• Title/Summary/Keyword: Safety critical separation

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Establishing and validating an HPLC protocol for pralsetinib impurities analysis, coupled with HPLC-MS/MS identification of stress degradation products

  • Rajesh Varma Bhupatiraju;Pavani Peddi;Venkata Swamy Tangeti;Battula Sreenivasa Rao
    • Analytical Science and Technology
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    • v.37 no.5
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    • pp.280-294
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    • 2024
  • This study introduces a novel analytical method for the assessment of pralsetinib impurities and degradation products (DPs), addressing critical gaps in existing methodologies. This research aims to develop a robust HPLC method for impurity analysis, characterize degradation products using LC-MS, and evaluate the environmental impact of the method. The study began by optimizing HPLC conditions with various columns and buffers, ultimately achieving successful separation using an XBridge® RP-C18 column with ethanol as solvent A and 50 mM formic acid at pH 2.9. This setup provided excellent peak resolution and symmetry, essential for reliable stability studies. The developed HPLC method was then adapted for HPLC-MS/MS, enhancing sensitivity and detection efficiency of DPs. Stress degradation studies of pralsetinib under different conditions (acidic, basic, oxidative, thermal, and photolytic) revealed significant degradation under acidic (29.3 %) and basic (21.5 %) conditions, with several DPs identified. Oxidative stress resulted in 19.8 % degradation, while thermal and photolytic conditions caused minimal degradation. HPLC-MS/MS analysis identified structures of five degradation products, providing detailed insights into pralsetinib's stability and degradation pathways. Method validation followed ICH guidelines Q2(R1), confirming method's specificity, selectivity, sensitivity, linearity, accuracy, precision, and robustness. The method exhibited strong linearity with a coefficient of determination (r2) greater than 0.999 for pralsetinib and its impurities. This method advances impurity detection and DPs characterization, ensuring the quality and safety of pralsetinib. Additionally, method's environmental impact was assessed, aligning with sustainable analytical practices. These findings provide essential data on pralsetinib's stability, guiding storage conditions and ensuring its efficacy and safety in pharmaceutical applications.

Analytical Study on Interface Debonding of Reinforced Concrete Beams Strengthened with Carbon Fiber Sheet(CFS) (탄소섬유쉬트로 보강된 철근콘크리트보의 계면박리에 대한 해석적 연구)

  • Sim, Jong-Sung;Bae, In-Hwan
    • Magazine of the Korea Concrete Institute
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    • v.11 no.2
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    • pp.177-186
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    • 1999
  • The purpose of this study is to analyze the interface debonding of RC beams strengthened by carbon fiber sheet(CFS). The behavior of damaged RC beams strengthened with CFS is analytically investigated next using linear elastic fracture mechanics(LEFM) approach and the finite element method. The study includes an investigation of the separation mode by interface fracture of the strengthening materials due to the interfacial shear and normal stresses. The numerical method is presented to obtain the value of interfacial fracture parameter such as the strain energy release rate. Based on the results of this study, it is found that the critical case occurs when the interfacial cracks occur within a short region of the flexural crack. The CFS strengthening has not an adequate factor of safety against interfacial debonding of CFS. Furthermore, for the thicknesses of the adhesive studied[1mm~3mm], it is no noticeable effect on the strain energy release rate.

Study on Antecedent Moisture Condition for Seolma Stream Basin

  • Ly, Sidoeun;Shin, Hyun Seok;Kim, Duck Hwan;Kim, Beom Jun;Kim, Hung Soo
    • Journal of Wetlands Research
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    • v.15 no.4
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    • pp.609-618
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    • 2013
  • Curve number (CN), originally developed, compiled by 'The Natural Resources Conservation Service (NRCS)', and has been widely used throughout the world. However, there is the uncertainty of CN derived from the use of antecedent moisture condition (AMC)/Antecedent Runoff Condition (ARC). As in Korea where nearly 70% covered by mountainous area, it is still not sufficient handbook precedent to guide or support the estimation of AMC/ARC. The failure to develop formal criteria of applying AMC/ ARC will be a gaping profession and results not only in uncertainty of CN estimation in particular, but also in designing appropriate structures in Korea as a whole. This paper is aiming at presenting a critical review of AMC/ARC and deriving a procedure to deal more realistically with event rainfall-runoff over wider variety of initial conditions. Proposed methods have been developed. It is based on modifying estimated runoff to observed runoff with coefficient of determination and then applying different algebraic expression with the verification of AMC by antecedent rainfall table of NEH-1964. The result shows that algebraic expression by Arnold et al. (1996) is the most appropriate for AMC/ARC and the results of AMC/ARC estimation criteria are generally very close to each other. Therefore, this algebraic expression might be applied in South Korea condition properly.

Implementation and Performance Analysis of Partition-based Secure Real-Time Operating System (파티션 기반 보안 실시간 운영체제의 구현 및 성능 분석)

  • Kyungdeok Seo;Woojin Lee;Byeongmin Chae;Hoonkyu Kim;Sanghoon Lee
    • Convergence Security Journal
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    • v.22 no.1
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    • pp.99-111
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    • 2022
  • With current battlefield environment relying heavily on Network Centric Warfare(NCW), existing weaponary systems are evolving into a new concept that converges IT technology. Majority of the weaponary systems are implemented with numerous embedded softwares which makes such softwares a key factor influencing the performance of such systems. Furthermore, due to the advancements in both IoT technoogies and embedded softwares cyber threats are targeting various embedded systems as their scope of application expands in the real world. Weaponary systems have been developed in various forms from single systems to interlocking networks. hence, system level cyber security is more favorable compared to application level cyber security. In this paper, a secure real-time operating system has been designed, implemented and measured to protect embedded softwares used in weaponary systems from unknown cyber threats at the operating system level.