3 no.3
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    • pp.219-231
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    • 2011
  • Waste fills resulting from coal mining should consist of large, free-draining sedimentary rocks fragments. The successful performance of these fills is related to the strength and durability of the individual rock fragments. When fills are made of shale fragments, some fragments will be durable and some will degrade into soil particles resulting from slaking and inter-particle point loads. The degraded material fills the voids between the intact fragments, and results in settlement. A laboratory program with point load and slake durability tests as well as thin section examination of sixty-eight shale samples from the Appalachian region of the United States revealed that pore micro-geometry has a major influence on degradation. Under saturated and unsaturated conditions, the shales absorb water, and the air in their pores is compressed, breaking the shales. This breakage was more pronounced in shales with smooth pore boundaries and having a diameter equal to or smaller than 0.060 mm. If the pore walls were rough, the air-pressure breaking mechanism was not effective. However, pore roughness (measured by the fractal dimension) had a detrimental effect on point load resistance. This study indicated that the optimum shales to resist both slaking as well as point loads are those that have pores with a fractal dimension equal to 1.425 and a diameter equal to or smaller than 0.06 mm.

여천지역 준설.매립토의 침강압밀 특성

  • Song, Jeong-Rak;Baek, Seung-Hun;Yeo, Yu-Hyeon
    • Proceedings of the Korean Geotechical Society Conference
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    • 1992.10a
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    • pp.55-60
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    • 1992
  • Hydraulically filled ground is formed by the settling of soil grains from the mixture of soil grains and water. It was generally known that the settling speed of the soil grains in governed by Stokes low. In the case of clayed dredged material, the shape of soil grains is not round, the surface of the soil grains is relatively large compared to the weight of soil grains and inter-grain ionic force is relatively large compared to the wight of soil grains. By this reason the settling and consolidation behavior of hydraulically filled quite different from that of Stokes law. This study investigated the settling and consolidation behavior of hydraulically filled materials of Yeochon industrial complex by large scale laboratory settling & consolidation container. The test results showed tat actual settling speed of soil grains in quite large compared to that of Stokes law. It was turned out that this phenomenon was due to the aggregation of soil grains. Also, it was truned out that the void ration and water content after the completion of settling process was 8.7 and 322% respectively. The consolidtion settlement of clayey hydraulic fill material was predicated better by "incremental small strain" consolidation concept than classical Terzaghj's consolidation concept (infinitesimal strain).

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