• Title/Summary/Keyword: standard reference materials

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Characterizing a full spectrum of physico-chemical properties of (20S)-and (20R)-ginsenoside Rg3 to be proposed as standard reference materials

  • Kim, Il-Woung;Sun, Won Suk;Yun, Bong-Sik;Kim, Na-Ri;Min, Dongsun;Kim, Si-Kwan
    • Journal of Ginseng Research
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    • v.37 no.1
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    • pp.124-134
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    • 2013
  • The authentication of the physico-chemical properties of ginsenosides reference materials as well as qualitative and quantitative batch analytical data based on validated analytical procedures is a prerequisite for certifying good manufacturing practice (GMP). Ginsenoside Rb1 and Rg1, representing protopanaxadiol and protopanaxatriol ginsenosides, respectively, are accepted as marker substances in quality control standards worldwide. However, the current analytical methods for these two compounds recommended by Korean, Chinese, European, and Japanese pharmacopoeia do not apply to red ginseng preparations, particularly the extract, because of the relatively low content of the two agents in red ginseng compared to white ginseng. In manufacturing fresh ginseng into red ginseng products, ginseng roots are exposed to a high temperature for many hours, and the naturally occurring ginsenoside Rb1 and Rg1 are converted to artifact ginsenosides such as Rg3, Rg5, Rh1, and Rh2 during the heating process. The analysis of ginsenosides in commercially available ginseng products in Korea led us to propose the inclusion of the (20S)- and (20R)-ginsenoside Rg3, including ginsenoside Rb1 and Rg1, as additional reference materials for ginseng preparations. (20S)- and (20R)-ginsenoside Rg3 were isolated by Diaion HP-20 adsorption chromatography, silica gel flash chromatography, recrystallization, and preparative HPLC. HPLC fractions corresponding to those two ginsenosides were recrystallized in appropriate solvents for the analysis of physico-chemical properties. Documentation of those isolated ginsenosides was achieved according to the method proposed by Gaedcke and Steinhoff. The ginsenosides were subjected to analyses of their general characteristics, identification, purity, content quantification, and mass balance tests. The isolated ginsenosides showed 100% purity when determined by the three HPLC systems. Also, the water content was found to be 0.534% for (20S)-Rg3 and 0.920% for (20R)-Rg3, meaning that the net mass balances for (20S)-Rg3 and (20R)-Rg3 were 99.466% and 99.080%, respectively. From these results, we could assess and propose a full spectrum of physico-chemical properties of (20S)- and (20R)-ginsenoside Rg3 as standard reference materials for GMP-based quality control.

Use of preoperative cone-beam computed tomography to aid in establishment of endodontic working length: A systematic review and meta-analysis

  • Paterson, Andrew;Franco, Vittorio;Patel, Shanon;Foschi, Federico
    • Imaging Science in Dentistry
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    • v.50 no.3
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    • pp.183-192
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    • 2020
  • Purpose: This study was performed to assess the accuracy of preoperative cone-beam computed tomography (CBCT), when justified for other reasons, in locating the apical foramen and establishing the working length. Materials and Methods: Six electronic databases were searched for studies on this subject. All studies, of any type, were included if they compared measurements of working length with preoperative CBCT to measurements using an electronic apex locator (EAL) or histological reference standard. Due to the high levels of heterogeneity, an inverse-variance random-effects model was chosen, and weighted mean differences were obtained with 95% confidence intervals and P values. Results: Nine studies were included. Compared to a histological reference standard, CBCT indicated that the apical foramen was on average 0.40 mm coronal of its histological position, with a mean absolute difference of 0.48 mm. Comparisons were also performed to an EAL reference standard, but the conclusions could not be considered robust due to high levels of heterogeneity in the results. Conclusion: A low level of evidence is produced suggesting that preoperative CBCT shows the apical foramen to be on average 0.40 mm coronal to its histological position, with a mean absolute difference of 0.48 mm.

Investigation of occurrence factors on brucellosis-outbreak farm in Korea (소 브루셀라병 동시 다두 발생 농장의 발생 요인 조사)

  • Kim, Ji-Yeon;Kang, Shin-Seok;Her, Moon;Lee, Kichan;Sung, So-Ra;Gu, Jung-Hui;Kang, Sung-Il;Lee, Hyang-Keun;Kim, Yu-Jin;Kim, Dong-Gil;Jung, Suk-Chan
    • Korean Journal of Veterinary Service
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    • v.35 no.4
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    • pp.263-268
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    • 2012
  • From the end of July 2012, several cases of abortion have been happened at the Korean indigenous cattle farm with 124 heads in Chungbuk province, Korea. Serological tests such as Rose-bengal test (RBT) and standard tube agglutination test (STAT) have been performed according to the standard official protocols of bovine brucellosis and 41 cattle turned out to be brucellosis-positive simultaneously. To find out the main factors of brucellosis outbreaks and spreads, additional serological, etiological and molecular investigation were applied. Totally, 11 B. abortus were isolated from 10 cattle's specimens including lymph-nodes and/or testis, and drinking water in cowhouse. In genotyping by multi-locus VNTR assay (MLVA) using 17 loci markers, the present B. abortus isolates were shown all the same pattern, D1 genotype, which has been reported in Gyeonggi and Gangwon province, Korea. These results suggest that the input of brucellosis might come from neighboring farms directly or indirectly, even if by unknown factor and expansion within farm would accelerate by materials related with aborting cows.

Analysis of 11-nor-9-carboxy-Δ9-tetrahydrocannabinol in urine with certified reference material (인증표준물질(CRM)을 이용한 소변 중 대마 대사체 분석법 평가)

  • Ko, Beom-Jun;Kim, Jin-Young;Kim, Jong-Sang;Lee, Jeong-Jik;Cheong, Jae-Chul;Suh, Sung-Ill;In, Moon-Kyo
    • Analytical Science and Technology
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    • v.23 no.1
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    • pp.83-88
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    • 2010
  • For the evaluation of our laboratory's 11-nor-${\Delta}^9$-tetrahydrocannabinol-9-carboxylic acid (THCCOOH) urinalysis test, THCCOOH urinalysis test was carried out with Certified Reference Material (CRM). The used CRM was THCCOOH in freeze-dried urine produced by NIST as Standard Reference Material 1507b. Comparing the estimated value of our laboratory with CRM, the results was coincided in the confidence level of approximately 95%.

Development of Certified Reference Materials for Analysis of Heavy Metals in Paints to Cope with Environmental Regulations (환경규제 대응을 위한 페인트 중의 중금속 분석용 인증 표준물질 개발)

  • Yu, Byung Kyu;Sun, Yle Shik
    • Journal of Environmental Analysis, Health and Toxicology
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    • v.21 no.4
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    • pp.209-219
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    • 2018
  • In the areas of RoHS, WEEE, ELV and REACH, reinforcement of environmental regulations against harmful substances is a global trend not only in EC but also in all over the world. In the fields of Korea's major export products such as material parts, electrical and electronic products and automobile parts, we are responding to these regulations consistently. To develop reference material for analyzing lead and cadmium in paints, the candidate materials were produced through the screening process which separated shapes and sizes. To secure the traceability of the candidate materials produced, the characteristics and uncertainties are estimated by ICP-AES analysis using the primary reference material. The short-term and long-term stabilities also are evaluated in parallel. In order to calculate the final certification value of the candidate material, the verification were carried out by the performance evaluation through the comparison among the KOLAS (Korea Laboratory Accreditation Scheme) laboratories, and the CRM was produced in accordance with ISO Guide 35. The certified values and uncertainties of Pb and Cd of the final paint standard, determined according to the joint analysis among laboratories, are Pb [($191.4{\pm}3.1$) mg/kg, ($944.1{\pm}5.6$) mg/kg] and Cd [($45.0{\pm}2.6$) mg/kg, ($225.5{\pm}3.5$) mg/kg]. These standard materials were developed to enhance the reliability of measurement analysis, including the validity and traceability of measurement results. Also it is expected that the CRM will be used as QCM (quality control material) for the product design and the process monitoring, so that regulation and management of hazardous heavy metals can be systematically implemented.

The Thermal Performance of Building Insulation Materials According to Long-Term Aging (건축용 단열재의 장기 경시변화에 따른 열성능 특성)

  • Choi, Bo-Hye;Kang, Jae-Sik
    • Korean Journal of Air-Conditioning and Refrigeration Engineering
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    • v.25 no.11
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    • pp.617-623
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    • 2013
  • This study is to draw thermal property data during long-term aging, by testing the thermal conductivity of building insulation materials in Korea. The thermal resistance of extruded insulation within 3 days from manufacture performed well over the KS Standard. After 50 to 110 days, however, the thermal performance had deteriorated to the level of the KS standard. Eventually, after 4,000 days, the insulation performance had deteriorated to about 25.4~41.8% of the initial performance. Therefore, this research will be utilized as a reference for thermal properties during long-term aging, in order to improve standards and regulations related to building insulation materials.

Development of nitrogen and oxygen certified reference materials in 10 μmol/mol for the purity evaluation

  • Ahn, Byung Soo;Moon, Dong Min;Lee, Jin Bok;Kim, Jin Seog;Lee, Jin-Hong;Hong, Kiryong
    • Analytical Science and Technology
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    • v.33 no.2
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    • pp.68-75
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    • 2020
  • We have developed 10 μmol/mol nitrogen and oxygen certified reference materials (CRMs) in helium, as a SI-traceable gas standard for a quantifying of impurities in pure gases for the first time in Korea. The standard gas mixtures of nitrogen and oxygen were prepared in 5000 μmol/mol and sequentially were diluted to 250 μmol/mol and 10 μmol/mol according to the gravimetric preparation. In each dilution step, two cylinders of CRMs were prepared. The verification of internal consistency among the prepared gas mixtures was performed by using GC-TCD. The amount fractions and those expanded uncertainties (k = 2) of nitrogen and oxygen in the standard gas mixtures were (10.12 ± 0.08) μmol/mol and (10.18 ± 0.08) μmol/mol for nitrogen, and (9.88 ± 0.06) μmol/mol and (9.94 ± 0.06) μmol/mol for oxygen, respectively. We have conducted a purity assessment of two commercial helium gases using developed CRMs. As the results of the purity assessment, nitrogen and oxygen were detected by (1.66 ± 0.03) μmol/mol and (0.31 ± 0.02) μmol/mol, respectively, as the impurities in one of the pure helium.

Result Analysis according to Population Distribution Trends when Reagents are Changed (시약 변경 시 모집단 분포 추이에 따른 결과 분석)

  • Hye-Mi Park;Soo-Yeon Lim;Sun-Hee Yoo;Sun-Ho Lee
    • The Korean Journal of Nuclear Medicine Technology
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    • v.27 no.1
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    • pp.55-61
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    • 2023
  • Purpose In this study, the monthly population distribution was calculated for statistical verification of 10 tests (CA19-9, CA15-3, testosterone, PTH, calcitonin, AFP, CEA, CA72-4, PSA, estradiol) with changed reagents, and the trend of change By comparing and analyzing the results, we want to verify the accuracy of the results and improve the reliability of the test. Materials and Methods From June 2021 to February 2023, for the 10 items in which the reagent was changed, the monthly percentage and standard deviation index before and after the reagent change were compared, respectively. At this time, the reference value was arbitrarily set for the comparison group in consideration of the reference value of the test item, and the groups were subdivided and compared, and the standard deviation index allowed range was -2.0 or more and 2.0 or less. Results For CA19-9, CA15-3, AFP, CEA, and calcitonin 5 test items, the change in monthly ratio in all test sections before and after the reagent change was kept constant. On the other hand, for CA72-4, PSA, testosterone, PTH, and estradiol items, the standard deviation index exceeded the acceptable standard after changing the reagent. CA72-4 test items showed an increasing trend in standard deviation index in the test section exceeding the reference value. In the case of the PSA test item, the maintenance ratio of 0.04 ng/mL was significantly decreased after changing the reagent. The testosterone test item had a standard deviation index of -2.5 in the test section exceeding 10.1 ng/mL after changing the reagent, and the standard deviation index of the PTH test item was out of the acceptable range in all test sections. It was confirmed that the estradiol test item showed an overall increase in the result value. Conclusion Through this study, the continuity and accuracy of the test results could be verified. It is considered that the stability of the test can be secured by analyzing the factors affecting the test result and solving the cause for the test item whose standard deviation index is out of the acceptable standard.

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Construction of an ISO 15926-based Reference Data Server Using iRINGTools and Its Application (iRINGTools를 활용한 ISO 15926 기반 기자재 참조 데이터 서버의 구축과 활용)

  • Kim, Bongcheol;Park, Sangjin;Kwon, Soonjo;Byon, Su-jin;Mun, Duhwan;Han, Soonhung
    • Korean Journal of Computational Design and Engineering
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    • v.22 no.2
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    • pp.150-161
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    • 2017
  • Effective data exchange among the diverse stakeholders participating in a process plant project is an important issue. ISO 15926 is an international standard to support sharing and integrating of process plant data. iRINGTools is an ISO 15926-based tool used to exchange plant data. To exchange plant data using iRINGTools, the mapping between the data model of a commercial system and ISO 15926 should be preceded. To accomplish this, types and properties of equipment and materials used for plant design should be predefined and these data should be represented as user-defined reference data complying with ISO 15926. Besides, the user-defined reference data should be serviced by a reference data server such that iRINGTools searches reference data from the server and utilizes the data for the model mapping. In this paper, we present a method to construct a reference data server and use it for the model mapping in iRINGTools. The proposed method is verified through experiments of exchanging specifications data of equipment and materials using iRINGTools.

A Study on the Evaluation of Long Term Stability of Brinell Standard Hardness Tester and Automatic Indentation Measurement System and Optimum Test Condition (브리넬 경도 표준 시험기 및 압입자국 자동 측정 장치의 장기 안정도 평가와 최적 시험조건에 관한 연구)

  • Bahng, G.W.;Tak, Nae-Hyung;Hwang, N.M.
    • Journal of the Korean Society for Heat Treatment
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    • v.13 no.1
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    • pp.10-15
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    • 2000
  • Evaluation of long term stability of the Brinell standard hardness tester was carried out to secure its application as a national standard in Brinell hardness. Accuracy and repeatability in load application were tested through evaluating errors in hardness measurement of certified reference blocks. All of those requirements in KS as well as ISO specifications were satisfied by this standard hardness tester. In addition to this, long term stability test of automatic indentation measurement system was carried out. The scattering range was almost the same with its error range. To figure out an optimum test condition for better repeatability and long term stability, the effect of load variation, load application speed and time have been studied using orthogonal array experimental plan. It was found that the best combination is $30{\mu}m/s$ of load application speed and 25 seconds of load application time.

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