• Title/Summary/Keyword: Stability Limit

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Qualitative and quantitative assessment of process related impurities in Brigatinib raw material and formulations using HPLC

  • Attada Tharun;Potnuru Jagadeesh;B Srinivasa Kumar;Kota Thirumala Prasad;Venkateswara Rao Anna
    • 분석과학
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    • 제36권4호
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    • pp.180-190
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    • 2023
  • The presence of process related impurities in any drug or the drug product was associated with its safety, stability and efficacy. The overall literature survey proved that there is no method published on the assessment of process related impurities in brigatinib. In this study, a simple, reliable and stable HPLC qualitative method was reported for quantification of process related impurities with easy and quick extraction procedure. The impurities along with standard brigatinib was resolved on Lichrospher® C18 (250 mm × 4.6 mm; 5 ㎛ particle size) column in room temperature using methanol, acetonitrile, pH 4.5 phosphate buffer in 55:25:20 (v/v) at 1.0 mL/min as mobile phase and UV detection at 261 nm. The method produces well resolved peaks at retention time of 4.60 min, 12.28 min, 3.37 min, 7.34 min and 8.39 min respectively for brigatinib, impurity A, B, C and D. The method produces a very sensitive detection limit of 0.0065 ㎍/mL, 0.0068 ㎍/mL, 0.0053 ㎍/mL and 0.0058 ㎍/mL for impurity A, B, C and D respectively with calibration curve linear in the concentration range of 22.5-135 ㎍/mL for brigatinib and 0.0225-0.135 ㎍/mL for impurities. The method produces all the validation parameters under the acceptable level and doesn't produces any considerable changes in peak area response while minor changes in the developed method conditions. The method can effectively resolve the unknown stress degradation products along with known impurities with less % degradation. The method can efficiently resolve and quantify the impurities in formulation and hence can suitable for the routine quality analysis of brigatinib in raw material and formulation.

고기능성 세라믹 주형 및 중자 제작을 위한 3원계 무기 바인더 시스템 개발 (Development of Ternary Inorganic Binder System for Manufacturing High-Functional Ceramic Molds and Core)

  • 박혜영;조근호;최현희;김봉구;김은희;양승철;정연길
    • 한국재료학회지
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    • 제32권12호
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    • pp.538-544
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    • 2022
  • In existing ceramic mold manufacturing processes, inorganic binder systems (Si-Na, two-component system) are applied to ensure the effective firing strength of the ceramic mold and core. These inorganic binder systems makes it possible to manufacture a ceramic mold and core with high dimensional stability and effective strength. However, as in general sand casting processes, when molten metal is injected at room temperature, there is a limit to the production of thin or complex castings due to reduced fluidity caused by the rapid cooling of the molten metal. In addition, because sodium silicate generated through the vitrification reaction of the inorganic binder is converted into a liquid phase at a temperature of 1,000 ℃. or higher, it is somewhat difficult to manufacture parts through high-temperature casting. Therefore, in this study, a high-strength ceramic mold and core test piece with effective strength at high temperature was produced by applying a Si-Na-Ti three-component inorganic binder. The starting particles were coated with binary and ternary inorganic binders and mixed with an organic binder to prepare a molded body, and then heat-treated at 1,000/1,350/1,500 ℃ to prepare a fired body. In the sample where the two-component inorganic binder was applied, the glass was liquefied at a temperature of 1,000 ℃ or higher, and the strength decreased. However, the firing strength of the ceramic mold sample containing the three-component inorganic binder was improved, and it was confirmed that it was possible to manufacture a ceramic mold and core via high temperature casting.

수열 합성법에 의해 제조된 주석-안티몬 황화물계 나노복합체 기반 나트륨이온전지용 음극의 전기화학적 특성 (Electrochemical Properties of Tin-Antimony Sulfide Nanocomposites Synthesized by Hydrothermal Method as Anode Materials for Sodium Ion Batteries)

  • 박소현;정수환;엄수윤;이상준;김주형
    • 한국재료학회지
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    • 제32권12호
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    • pp.545-552
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    • 2022
  • Tin-antimony sulfide nanocomposites were prepared via hydrothermal synthesis and a N2 reduction process for use as a negative electrode in a sodium ion battery. The electrochemical energy storage performance of the battery was analyzed according to the tin-antimony composition. The optimized sulfides exhibited superior charge/discharge capacity (770 mAh g-1 at a current density of 100 mA g-1) and stable lifespan characteristics (71.2 % after 200 cycles at a current density of 500 mA g-1). It exhibited a reversible characteristic, continuously participating in the charge-discharge process. The improved electrochemical energy storage performance and cycle stability was attributed to the small particle size, by controlling the composition of the tin-antimony sulfide. By optimizing the tin-antimony ratio during the synthesis process, it did not deviate from the solubility limit. Graphene oxide also acts to suppress volume expansion during reversible electrochemical reaction. Based on these results, tin-antimony sulfide is considered a promising anode material for a sodium ion battery used as a medium-to-large energy storage source.

시스템 모델을 통한 PLC 기반 시스템의 RTOS 기반 시스템으로의 변환 (System Model-driven Conversion from PLC-based Systems to RTOS-based Systems)

  • 김제웅;임성수
    • 한국컴퓨터정보학회논문지
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    • 제14권3호
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    • pp.13-26
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    • 2009
  • 본 논문에서는 현재 많은 산업 현장에서 자동 제어를 위한 시스템으로 사용하는 PLC를 대체하기 위한 시스템으로 RTOS 기반 시스템을 제안하였다. RTOS 기반 시스템은 PLC의 한계를 극복하고 시스템의 안정성곽 신뢰성을 보장하기 위한 방법으로 PC와 RTOS를 사용하는 시스템이다. 그리고 PLC 기반 시스템을 RTOS 기반 시스템으로 변환하기 위한 방법으로 시스템 모델을 통한 변환 방법을 제안하였고 변환 절차와 변환 방법을 설명하였다. 시스템 모델은 PLC 기반 시스템을 RTOS 기반 시스템으로 변환하기에 앞서 시스템을 상위 레벨에서 하위레벨로 태스크 단위로 분석한 것으로 시스템을 모듈 별로 정의하고 정의된 모듈의 동작을 태스크로 세분화하여 정의한 것이다. 모듈 별로 시스템을 제어하는 것은 PLC를 통한 제어에 비해 성능뿐만 아니라 기능적으로도 향상을 가져오고 추후 시스템의 수정이나 변화 시에도 더 유연하게 대처할 수 있다.

극직교 이방성 회전원판의 진동에 대한 횡전단변형 및 회전관성 효과 (Effects of Transverse Shear Deformation and Rotary Inertia on Vibration of Rotating Polar Orthotropic Disks)

  • 김동현;구교남
    • Composites Research
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    • 제20권3호
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    • pp.43-49
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    • 2007
  • 회전원판의 동적 불안정성은 회전속도를 제한하는 가장 중요한 요인이다. 복합재료를 회전원판에 적용시킬 경우 동적 안정성을 증가시킬 수 있어 경량화와 고속화를 동시에 이룰 수 있다. 티모쉔코 효과라고 불리는 횡전단변형과 회전관성이 판 구조물의 동적거동에 미치는 영향은 많은 연구가 진행되어왔으나 원판의 회전이 이 효과에 미치는 영향에 대한 연구는 극히 제한적이며 복합재료 원판의 경우는 전무한 실정이다. 본 연구에서는 티모쉔코 효과를 고려한 직교이방성 회전원판의 동적 방정식을 유도하였으며 상용 유한요소 프로그램인 MSC/NASTRAN을 이용하여 진동해석을 수행하였다. 해석결과에 따르면 특정 모드에서는 일반적으로 알려진 바와는 달리 회전수의 증가에 따라 티모쉔코 효과가 감소하다 증가하는 현상을 보였다. 또한 데이터만을 기초로 회전증가에 따른 티모쉔코 효과의 감소는 두께비가 작아질수록 증가하고, 반경비, 탄성계수 대 전단계수 비, 진동 모드 수가 커질수록 증가하는 것으로 결론지을 수 있다.

Remote digital monitoring during the retention phase of orthodontic treatment: A prospective feasibility study

  • Sangalli, Linda;Savoldi, Fabio;Dalessandri, Domenico;Visconti, Luca;Massetti, Francesca;Bonetti, Stefano
    • 대한치과교정학회지
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    • 제52권2호
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    • pp.123-130
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    • 2022
  • Objective: To evaluate if a remote digital monitoring system added at the end of orthodontic treatment could positively influence the retention phase by reducing the occurrence of misfit of removable appliances, number of emergency appointments (EA), and orthodontic relapse. Methods: Twenty-seven patients who completed active orthodontic treatment were divided into the study and control groups. In addition to the standard chairside follow-up appointments at month 1 (T1), month 3 (T2), month 6 (T3), the study group patients were monitored using Dental Monitoring® with monthly intra-oral scans. Occurrence of misfit of removable retainers, number of EAs, and intercanine width change were recorded for both groups. Differences in EAs and retainer fit were assessed using the chi-square test. Intra-group and inter-group differences in the intercanine width were assessed with Friedman test and Mann-Whitney U test, respectively (α = 0.05). Results: The study group showed a significantly lower occurrence of misfit of removable retainers (p = 0.027) compared to the control group. No significant inter- and intra-group difference was found in the EAs and intercanine width change at each time-point. Conclusions: Integrating remote monitoring systems, such as Dental Monitoring®, to the retention phase of the orthodontic treatment may lower the occurrence of misfit of removable retainers. However, a small sample size and a short observation period limit the strength of this evidence. These preliminary results tentatively suggest that remote monitoring technologies may be beneficial, especially during the COVID-19 pandemic, when the regularity of in-office visits might be disrupted.

머신러닝 기반 가치투자를 통한 주식 종목 선정 연구: 내재가치를 중심으로 (Selecting Stock by Value Investing based on Machine Learning: Focusing on Intrinsic Value)

  • 김윤승;유동희
    • 한국정보시스템학회지:정보시스템연구
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    • 제32권1호
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    • pp.179-199
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    • 2023
  • Purpose This study builds a prediction model to find stocks that can reach intrinsic value among KOSPI and KOSDAQ-listed companies to improve the stability and profitability of the stock investment. And investment simulations are conducted to verify whether stock investment performance is improved by comparing the prediction model, random stock selection, and the market indexes. Design/methodology/approach Value investment theory and machine learning techniques are applied to build the model. Various experiments find conditions such as the algorithm with the best predictive performance, learning period, and intrinsic value-reaching period. This study selects stocks through the prediction model learned with inventive variables, does not limit the holding period after buying to reach the intrinsic value of the stocks, and targets all KOSPI and KOSDAQ companies. The stock and financial data are collected for 21 years (2001-2021). Findings As a result of the experiment, using the random forest technique, the prediction model's performance was the best with one year of learning period and within one year of the intrinsic value reaching period. As a result of the investment simulation, the cumulative return of the prediction model was up to 1.68 times higher than the random stock selection and 17 times higher than the KOSPI index. The usefulness of the prediction model was confirmed in that the number of intrinsic values reaching the predicted stock was up to 70% higher than the random selection.

무릎 각도의 차이에 따른 불안정 지지면에서의 스쿼트훈련이 건강한 성인의 균형 능력에 미치는 영향 (The Effect of Squat Training on an Unstable Support Surface According to the Angle Different Knee Flexion Angles on Healthy Adult's Balance Ability)

  • 유병호;홍현표;최태석
    • 대한정형도수물리치료학회지
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    • 제29권3호
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    • pp.1-11
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    • 2023
  • Background: The aim of this study was to compare the effects of squat training on an unstable support surface with different knee flexion angles on the balance ability of normal adults balance ability. Methods: 41 university students in their 20s attending N University in Cheonan, Chungcheongnam-do were divided into a 45-degree knee-bending squat training group and a 90-degree knee-bending squat training group. The groups trained on an unstable support surface 20 minutes per day, 3 times a week, for a total of 4 weeks. Results: Changes in static balance ability were not significant within and between the groups for both the sway distance and sway area in the eyes open and eyes closed states (p<.05). The changes in dynamic balance ability were significant in the forward, leftward, and rightward angles in both groups at the limit of stability (p<.05), but not significant in the backward angle (p>.05), and the comparison between groups was not significant (p>.05). Conclusion: No significant difference between static balance-related variables within and between the groups was found. Significant changes in dynamic balance-related variables within the groups were found but not between the groups. Therefore, in future studies, it is considered necessary to study various ages and differentiated intervention periods, such as young adults and the population of elderly people, with sufficient intervention periods to affect balance ability.

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Optimum position for outriggers of different materials in a high- rise building

  • Nikhil Y. Mithbhakare;Popat D. Kumbhar
    • Earthquakes and Structures
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    • 제25권5호
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    • pp.359-367
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    • 2023
  • High-rise structures are considered as symbols of economic power and leadership. Developing countries like India are also emerging as centers for new high-rise buildings (HRB). As the land is expensive and scarce everywhere, construction of tall buildings becomes the best solution to resolve the problem. But, as building's height increases, its stiffness reduces making it more susceptible to vibrations due to wind and earthquake forces. Several systems are available to control vibrations or deflections; however, outrigger systems are considered to be the most effective systems in improving lateral stiffness and overall stability of HRB. In this paper, a 42-storey RCC HRB is analyzed to determine the optimum position of outriggers of different materials. The linear static analysis of the building is performed with and without the provision of virtual outriggers of reinforced cement concrete (RCC) and pre-stressed concrete (PSC) at different storey levels by response spectrum method using finite element based Extended3D Analysis of building System (ETABS) software for determining responses viz. storey displacement, base shear and storey drift for individual models. The maximum allowable limit and percentage variations in earthquake responses are verified using the guidelines of Indian seismic codes. Results indicate that the outriggers contribute in significantly reducing the storey displacement and storey drift up to 28% and 20% respectively. Also, it is observed that the PSC outriggers are found to be more efficient over RCC outriggers. The optimum location of both types of outriggers is found to be at the mid height of building.

Characterization of degradation products of the Balsalazide by Mass spectrometry: Optimization of stability-indicating HPLC method for separation and quantification of process related impurities of Balsalazide

  • Chilakabattina Naga Narasimha Babu;Ch. Srinivasa Reddy;Bhagya Kumar Tatavarti;M. Radha Madhavi;Venkateswara Rao Anna
    • 분석과학
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    • 제37권1호
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    • pp.25-38
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    • 2024
  • The study aimed to investigate a novel approach by utilizing liquid chromatography (LC) and liquid chromatography-mass spectrometry (LC-MS) to separate, identify and characterize very nominal quantities of degradation products (DPs) of balsalazide along with its process related impurities without isolation from their reaction mixtures. The impurities along with balsalazide were resolved on spherisorb ODS2 (250×4.6 mm, 5.0 ㎛) column at room temperature using 0.2 M sodium acetate solution at pH 4.5 and methanol in the ratio of 55:45 (v/v) as mobile phase pumped isocratically at 1.0 mL/min as mobile phase and UV detection at 255 nm. The method shows sensitive detection limit of 0.003 ㎍/mL, 0.015 ㎍/mL and 0.009 ㎍/mL respectively for impurity 1, 2 and 3 with calibration curve liner in the range of 50-300 ㎍/mL for balsalazide and 0.05-0.30 for its impurities. The balsalazide pure compound was subjected to stress studies and a total of four degradation products (DPs) were formed during the stress study and all the DPs were characterized with the help of their fragmentation pattern and the masses obtained upon LC-MS/MS. The DPs were identified as 3-({4-[(E)-(4-hydroxyphenyl) diazenyl]benzoyl}amino)propanoic acid (DP 1), 4-[(E)-(4-hydroxyphenyl)diazenyl] benzamide (DP 2), 5-[(E)-(4-carbamoylphenyl)diazenyl]-2-hydroxybenzoic acid (DP 3) and 3-({4-[(E)-phenyldiazenyl]benzoyl}amino)propanoic acid (DP 4). Based on findings, it was concluded that, the proposed method was successfully applicable for routine analysis of balsalazide and its process related impurities in pure drug and formulations and also applicable for identification of known and unknown impurities of balsalazide.