Digital twins have emerged as a promising technology for maintenance applications,enabling organizations to simulate and monitor physical assets to improve their performance.In Operation and Maintenance(O&M),digit...Digital twins have emerged as a promising technology for maintenance applications,enabling organizations to simulate and monitor physical assets to improve their performance.In Operation and Maintenance(O&M),digital twin facilitates the diagnosis and prognosis of critical assets,forming the basis for smart maintenance planning and reducing downtime.However,there is a lack of standardized approaches for the qualifications of digital twins in maintenance,leading to low trustworthiness and limiting its application.This paper proposes a novel framework for the qualifications of digital twins in maintenance based on five pillars,namely fidelity,smartness,timeliness,integration,and standard compliance.We demonstrate the effectiveness of the framework through two case studies,showing how it can be implemented on digital twins for preventive maintenance and condition-based maintenance.Our proposed framework can help organizations across different industrial domains develop and implement digital twins in maintenance more effectively and efficiently,leading to significant benefits in terms of cost reduction,performance improvement,and sustainability.展开更多
In this 21st century a lot of women are experiencing marital challenges due to the various and important roles they perform in the home and in the society,which may require some psychological remedies.The research was...In this 21st century a lot of women are experiencing marital challenges due to the various and important roles they perform in the home and in the society,which may require some psychological remedies.The research was on marital stress and married working women:the role of coping strategies,self-concept and educational qualification.Three hundred and seventy-seven(377)participants whose ages were between 25 to 55 years(mean 40.63 and SD 7.59)participated in the study.Three research instruments were used for data collection while three-way Analysis of Variance was used for data analysis.Result disclosed that emotion-focused strategies yielded less manifestation of marital stress(1,369)=4.44,sig.=.036;in the same manner,those with higher educational qualification presented less manifestation of marital stress(1,369)=6.33,sig.=.012.It was equally specified that coping strategies together with self-concept had a joint impact on marital stress(1,369)=5.88,sig.=.016;a joint influence was also observed between self-concept and educational qualification on marital stress(1,369)=4.18,sig.=.042.Hence,married working women should strive for higher education and also use emotion-focused coping strategies in dealing with marital stress.展开更多
AAS was qualified as per pharmacopoeia requirements. Copper, manganese, mercury and cadmium hallow cathode lamps were used for qualification purposes. Design qualification and installation qualification met the criter...AAS was qualified as per pharmacopoeia requirements. Copper, manganese, mercury and cadmium hallow cathode lamps were used for qualification purposes. Design qualification and installation qualification met the criteria of user requirements. Wavelength accuracy and reproducibility, resolution and baseline stability are in compliance with user requirements. Characteristics concentration or sensitivity, detection limit and characteristics mass were performed as a part of operational qualification which is 0.062 μg/mL, 0.00354 μg/mL, 1.41 pg respectively. Results of % RSD for precision study is 0.352 and 0.487 for flame and graphite furnace mode respectively fulfilled criteria of qualification. Performance qualification results of 20 consecutive days demonstrate the predetermined specification. Analytical instrument qualification and method validation relationship is also described by assay performed on haemodialysis concentrate. Good precision (2) greater than 0.9997 for potassium, magnesium and calcium linear curves, lower detection limits for all three ingredients and robust assay data as a part of validation studies conform the qualified AAS for its intended application.展开更多
A qualification test for the reliability of a newly-developed Diver Gas Recovery System（DGRS）was carried out in the Naval Medical Research Institute of the People’s Liberation Army,Chinafrom March 29 to April 2,199...A qualification test for the reliability of a newly-developed Diver Gas Recovery System（DGRS）was carried out in the Naval Medical Research Institute of the People’s Liberation Army,Chinafrom March 29 to April 2,1995.A sequential test plan of high discrimination ratio for the mean time be-tween failures（MTBF）was adopted.The test procedures simulated those of a 300 msw dive.A hyperbaricbreathing machine was used for the simulation of diver’s respiratory functions.Parameters,such as divingdepth,respiratory minute volume（RMV）,CO<sub>2</sub> production,gas flow rate,partial pressure of carbondioxide,and ambient temperature and himidity were all displayed and recorded with a microcomputer sys-tem.The results indicated that no failure occurred during the 91.5 h operation.According to the accept-ance and rejection criteria specified in the statistical test plan,a no-failure score in the 88 h operation is ac-ceptable.Therefore,the DGRS has been demonstrated to meet the requirements of MTBF specified in thecontract.展开更多
Based on the theoretical inference and experiment verification,a method was proposed to carry out the accelerated reliability qualification testing. First,theoretical inference was used to get the acceleration coeffic...Based on the theoretical inference and experiment verification,a method was proposed to carry out the accelerated reliability qualification testing. First,theoretical inference was used to get the acceleration coefficients of super Gauss vibration stress and temperature stress. Then, by applying these coefficients, an accelerated reliability qualification testing curve was obtained from the standard tests. Finally,the actual experiment on a digital marine control device was carried out under the proposed testing method.The experiment result shows that the proposed method can reduce the total experiment time and improve the efficiency of the reliability qualification test.展开更多
Some remarks are made on the use of the Abadie constraint qualification, the Guignard constraint qualifications and the Guignard regularity condition in obtaining weak and strong Kuhn-Tucker type optimality conditions...Some remarks are made on the use of the Abadie constraint qualification, the Guignard constraint qualifications and the Guignard regularity condition in obtaining weak and strong Kuhn-Tucker type optimality conditions in differentiable vector optimization problems.展开更多
With the increasing demand for new technologies in HPHT (high pressure high temperature) wells, more and more attention has been paid to the system of technical qualifications. Most established norms, standards and re...With the increasing demand for new technologies in HPHT (high pressure high temperature) wells, more and more attention has been paid to the system of technical qualifications. Most established norms, standards and recommended practices are written in prescribed formats, setting out methods, procedures and acceptance criteria for product design, manufacture and testing. However, established norms, standards or recommended practices may not adequately cover new technologies or applications. The technical qualification system is established in this paper, which can identify the potential failure modes and some activities in order to control the uncertainties and increase confidence of using new technology. A risk-based technical qualification system is used to assess non-traditional operations. It includes following seven main steps: system breakdown, technology assessment and classification, technical novelty, failure model and risk analysis, risk-based qualification planning and participation level development. The core of technical qualification system is to understand the ways and causes of system failure, and to carry out corresponding activities to provide evidence that the system will not fail. Through the technical identification process, the detailed equipment/operation specifications and identification requirements have been formulated. Different levels of participation are assigned for each eligibility activity, depending on the hazard and risk. It is proved that the application of the technical qualification principle in the systematic evaluation and control of the risks of new technologies or new applications is successful. In HPHT wells in particular, operators can move from a reactive approach to a proactive approach.展开更多
Recently, there is a growing interest in seismic qualification of ridges, buildings and mechanical equipment worldwide due to increase of accidents caused by earthquake. Severe earthquake can bring serious problems in...Recently, there is a growing interest in seismic qualification of ridges, buildings and mechanical equipment worldwide due to increase of accidents caused by earthquake. Severe earthquake can bring serious problems in the wind turbines and eventually lead to an interruption to their electric power supply. To overcome and prevent these undesirable problems, structural design optimization of a small vertical axis wind turbine has performed, in this study, for seismic qualification and lightweight by using a Genetic Algorithm (GA) subject to some design constraints such as the maximum stress limit, maximum deformation limit, and seismic acceleration gain limit. Also, the structural design optimizations were conducted for the four different initial design variable sets to confirm robustness of the optimization algorithm used. As a result, all the optimization results for the 4 different initial designs showed good agreement with each other properly. Thus the structural design optimization of a small vertical-axis wind turbine could be successfully accomplished.展开更多
With a view to standardizing the business operationsrelating to foreign investment of domestic and overseas secu-rities organizations and protecting the legitimate rights andinterests of investors,the China Security R...With a view to standardizing the business operationsrelating to foreign investment of domestic and overseas secu-rities organizations and protecting the legitimate rights andinterests of investors,the China Security Regulatory Commis-sion has promulgated the Provisional Regulations on theManagement of the Qualification of Domestic and OverseasSecurities Organizations to Engage in the Business Opera-tions concerning Shares Owned by Foreign Investors.TheseRegulations enter into force on December 1.1996.The wholetext is as follows:Chapter 1 General PrinciplesArticle 1 With a view to standardizing the businessoperations of domestic and overseas securities organizationswhich relate to shares owned by foreign investors and pro-展开更多
Investigation of optimality conditions has been one of the most interesting topics in the theory of multiobjective optimisation problems (MOP). To derive necessary optimality conditions of MOP, we consider assumptions...Investigation of optimality conditions has been one of the most interesting topics in the theory of multiobjective optimisation problems (MOP). To derive necessary optimality conditions of MOP, we consider assumptions called constraints qualifications. It is recognised that Guignard Constraint Qualification (GCQ) is the most efficient and general assumption for scalar objective optimisation problems;however, GCQ does not ensure Karush-Kuhn Tucker (KKT) necessary conditions for multiobjective optimisation problems. In this paper, we investigate the reasons behind that GCQ are not allowed to derive KKT conditions in multiobjective optimisation problems. Furthermore, we propose additional assumptions that allow one to use GCQ to derive necessary conditions for multiobjective optimisation problems. Finally, we also include sufficient conditions for multiobjective optimisation problems.展开更多
Consider an optimal procurement strategy for fresh produce,which is a type of perishable product.Due to the different quality provided by each manufacturer,the fresh produce qualification rates are dissimilar.Simultan...Consider an optimal procurement strategy for fresh produce,which is a type of perishable product.Due to the different quality provided by each manufacturer,the fresh produce qualification rates are dissimilar.Simultaneously,consumers demand is influenced by the freshness and price of products,as a result,the demand in the market is not fixed.In this scenario,how a particular retailer should develop an optimal procurement strategy will be a core issue in supply chain management.In order to address the above questions,the Bayesian approach is adopted to explore retailer optimal procurement strategies with uncertainty about product supply and market demand.Finally,simulation data are used to analyse the results of the proposed model and expected non-random model to illustrate the validity and feasibility of the proposed model.展开更多
The'European Level 5 Area'(EL5A)is a relatively new concept for Europe,giving an excellent opportunity to link the sectors for Vocational Education and Training(VET)and Higher Education(HE)to each other.Then i...The'European Level 5 Area'(EL5A)is a relatively new concept for Europe,giving an excellent opportunity to link the sectors for Vocational Education and Training(VET)and Higher Education(HE)to each other.Then it is about looking at qualifications at level 5 of the European Qualifications Framework(EQF)for Lifelong Learning and using them展开更多
This paper derives a new constraint qualification for nondifferential convex programming problem, by using the distance between the feasible set and the perturbed feasible sets. If the feasible sot is bounded, then th...This paper derives a new constraint qualification for nondifferential convex programming problem, by using the distance between the feasible set and the perturbed feasible sets. If the feasible sot is bounded, then this constraint qualification is weaker than Stater’s constrains qualification.展开更多
OF the 517 large and small cities in the country, more than 300 have women mayors and vice mayors. These women play an important role in the construction and development of their cities. Ordinary Chinese people like t...OF the 517 large and small cities in the country, more than 300 have women mayors and vice mayors. These women play an important role in the construction and development of their cities. Ordinary Chinese people like to call their local officials "father-and- mother officials," but these展开更多
Two dynamic grey models DGM (1, 1) for the verification cycle and the lifecycle of measuring instrument based on time sequence and frequency sequence were set up, according to the statistical feature of examination da...Two dynamic grey models DGM (1, 1) for the verification cycle and the lifecycle of measuring instrument based on time sequence and frequency sequence were set up, according to the statistical feature of examination data and weighting method. By a specific case, i.e. vernier caliper, it is proved that the fit precision and forecast precision of the models are much higher, the cycles are obviously different under different working conditions, and the forecast result of the frequency sequence model is better than that of the time sequence model. Combining dynamic grey model and auto-manufacturing case the controlling and information subsystems of verification cycle and the lifecycle based on information integration, multi-sensor controlling and management controlling were given. The models can be used in production process to help enterprise reduce error, cost and flaw.展开更多
A rapid GC-FID method was developed to simultaneously determine residual levels of triethylamine(TEA), 1,1,3,3-tetramethylguanidine(TMG), and diisopropylamine(DIPA) in the synthetic route of an active pharmaceutical i...A rapid GC-FID method was developed to simultaneously determine residual levels of triethylamine(TEA), 1,1,3,3-tetramethylguanidine(TMG), and diisopropylamine(DIPA) in the synthetic route of an active pharmaceutical ingredient(API). Due to the severe absorption of amines on GC stationary phases,GC columns with various stationary phases were evaluated for optimal peak shape and reproducibility.The final conditions used the Agilent CP-Volamine column to resolve the three amines in 12 min. Various inlet liners were also screened to further improve the sensitivity of the analysis. The Restek Siltek~? liner was selected to achieve the desired detectability for the method. The quantitation limits were 4, 3, and 4 mg/mL for TEA, DIPA, and TMG in the presence of API, respectively. All three amines showed good linearity(r > 0.999) and recoveries(> 90%) over the concentration range of 3 to 16 mg/mL. The testing of residual amines was initially performed at the penultimate stage of the synthesis. However, this work demonstrates that TMG can act as a proton sponge to react with salicylic acid, the counter ion of the penultimate, to form a volatile component that elutes at a different retention time. Consequently, in the final method, these three amines were monitored in the final API to circumvent the matrix interference.Key parameters of the method were qualified per method validation requirements in ICH guidelines. The method was successfully applied for batch testing during development and implemented as an inprocess control procedure at manufacturing sites.展开更多
In order to solve the problem of insufficient integration of school-enterprise supervisors in the current school-enterprise cooperation model,this article introduces the ideas and results of the construction of a team...In order to solve the problem of insufficient integration of school-enterprise supervisors in the current school-enterprise cooperation model,this article introduces the ideas and results of the construction of a team with double-qualified instructors majored in software engineering.Specifically,the integration of production and education are carried out in three stages,i.e.,enterprise cooperation courses,enterprise internship,and graduation design(internship),by taking the software engineering major of the School of Information and Software Engineering of the University of Electronic Science and Technology of China as a case study.展开更多
文摘Digital twins have emerged as a promising technology for maintenance applications,enabling organizations to simulate and monitor physical assets to improve their performance.In Operation and Maintenance(O&M),digital twin facilitates the diagnosis and prognosis of critical assets,forming the basis for smart maintenance planning and reducing downtime.However,there is a lack of standardized approaches for the qualifications of digital twins in maintenance,leading to low trustworthiness and limiting its application.This paper proposes a novel framework for the qualifications of digital twins in maintenance based on five pillars,namely fidelity,smartness,timeliness,integration,and standard compliance.We demonstrate the effectiveness of the framework through two case studies,showing how it can be implemented on digital twins for preventive maintenance and condition-based maintenance.Our proposed framework can help organizations across different industrial domains develop and implement digital twins in maintenance more effectively and efficiently,leading to significant benefits in terms of cost reduction,performance improvement,and sustainability.
文摘In this 21st century a lot of women are experiencing marital challenges due to the various and important roles they perform in the home and in the society,which may require some psychological remedies.The research was on marital stress and married working women:the role of coping strategies,self-concept and educational qualification.Three hundred and seventy-seven(377)participants whose ages were between 25 to 55 years(mean 40.63 and SD 7.59)participated in the study.Three research instruments were used for data collection while three-way Analysis of Variance was used for data analysis.Result disclosed that emotion-focused strategies yielded less manifestation of marital stress(1,369)=4.44,sig.=.036;in the same manner,those with higher educational qualification presented less manifestation of marital stress(1,369)=6.33,sig.=.012.It was equally specified that coping strategies together with self-concept had a joint impact on marital stress(1,369)=5.88,sig.=.016;a joint influence was also observed between self-concept and educational qualification on marital stress(1,369)=4.18,sig.=.042.Hence,married working women should strive for higher education and also use emotion-focused coping strategies in dealing with marital stress.
文摘AAS was qualified as per pharmacopoeia requirements. Copper, manganese, mercury and cadmium hallow cathode lamps were used for qualification purposes. Design qualification and installation qualification met the criteria of user requirements. Wavelength accuracy and reproducibility, resolution and baseline stability are in compliance with user requirements. Characteristics concentration or sensitivity, detection limit and characteristics mass were performed as a part of operational qualification which is 0.062 μg/mL, 0.00354 μg/mL, 1.41 pg respectively. Results of % RSD for precision study is 0.352 and 0.487 for flame and graphite furnace mode respectively fulfilled criteria of qualification. Performance qualification results of 20 consecutive days demonstrate the predetermined specification. Analytical instrument qualification and method validation relationship is also described by assay performed on haemodialysis concentrate. Good precision (2) greater than 0.9997 for potassium, magnesium and calcium linear curves, lower detection limits for all three ingredients and robust assay data as a part of validation studies conform the qualified AAS for its intended application.
文摘A qualification test for the reliability of a newly-developed Diver Gas Recovery System（DGRS）was carried out in the Naval Medical Research Institute of the People’s Liberation Army,Chinafrom March 29 to April 2,1995.A sequential test plan of high discrimination ratio for the mean time be-tween failures（MTBF）was adopted.The test procedures simulated those of a 300 msw dive.A hyperbaricbreathing machine was used for the simulation of diver’s respiratory functions.Parameters,such as divingdepth,respiratory minute volume（RMV）,CO<sub>2</sub> production,gas flow rate,partial pressure of carbondioxide,and ambient temperature and himidity were all displayed and recorded with a microcomputer sys-tem.The results indicated that no failure occurred during the 91.5 h operation.According to the accept-ance and rejection criteria specified in the statistical test plan,a no-failure score in the 88 h operation is ac-ceptable.Therefore,the DGRS has been demonstrated to meet the requirements of MTBF specified in thecontract.
文摘Based on the theoretical inference and experiment verification,a method was proposed to carry out the accelerated reliability qualification testing. First,theoretical inference was used to get the acceleration coefficients of super Gauss vibration stress and temperature stress. Then, by applying these coefficients, an accelerated reliability qualification testing curve was obtained from the standard tests. Finally,the actual experiment on a digital marine control device was carried out under the proposed testing method.The experiment result shows that the proposed method can reduce the total experiment time and improve the efficiency of the reliability qualification test.
文摘Some remarks are made on the use of the Abadie constraint qualification, the Guignard constraint qualifications and the Guignard regularity condition in obtaining weak and strong Kuhn-Tucker type optimality conditions in differentiable vector optimization problems.
文摘With the increasing demand for new technologies in HPHT (high pressure high temperature) wells, more and more attention has been paid to the system of technical qualifications. Most established norms, standards and recommended practices are written in prescribed formats, setting out methods, procedures and acceptance criteria for product design, manufacture and testing. However, established norms, standards or recommended practices may not adequately cover new technologies or applications. The technical qualification system is established in this paper, which can identify the potential failure modes and some activities in order to control the uncertainties and increase confidence of using new technology. A risk-based technical qualification system is used to assess non-traditional operations. It includes following seven main steps: system breakdown, technology assessment and classification, technical novelty, failure model and risk analysis, risk-based qualification planning and participation level development. The core of technical qualification system is to understand the ways and causes of system failure, and to carry out corresponding activities to provide evidence that the system will not fail. Through the technical identification process, the detailed equipment/operation specifications and identification requirements have been formulated. Different levels of participation are assigned for each eligibility activity, depending on the hazard and risk. It is proved that the application of the technical qualification principle in the systematic evaluation and control of the risks of new technologies or new applications is successful. In HPHT wells in particular, operators can move from a reactive approach to a proactive approach.
文摘Recently, there is a growing interest in seismic qualification of ridges, buildings and mechanical equipment worldwide due to increase of accidents caused by earthquake. Severe earthquake can bring serious problems in the wind turbines and eventually lead to an interruption to their electric power supply. To overcome and prevent these undesirable problems, structural design optimization of a small vertical axis wind turbine has performed, in this study, for seismic qualification and lightweight by using a Genetic Algorithm (GA) subject to some design constraints such as the maximum stress limit, maximum deformation limit, and seismic acceleration gain limit. Also, the structural design optimizations were conducted for the four different initial design variable sets to confirm robustness of the optimization algorithm used. As a result, all the optimization results for the 4 different initial designs showed good agreement with each other properly. Thus the structural design optimization of a small vertical-axis wind turbine could be successfully accomplished.
文摘With a view to standardizing the business operationsrelating to foreign investment of domestic and overseas secu-rities organizations and protecting the legitimate rights andinterests of investors,the China Security Regulatory Commis-sion has promulgated the Provisional Regulations on theManagement of the Qualification of Domestic and OverseasSecurities Organizations to Engage in the Business Opera-tions concerning Shares Owned by Foreign Investors.TheseRegulations enter into force on December 1.1996.The wholetext is as follows:Chapter 1 General PrinciplesArticle 1 With a view to standardizing the businessoperations of domestic and overseas securities organizationswhich relate to shares owned by foreign investors and pro-
文摘Investigation of optimality conditions has been one of the most interesting topics in the theory of multiobjective optimisation problems (MOP). To derive necessary optimality conditions of MOP, we consider assumptions called constraints qualifications. It is recognised that Guignard Constraint Qualification (GCQ) is the most efficient and general assumption for scalar objective optimisation problems;however, GCQ does not ensure Karush-Kuhn Tucker (KKT) necessary conditions for multiobjective optimisation problems. In this paper, we investigate the reasons behind that GCQ are not allowed to derive KKT conditions in multiobjective optimisation problems. Furthermore, we propose additional assumptions that allow one to use GCQ to derive necessary conditions for multiobjective optimisation problems. Finally, we also include sufficient conditions for multiobjective optimisation problems.
基金This research was funded by the National Natural Science Foundation of China(NSFC)[Grant number 71671048,71901075]National Social Science Fund of China(NSSFC)Research of Public Choice Based on Arrow Axiom System and Arrow Impossibility Theorem[Grant number 17BJL025]+2 种基金Science Foundation of Ministry of Education of China(SFMEC):Research on The Influence Mechanism Of Social Trust Based on Multi-Modal Relationship of Sharing Economy[19YJCZH278]the Co-Construction Project of Philosophy and Social Science Planning Discipline in Guangdong Province[GD18XGL37]Innovative Talents Project of general universities in Guangdong Province[2018WQNCX146].
文摘Consider an optimal procurement strategy for fresh produce,which is a type of perishable product.Due to the different quality provided by each manufacturer,the fresh produce qualification rates are dissimilar.Simultaneously,consumers demand is influenced by the freshness and price of products,as a result,the demand in the market is not fixed.In this scenario,how a particular retailer should develop an optimal procurement strategy will be a core issue in supply chain management.In order to address the above questions,the Bayesian approach is adopted to explore retailer optimal procurement strategies with uncertainty about product supply and market demand.Finally,simulation data are used to analyse the results of the proposed model and expected non-random model to illustrate the validity and feasibility of the proposed model.
文摘The'European Level 5 Area'(EL5A)is a relatively new concept for Europe,giving an excellent opportunity to link the sectors for Vocational Education and Training(VET)and Higher Education(HE)to each other.Then it is about looking at qualifications at level 5 of the European Qualifications Framework(EQF)for Lifelong Learning and using them
基金the National Natural Science Foundation of China (No.19671053).
文摘This paper derives a new constraint qualification for nondifferential convex programming problem, by using the distance between the feasible set and the perturbed feasible sets. If the feasible sot is bounded, then this constraint qualification is weaker than Stater’s constrains qualification.
文摘OF the 517 large and small cities in the country, more than 300 have women mayors and vice mayors. These women play an important role in the construction and development of their cities. Ordinary Chinese people like to call their local officials "father-and- mother officials," but these
文摘Two dynamic grey models DGM (1, 1) for the verification cycle and the lifecycle of measuring instrument based on time sequence and frequency sequence were set up, according to the statistical feature of examination data and weighting method. By a specific case, i.e. vernier caliper, it is proved that the fit precision and forecast precision of the models are much higher, the cycles are obviously different under different working conditions, and the forecast result of the frequency sequence model is better than that of the time sequence model. Combining dynamic grey model and auto-manufacturing case the controlling and information subsystems of verification cycle and the lifecycle based on information integration, multi-sensor controlling and management controlling were given. The models can be used in production process to help enterprise reduce error, cost and flaw.
文摘A rapid GC-FID method was developed to simultaneously determine residual levels of triethylamine(TEA), 1,1,3,3-tetramethylguanidine(TMG), and diisopropylamine(DIPA) in the synthetic route of an active pharmaceutical ingredient(API). Due to the severe absorption of amines on GC stationary phases,GC columns with various stationary phases were evaluated for optimal peak shape and reproducibility.The final conditions used the Agilent CP-Volamine column to resolve the three amines in 12 min. Various inlet liners were also screened to further improve the sensitivity of the analysis. The Restek Siltek~? liner was selected to achieve the desired detectability for the method. The quantitation limits were 4, 3, and 4 mg/mL for TEA, DIPA, and TMG in the presence of API, respectively. All three amines showed good linearity(r > 0.999) and recoveries(> 90%) over the concentration range of 3 to 16 mg/mL. The testing of residual amines was initially performed at the penultimate stage of the synthesis. However, this work demonstrates that TMG can act as a proton sponge to react with salicylic acid, the counter ion of the penultimate, to form a volatile component that elutes at a different retention time. Consequently, in the final method, these three amines were monitored in the final API to circumvent the matrix interference.Key parameters of the method were qualified per method validation requirements in ICH guidelines. The method was successfully applied for batch testing during development and implemented as an inprocess control procedure at manufacturing sites.
基金This work was supported by the Research and Practice of School-enterprise Collaborative Construction of Double Qualified Teachers in Software Engineering“Construction of Double Qualified Teachers in Software Engineering Based on Enterprise and School Cooperation”(Grant No.2020CJ01)the Fundamental Research Funds for the Central Universities of UESTC(Policy Research)“The System Construction of Ideological and Political Education under Training of Excellent Engineer”(Grant No.ZYGX2020ZCYJ027).
文摘In order to solve the problem of insufficient integration of school-enterprise supervisors in the current school-enterprise cooperation model,this article introduces the ideas and results of the construction of a team with double-qualified instructors majored in software engineering.Specifically,the integration of production and education are carried out in three stages,i.e.,enterprise cooperation courses,enterprise internship,and graduation design(internship),by taking the software engineering major of the School of Information and Software Engineering of the University of Electronic Science and Technology of China as a case study.
