Qualitative and Quantitative Analysis for the Quality Control of Rhizoma Coptidis by HPLC-DAD and HPLC-ESI-MS

For quality control purpose, an approach of fingerprinting and simultaneous quantification of five major bioactive constituents of Rhizoma Coptidis was established via a high-performance liquid chromatograph coupled with a photodiode array UV detector（HPLC-DAD） and an electrospray ionization mass spectrometer（HPLC-ESI/MS） The compounds were identified on the basis of the comparison of their mass spectra with literature data and those of standard samples and quantified by the HPLC-DAD method. Baseline separation was achieved on an XTerra C18 column（5 μm, 250 mm×4.6 mm i. d.） with linear gradient elution of formate buffer（consisting of 0.5% formic acid, adjusted to pH=4.5 with ammonia） and acetonitrile（consisting of 0.2% formic acid and 0.2% triethylamine）. The me- thod was validated for linearity（r^2〉0.9995）, repeatability（RSD〈3.1%）, intra- and inter-day precision（RSD〈1.8%） with recovery（99.9%-105.1%）, limits of detection（0.15-0.35 μg/mL）, and limits of quantification（0.53-0.82 μg/mL）. The similarities of 32 batches of Rhizoma Coptidis and their classification according to their manufacturers were based on the retention time and peak areas of the characteristic compounds. The five compounds were selected for quality assessment ofRhizoma coptidis via partial least squares analysis（PLS）.

Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics

In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and compliance.Pharmaceutical specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered appropriately.Conformance of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance criteria.Quality attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the specifications.Acceptance criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric specifications.Discussed in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial monographs.Outlooks are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.

QUALITY CONTROL OF SEMICONDUCTOR PACKAGING BASED ON PRINCIPAL COMPONENTS ANALYSIS

5 critical quality characteristics must be controlled in the surface mount and wire-bond process in semiconductor packaging. And these characteristics are correlated with each other. So the principal components analysis（PCA） is used in the analysis of the sample data firstly. And then the process is controlled with hotelling T^2 control chart for the first several principal components which contain sufficient information. Furthermore, a software tool is developed for this kind of problems. And with sample data from a surface mounting device（SMD） process, it is demonstrated that the T^2 control chart with PCA gets the same conclusion as without PCA, but the problem is transformed from high-dimensional one to a lower dimensional one, i.e., from 5 to 2 in this demonstration.

The Synthetic Effect of Magnetorheological Finishing Technology:Analysis,Modeling,and Control

The controllable key factors in magnetorheological finishing device were studied to determine their influence on efficiency of magnetorheological finishing(MRF)and surface of MRF,as well as interaction between efficiency and surface.Based on theoretical and experimental research,the law of material removal was explored and a new process variable based material removal model(PVMR)was proposed.The experimental findings demonstrate that PVMR reveals the law of the material removal with introduction of three concepts and makes a material removal function z(y i)where the magnetorheological finishing process parameters are considered since they are easy to control and adjust.So the material function of this model is quadratic curve function which is readily suitable for stability and online control magnetorheological finishing.

The Role of Blood Station Quality Management System in the Quality Control of Blood Collection

With the continuous development of China’s medical industry in recent years,relevant staff has also paid more attention to the quality management of blood stations,and China has gradually improved during the setting of laws and regulations for blood station quality management.The policies set by the Chinese government have been fully implemented through the reasonable implementation of relevant staff.With the continuous development of China’s medical industry in recent years,relevant staff have also paid more attention to the quality management of blood stations,and China has gradually improved during the setting of laws and regulations for blood station quality management.The policies set by the Chinese government have been fully implemented through the reasonable implementation of relevant staff.On this basis,the management model of the Chinese blood station has been continuously innovated in the application process,and the blood collection work of the Chinese blood station has been greatly developed.However,when the blood station in China is conducting blood collection,its quality control program is still not fully mature.Therefore,in this context,it is necessary to do a good job in the construction of the corresponding blood station quality management system and make effective adjustments,which will give full play to the role of the management system in the quality control process of blood collection.In this paper,the construction plan of the blood station quality management system is analyzed to explore the role of the blood station quality management system in the process of blood collection quality control,aiming to provide assistance for the quality management of blood collection in China.

Feasibility analysis and online adjustment of constraints in model predictive control integrated with soft sensor

Feasibility analysis of soft constraints for input and output variables is critical for model predictive control(MPC).When encountering the infeasible situation, some way should be found to adjust the constraints to guarantee that the optimal control law exists. For MPC integrated with soft sensor, considering the soft constraints for critical variables additionally makes it more complicated and difficult for feasibility analysis and constraint adjustment. Therefore, the main contributions are that a linear programming approach is proposed for feasibility analysis, and the corresponding constraint adjustment method and procedure are given as well. The feasibility analysis gives considerations to the manipulated, secondary and critical variables, and the increment of manipulated variables as well. The feasibility analysis and the constraint adjustment are conducted in the entire control process and guarantee the existence of optimal control. In final, a simulation case confirms the contributions in this paper.

Risk Analysis and Quality Control of Cosmetic Raw Materials

The present situation of cosmetic raw materials has been introduced,mainly including the measures of risk analysis and quality control for cosmetic raw materials.Through the inspection of cosmetic raw materials,the formulation design and development,and the incoming management,the departments in the enterprise have worked together to achieve the risk analysis and quality control of cosmetic raw materials,to ensure the quality and safety of cosmetics.

A survey on the status of semen analysis in 118 laboratories in China

Collecting baseline information on how laboratories perform testing is a reasonable first step towards establishing intra- and inter-laboratory standardization and quality control for semen analysis. We carried out a survey of the laboratories performing the testing in China's Mainland. A questionnaire, composed of 36 questions covering all aspects of semen analysis, was designed, and a copy was distributed to each of the 145 laboratories. Of these, 118 laboratories completed the questionnaires. The survey results showed that semen volume was measured visually in 53.6% （59/110） of the responding laboratories, and 70.9% （73/103） of laboratories analysed incompletely liquefied semen without any treatment. In addition, both manual-microscopic and computer-assisted semen-analysis systems were applied to analyse sperm concentration, motility and morphology. However, more than five methods were employed in routine sperm staining. An enzyme-linked immunosorbent assay was commonly used for determining whether antisperm antibodies were present. Several seminal biochemical markers were analysed in only 27.1% （32/118） of the responding laboratories. Generally, there was a lack of intra- and inter-laboratory quality control measures for semen analysis in all laboratories responding to this survey. In conclusion, the methods of semen analysis and the interpretation of test results in the surveyed laboratories differed markedly. In particular, many laboratories employed methods other than those recommended by the World Health Organization Laboratory Manual for the Examination of Human Semen and Sperm- cervical Mucus Interaction （1999）. These findings suggest an urgent need for the standardization of semen analysis with acceptable quality controls for each parameter to make the results repeatable and meaningful.

Quality assurance and quality control in the laboratory andrology

Quality assurance （QA） and quality control （QC） are fundamental aspects of any laboratory measurement. However, in comparison with other medical disciplines, the need for QA and QC in laboratory andrology has been recognized only recently. Furthermore, there is evidence that the effort required to undertake QA and QC has not been wholly welcomed by some clinicians. Nevertheless, accrediting bodies and regulatory authorities increasingly require evidence that laboratories have effective QA and QC measures in place because both are central to the quality management processes. Following the publication of the 5th edition of the World Health Organization Laboratory Manual, existing QA and QC systems will need to be updated to take into account some of the methodological changes recommended by the manual. Three of these are discussed in this commentary; they relate to： （i） the move to infer semen volume from its weight; （ii） the re-classification of sperm motility grades from four to three; and （iii） the publication of a lower reference limit for morphology of 4% （with a corresponding 95% confidence interval of 3%-4%）. The importance of QA and QC in all laboratory tests, including up and coming new tests to assess sperm DNA integrity, is discussed. The need for adequate initial training and continuing professional development programmes to support laboratory scientists performing andrology is also described.

Quality analysis of commercial samples of Ziziphi spinosae semen(suanzaoren) by means of chromatographic fingerprinting assisted by principal component analysis

Due to the scarcity of resources of Ziziphi spinosae semen （ZSS）, many inferior goods and even adulterants are generally found in medicine markets. To strengthen the quality control, HPLC fingerprint common pattern established in this paper showed three main bioactive compounds in one chromatogram simultaneously. Principal component analysis based on DAD signals could discriminate adulterants and inferiorities. Principal component analysis indicated that all samples could be mainly regrouped into two main clusters according to the first principal component （PC1, redefined as Vicenin II） and the second principal component （PC2, redefined as zizyphusine）. PC1 and PC2 could explain 91.42%of the variance. Content of zizyphusine fluctuated more greatly than that of spinosin, and this result was also confirmed by the HPTLC result. Samples with low content of jujubosides and two common adulterants could not be used equivalently with authenticated ones in clinic, while one reference standard extract could substitute the crude drug in pharmaceutical production. Giving special consideration to the well-known bioactive saponins but with low response by end absorption, a fast and cheap HPTLC method for quality control of ZSS was developed and the result obtained was commensurate well with that of HPLC analysis. Samples having similar fingerprints to HPTLC common pattern targeting at saponins could be regarded as authenticated ones. This work provided a faster and cheaper way for quality control of ZSS and laid foundation for establishing a more effective quality control method for ZSS.

Quality Control on Crimping of Large Diameter Welding Pipe

Crimping is used in production of large diameter submerged-arc welding pipes. Many researches are focused on crimping in certain manufacturing mode of welding pipe. The application scopes of research achievements become limited due to lack of uniformity in theoretical analysis. In order to propose a crimping prediction method in order to control forming quality, the theory model of crimping based on elastic-plastic mechanics is established. The main technical parameters are determined by theoretical analysis, including length of crimping, base radius of punch, terminal angle of punch, base radius of die, terminal angle of die and horizontal distance between punch and die. In addition, a method used to evaluate the forming quality is presented, which investigates the bending angle after springback, forming force, straight edge length and equivalent radius of curvature. In order to investigate the effects of technical parameters on forming quality, a two-dimensional finite element model is established by finite element software ABAQUS. The finite element model is verified in that its shapes error is less than 5% by comparable experiments, which shows that their geometric precision meets demand. The crimping characteristics is obtained, such as the distribution of stress and strain and the changes of forming force, and the relation curves of technical parameters on forming quality are given by simulation analysis. The sensitivity analysis indicates that the effects of length of crimping, technical parameters of punch on forming quality are significant. In particular, the data from simulation analysis are regressed by response surface method （RSM） to establish prediction model. The feasible technical parameters are obtained from the prediction model. This method presented provides a new thought used to design technical parameters of crimping forming and makes a basis for improving crimping forming quality.

Recent advancement of chemical imaging in pharmaceutical quality control:From final product testing to industrial utilization

Chemical imaging(CI)possesses a strong ability of pharmaceutical analysis.Its great strength relies on the integration of traditional spectroscopy(one dimension)and imaging technique(two dimensions)to generate three-dimensional data hypercubes.Data pre-processing or processing methods are proposed to analyze vast data matrixes and thereby realizing different research objectives.In this review paper,various pharmaceutical applications of quality control over the past few years are summed up in two groups of final product test and industrial utilization.The scope of"quality control"here includes traditional analytical use,process understanding and manufactural control.Finally,two major challenges about undesirable sample geometry and lengthy acquisition time are discussed for prospective commercial or industrial application.

Science Letters:Crossover randomized controlled trial of the electronic version of the Chinese SF-36

Objectives:to verify the feasibility and reliability of the electronic version of Chinese SF-36 based on the Quality-of-Life-Recorder. Design: A crossover randomized controlled trial, comparing a paper-based and an electronic version of the Chinese SF-36, was conducted. According to generated random numbers, interviewees were asked to fill out either the electronic version or the paper version first. The second version was filled in after a pause of at least 10 min. Settings and participants: One group of 100 medical students at the School of Medicine of Zhejiang University and the other group of 50 outpatients at a clinic for general practice in Hangzhou City (China) were eventually recruited in this study. Results: The acceptance of the electronic version was good (60% of medical students and 84% of outpatients preferred the electronic version). At the level of eight-scale scores, the mean-difference for each scale (except for general health) between the two versions was less than 5%. At the level of 36 questions, the percentage of "exact agreement" ranged within 64%～99%; the percentage of "global agreement" ranged within 72%～99%; 77% of the kappa coefficients demonstrated "good/excellent agreement" and 23% of the kappa coefficients demonstrated "medium agreement". Conclusion: This study, for the first time, can provide empirical basis for the confirmation of the feasibility and reliability of the electronic version of the Chinese SF-36 and may provide an impulse towards widespread deployment of the Quality-of-Life-Recorder in Chinese populations.

Chemical fingerprinting of Su-He-Xiang-Wan and attribution of major characteristic peaks for its quality control by GC-MS

A simple and facile gas chromatography-mass spectrometer （GC-MS） fingerprint of Su-He-Xiang-Wan （SHXW） was developed, the similarity analysis was conducted, and attribution of the major characteristic peaks was identified for SHXW quality control. GC-MS analysis was performed on a QP2010 instrument （Shimadzu, Japan） equipped with a capillary column of RTX-5MS. The column temperature was initiated at 50℃, held for 5 min, increased at the rate of 3 ℃/min to 120 ℃, held for 2 min, and then increased at the rate of 4 ℃/min to 220℃, held for 10 min. Helium carrier gas was used at a constant flow rate of 1.3 mL/min. Mass conditions were ionization voltage, 70 eV; injector temperature, 250℃; ion source temperature, 250 ℃; splitting ratio, 30：1; full scan mode in the 40-500 Da mass ranges with rate of 0.2 s per scan. Attribution of the major characteristic peaks was identified for SHXW by comparing the chemical standards, references of Chinese herbal medicines and the negative controls of prescription samples （NC） of SHXW. With the help of the temperature-programmed retention indices （PTRIs） used together with mass spectra and chemical standards, 25 major characteristic peaks have been identified. Nine volatile medicinal materials were identified in the prescription of SHXW by attributing to the 27 major characteristic peaks. The results demonstrate that the proposed method is a powerful approach to quality control of complex herbal medicines.

A Study of Detection of Outliers for Working and Non-Working Days Air Quality in Kolkata, India: A Case Study

A variety of factors affect air quality, making it a difficult issue. The level of clean air in a certain area is referred to as air quality. It is challenging for conventional approaches to correctly discover aberrant values or outliers due to the significant fluctuation of this sort of data, which is influenced by Climate change and the environment. With accelerating industrial expansion and rising population density in Kolkata City, air pollution is continuously rising. This study involves two phases, in the first phase imputation of missing values and second detection of outliers using Statistical Process Control (SPC), and Functional Data Analysis (FDA), studies to achieve the efficacy of the outlier identification methodology proposed with working days and Nonworking days of the variables NO2, SO2, and O3, which were used for a year in a row in Kolkata, India. The results show how the functional data approach outshines traditional outlier detection methods. The outcomes show that functional data analysis vibrates more than the other two approaches after imputation, and the suggested outlier detector is absolutely appropriate for the precise detection of outliers in highly variable data.

Seismic Data Quality Control and Interpolation Using Principal Component Analysis

Commonly, seismic data processing procedures, such as stacking and prestack migration, require the ability to detect bad traces/shots and restore or replace them by interpolation, particularly when the seismic observations are noisy or there are malfunctioned components in the recording system. However, currently available trace/shot interpolation methods in the spatial or Fourier domain must deal with requirements such as evenly sampled traces/shots, infinite bandwidth of the signals, and linear seismic events. In this paper, we present a novel method, termed the E-S (eigenspace seismic) method, using principal component analysis (PCA) of the seismic signal to address the issue of reliable detection or interpolation of bad traces/shots. The E-S method assumes the existence of a correlation between the observed seismic entities, such as trace or shot gathers, making it possible to estimate one of these entities from all others for interpolation or seismic quality control. It first transforms a trace (or shot) gather into an eigenspace using PCA. Then in the eigenspace, it treats every trace as a point with its loading scores of PCA as its coordinates. Simple linear, bilinear, or cubic spline 1 dimensional (1D) interpolation is used to determine PCA loading scores for any arbitrary coordinate in the eigenspace, which are then used to construct an interpolated trace for the desired position in physical space. This E-S method works with either regular or irregular sampling and, unlike various other published methods, it is well-suited for band-limited seismic records with curvilinear reflection events. We developed related algorithms and applied these to processed synthetic and offshore seismic survey data with or without simulated noises to demonstrate their performance. By comparing the interpolated and observed seismic traces, we find that the E-S method can effectively assess the quality of the trace, and restore poor quality data by interpolation. The successful processing of synthetic and real data using the E-S method presented in this approach will be widely applicable to seismic trace/shot interpolation and seismic quality control.

Off-Line Quality Control in Bioproducts Processing: A Case Study in Greece

In the present article we study the production of grape molasses. Data drawn from a specified biolaboratory, are properly analyzed in order to detect factors that affect significantly the Brix value and the volatile acidity of the final product. The ground that is used for planting and a variety of grapes have been taken into account. Off-line statistical quality control techniques have been employed and the outcomes are displayed and discussed in detail.

The usefulness and significance of assessing rapidly progressive spermatozoa

It is possible and clinically relevant to distinguish between slow and rapid progressive spermatozoa in basic semen analysis. This is discussed in light of the different purposes of semen analysis for the subfertile couple and the male patient. The two groups of progressive spermatozoa should be distinguished to help ensure that pertinent information available in the semen sample is not neglected.

Impact of Different Grinding Aids on Standard Deviation in X-Ray Fluorescence Analysis of Cement Raw Meal

X-ray fluorescence (XRF) analysis utilizes particle size which is resulted from milling of a material. The milling ensures uniform and fine grained powder. The finer and more uniform the particle size is, the better the result and easier it is for material quality control. To ensure uniformity in particle size and finer powder, a comparative analysis was conducted with different grinding aids and pressed pellet method was used in obtaining analysis results. Pressed pellets of cement raw meal sample milled with different grinding aids (graphite, aspirin and lithium borate) were subjected to XRF. Graphite produced better particle size uniformity with a corresponding standard deviation that made quality control of raw meal easier and better than aspirin and lithium borate.

Thermal Decomposition of Some Cardiovascular Drugs (Telmisartane, Cilazapril and Terazosin HCL)

Thermal analysis of some antihypertensive drugs, Telmisartan, Cilazapril and Terazosin HCL was achieved. Thermogravimetry, derivative thermogravimetry and differential thermal analysis were used through the work. Thermogravimetric parameters such as activation energy, frequency factor and reaction order were calculated. The results show the stability value decrease in the order Telmisartan > Cilazapril > Terazosin. This method can be used in the quality control of pharmaceutical compounds because it is simple, fast and cheap.