• Title/Summary/Keyword: 표준적합성 시험

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Analytical Method Development for Determination of Coenzyme Q10 by LC-MS/MS in Related Health Functional Foods (건강기능식품에서 LC-MS/MS를 이용한 코엔자임Q10 분석법 연구)

  • Lee, Jin Hee;Oh, Mihyune
    • Journal of Food Hygiene and Safety
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    • v.34 no.6
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    • pp.519-525
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    • 2019
  • The Ministry of Food and Drug Safety (MFDS) is amending its test methods for health functional foods (dietary food supplements) to establish regulatory standards and specifications in Korea. In this regard, we are continuing our research on analytical method development for the items listed in the Korean Health Functional Food Codex. In this study, we have developed a sensitive and selective test method that could simultaneously separate and determine coenzyme Q10 based on liquid chromatographic-tandem mass spectrometry (LC-MS/MS). Calibration curves showed linearity with a correlation coefficient (R2) of > 0.999 and the limits of detection (LODs) and limits of quantitation (LOQs) were in the range of 26.0 ㎍/L and 78.9 ㎍/L, respectively. The recovery results ranged between 98.6-107.0% at 3 different concentration levels with relative standard deviations (RSDs) less than 5%. The proposed analytical method was characterized with high resolution of the coenzyme Q10 and the assay was fully validated as well.

Development of Multi-Purpose Containers for Managing LLW/VLLW from D&D (제염해체 방사성폐기물 관리를 위한 다목적 용기의 개발)

  • Lee, Jaesol;Park, Jeaho;Sung, Nakhoon;Yang, Gehyung
    • Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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    • v.14 no.2
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    • pp.157-168
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    • 2016
  • Radioactive waste container designs should comply with the requirements for safety (i.e., transportation, storage, disposal) and other criteria such as economics and technology. These criteria are also applicable to the future management of the large amount of LLW and VLLW to arise from decontamination and decommissioning (D&D) of nuclear power plants, which have different features compared to that of wastes from operation and maintenance (O&M). This paper proposes to develop a set of standard containers of multi-purpose usage for transportation, storage and disposal. The concepts of the containers were optimized for management of D&D wastes in consideration of national system for radioactive waste management, in particular the Gyeongju Repository and associated infrastructures. A set of prototype containers were designed and built : a soft bag for VLLW, two metallic containers for VLLW/LLW (a standard IP2 container for sea transport and ISO container for road transport). Safety analyses by simulation and tests of these designs show they are in compliance with the regulatory requirements. A further development of a container with concrete is foreseen for 2016.

A Study on Standardization of Data Bus for Modular Small Satellite (모듈화 소형위성의 Data Bus 표준화 방안 연구)

  • Jang, Yun-Uk;Chang, Young-Keun
    • Journal of the Korean Society for Aeronautical & Space Sciences
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    • v.38 no.6
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    • pp.620-628
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    • 2010
  • Small satellites can be used for various space research and scientific or educational purposes due to advantages in small size, low-cost, and rapid development. Small Satellites have many advantages of application to Responsive Space. Compared to traditional larger satellites, however, Small satellites have many constraints due to limitations in size. Therefore, it is difficult to expect high performance. To approach maximum capability with minimal size, weight, and cost, standard modular platform of Small satellites is necessary. Modularity supports plug-and-play architecture. The result is Small satellites that can be combined quickly and reliably using plug-and-play mechanisms. For communication between modules, standard bus interface is needed. Controller Area Network(CAN) protocol is considered optimum data bus for modular Small satellite. CAN can be applied to data communication with high reliability. Hence, design optimization and simplification can also be expected. For ease of assembly and integration, modular design can be considered. This paper proposes development method for standardized modular Small satellites, and describes design of data interface based on CAN and a method of testing for modularity.

새로운quinolone계 항균제의 경구용제제화 연구

  • 이규현;윤두선;홍종호;홍지웅;심영기;전인구
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 1994.04a
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    • pp.308-308
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    • 1994
  • 열분석 (DSC, TG/DTA)을 통해 Q-35는 A, B, C의 세가지 다형이 존재함을 알수 있었으며 이중 상대습도에 따른 흡습성의 변화가 적고, 가습에 의해 다형전환이 일어나지 않는 C형이 제제에 유리하다고 사료된다. 또한C형은 분쇄, 연합 및 타정에 의한 다형의 전환이 없었다. Q-35의 용해도는 물, 메탄올, 에탄올에 각각 0.30.3.55,6.31mg/m1 이었으며 PH5이상에서는 급격히 용해도가 감소하고 산성에서는 용해도가 크게 증가하는 양상을 나타냈다. 적층시험, 배합시험을 통해 선정한부형제의 표준 처방 혼합물로 정제를 저조한 결과Q-35의 성형성은 양호하였고 Q-35의 함량이 증가함에 따라 붕해시간이 다소 지 연됨을 알수 있었다. 그러나 Q-35원료는 유동성이 적어 직타법이 적합하지 않았으며, 습식 과립압축법에 따라 저조한 정제의 붕해시간은 5-9분, 15분 후 용출은 91.$\pm$5.0% 이었다. Q-35정제를 4$0^{\circ}C$, 4$0^{\circ}C$ ㆍ 75%RH에서 6개월, 6$0^{\circ}C$에서 3개월 보존후 함량을 측정한 결과 각각 100.0, 98.7, 98.9%이었으며 그밖의 항목에서도 안정한 결과를 얻어 Q-35정제는 온도 및 습도어 안정한 것으로 사료된다. 대량생산 연구결과 Q-35의 결정수가 이탈되지 않도록 건조, 코팅 공정 중 정제의 온도를 5$0^{\circ}C$ 이하로 유지시켰다.

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Design and Implementation of Supporting Tool for Medical Software Testing Certification (의료용 소프트웨어 시험 인증을 위한 지원도구의 설계 및 구현)

  • Hong Jung-Hun;Kim Hyuk-Joo;Yang Hae-Sool
    • Proceedings of the Korea Information Processing Society Conference
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    • 2004.10a
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    • pp.465-468
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    • 2004
  • 의료기기 산업은 시장규모와 생산규모에서 미국이 전 세계의 $40\%$ 이상을 차지하고 있어 국내외 모든 의료기기 제조업체에서는 미국시장진출을 목표로 꾸준히 노력하고 있는 실정이다. 그러나 의료기기는 인체에 직접 적용된다는 특성으로 인해 각 국가의 정부는 저마다 다른 엄격한 기준으로 자국내 시장진출을 규제하고 있으며 엄격한 관리제도를 유지하고 있다. 국내 최신의 전자 의료기기는 필수적으로 의료기기를 제어하기 위한 의료용 소프트웨어를 필요로 하므로 의료기기 산업의 발전은 의료용 소프트웨어 산업의 발전에 직결된다고 할 수 있다. 그러나 의료기기의 경우에는 인$\cdot$허가를 위한 제도 및 절차가 갖추어져 활용되고 있는 반면, 의료용 소프트웨어의 경우에는 적합한 평가기준이 마련되어 있지 못하여 제도 및 체계구축의 필요성이 대두되고 있다. 본 논문에서는 국제표준(ISO/IEC 12119, ISO/IEC 9126을 바탕으로 평가메트릭을 구축하여 의료용 소프트웨어의 정량적인 품질을 측정, 평가하여 품질측정의 결과를 토대로 품질을 인증하는 의료응용 소프트웨어 시험인증 지원도구를 설계 및 구현하였다.

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Test Case Generation of GSMP Protocol for Open Multiservice Switching System (개방형 멀티서비스 교환 시스템에서 GSMP의 시험열 생성 기법)

  • Lee, Hyun-Jeong;Choi, Young-Il;Lee, Byung-Sun;Jun, Kyung-Pyo
    • Proceedings of the Korea Information Processing Society Conference
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    • 2000.10b
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    • pp.1129-1132
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    • 2000
  • 최근 인터넷 수요의 증가로 통신망에서 음성, 영상 및 데이터(data)를 복합적으로 지원할 수 있는 멀티서비스(multiservice)의 교환 기술이 필수적이다. 또한 망 사업자들이 여러 벤더(vendor)들로부터 최적의 장비를 선택하여 망을 구축할 수 있도록 통신 장비들의 상호 운용성을 지원하는 개방형 구조의 망 및 스위치 시스템(switch system)을 정의하는 작업이 필요하다. 페트리 넷(Petri Nets)은 시스템(system)을 분석하기 위한 도구로서, 시스템은 페트리 넷 이론에 의해 시스템의 수학적 표현인 페트리 넷으로 설계될 수 있다. CPN(Colored Petri Nets)은 페트리넷의 확장형으로서, 토근(token)에 칼라를 부여하여 다양한 특성을 지닌 시스템을 표현하기에 적합하다. Design/CPN은 CPN의 사용을 지원하는 소프트웨어 패키지(software package)이다. 본 논문에서는 개방형 멀티서비스 교환 시스템의 핵심으로 스위치와 제어기(Controller) 사이의 표준 프로토콜인 GSMP(General Switch Management Protocol) 프로토콜을 Design/CPN 으로 변환하고, 이로부터 시험열을 생성한다.

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Confirmation of Schizandrin as a Marker Compound in Jangsu Omija Powder (HPLC를 이용한 기능성 원료 지표성분으로서 장수 오미자 분말 중 Schizandrin의 분석법 개발)

  • Kim, Yunjeong;Ha, Na;Han, Song-Hee;Jeon, Ji-Young;Hwang, Minho;Im, Yong-Jin;Lee, Sun Young;Chae, Soo-Wan;Kim, Min-Gul
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.42 no.2
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    • pp.244-248
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    • 2013
  • We studied the development of schizandrin as a marker compound in Jangsu Omija. Schizandrin was validated for its LOD (limit of detection), LOQ (limit of quantitation), precision, accuracy, and recovery by HPLC relative to Omija powder. It showed a high linearity in the calibration curve with a coefficient of correlation ($R^2$) of 0.9990. The LOD and LOQ were 0.2 ${\mu}g/mL$ and 0.5 ${\mu}g/mL$, respectively. The intra- and inter-day precision of schizandrin calibration standards was 0.06~0.66% and 0.13~1.19%, respectively, and the intra- and inter-day accuracy of schizandrin was 98.35~103.30% and 98.35~103.00%, respectively. Overall, schizandrin was validated through our analytical methods as a marker compound in Jangsu Omija.

Profiling Stress History(OCR, $\sigma를$p) of Marine Clay Using Piezocone Penetration Test (해성점토지반에서 CPT를 이용한 응력이력(OCR, $\sigma$를 p)의 산정)

  • 이강운;윤길림;채영수
    • Journal of the Korean Geotechnical Society
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    • v.18 no.6
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    • pp.73-81
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    • 2002
  • Various CPT-based prediction models far profiling stress history of marine clay at the southern part of the Korean peninsula were investigated by using both statistical analysis and case history study. Preconsolidation pressures($\sigma'$p) and overconsolidation ratio(OCR) estimated by empirical correlations and cone penetration tests were compared with those of laboratory odometer test results. Stress history of marine clay determined by odometer test results was in general overconsolidated at below 10m depth from the mudline, whereas marine clay at below l0m depth from the mudline which has an around 0.3 overconsolidation ratio showed variable stresses and unstable states. Preconsolidation pressures were computed by both empirical methods of the Chen and Mayne(1996) and theoretical method of Konrad and Law(1987). It is estimated that Chen and Mayne(1996)'s prediction method based on pore water pressure is more reliable than any other prediction methods, and their method proved to be the most reliable for overconsolidation ratio estimation. However, it is recommended that Mayne & Holtz(1988) and Mayne & Bachus(1988) methods are more suitable than any other methods for predicting the overconsolidation ratio at an underconsolidated (OCR<1) clay. For these reasons, rather than making use of existing prediction models, development of site specific empirical correlations which considers local characteristics and site conditions may be required due to different local stress history and variable soil properties.

Development of high performance liquid chromatography assay method of diosmin capsules (디오스민 캡슐의 HPLC 분석법의 개발)

  • Shim, Dae Hyun;Shin, Dong Han;Truong, Quoc Ky;Mai, Xuan Lan;Kang, Jong-Seong;Woo, Mi Hee;Na, Dong-Hee;Chun, In-Koo;Kim, Kyeong Ho
    • Analytical Science and Technology
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    • v.29 no.6
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    • pp.277-282
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    • 2016
  • British Pharmacopoeia (BP 2013), the United States Pharmacopoeia (USP 39) and the Korean Pharmacopoeia (KP XI) contain monographs for the quality control of raw diosmin using high performance liquid chromatography (HPLC). However, official monographs detailing pharmaceutical formulations for diosmin are not available in foreign pharmacopoeias. In the KP XI, ultraviolet-visible (UV-Vis) spectroscopy-which is less specific than HPLC-is reported for the testing of diosmin capsules. In this study, we present an alternative HPLC assay for such testing that is more specific than UV-Vis methods. Method validation was performed to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of calibration curves in the desired concentration range was high ($r^2$>0.999), while the RSDs for intra- and inter-day precision were 0.15-0.29 % and 1.05-1.74%, respectively. Accuracies ranged from 101.2-103.2 %, while the retention time and peak area RSDs were 0.37 % and 0.06 %, respectively. Additionally, the plate number and asymmetry factor values for diosmin were 3591.293 and 1.35, respectively. Since the intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).

Formal Description and Reference Implementation Code Generation for a Security Algorithm using VDM-SL (VDM-SL을 이용한 보안 알고리즘의 형식적 표현과 참조구현 코드 생성)

  • Kim, Young-Gil;Kim, Ki-Su;Kim, Young-Wha;Ryou, Jae-Cheol;Jang, Chung-Ryong
    • Journal of the Korea Institute of Information Security & Cryptology
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    • v.6 no.4
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    • pp.67-84
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    • 1996
  • VDL-SL (Vienna Development Method-Specification Language) is one of the FSL(Formal Specification Language) which is being presented for the correct description of the security relevant standards. Several tools are being developed for the correctness and the convenience in the description and executable code generation of security relevant standards using VDM-SL. The IFAD VDM-SL Toolbox is one that has many functions : syntax checking, type checking, c++ code generation, test coverage information. This paper describes a formal method for description and implementation of MD4 algorithm using VDM-SL and IFAD VDM-SL Toolbox, and examines the result applied to secure hash algorithm, and proposes the relation to strict conformance test which recently suggested as a security test method.