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）.

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.

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.

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.

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.

External quality control and training of semen analysis in the Netherlands:starting point for further reduction of outcome variability

Semen analysis is characterized by high levels of intra-and inter-laboratory variability,due to a low level of standardization,high subjectivity of the assessments,and problems with automated procedures.To improve consistency of laboratory results,quality control and training of technicians are important requisites.The goals of this study are to evaluate the results of an external quality control(EQC)program and standardized training by ESHRE Basic Semen Analysis Courses(BSAC)on the variability in manual assessments of semen parameters.We performed retrospective analyses of(1)the interlaboratory variability in the Dutch EQC program and(2)the interobserver variability in BSACs for concentration,motility,and morphology assessments.EQC data showed that the interlaboratory coefficient of variation(CV)for concentration assessment decreased(range from 24.0%–97.5%to 12.7%–20.9%)but not for morphology and motility assessments.Concentration variability was lower if improved Neubauer hemocytometers were used.Morphology assessment showed highest CVs(up to 375.0%),with many outliers in the period of 2007–2014.During BSAC,a significant reduction of interobserver variability could be established for all parameters(P<0.05).The absence of an effect in the EQC program for motility and morphology might be explained by respectively the facts that motility assessment was introduced relatively late in the EQC program(since 2013)and that criteria for morphology assessment changed in time.BSAC results might have been influenced by the pretraining level of participants and the influence of external factors.Both EQC and training show positive effects on reducing variability.Increased willingness by laboratories to change their methods toward standards may lead to further improvements.

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.

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.

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.

AIAP: A Quality Control and Integrative Analysis Package to Improve ATAC-seq Data Analysis

Assay for transposase-accessible chromatin with high-throughput sequencing(ATAC-seq) is a technique widely used to investigate genome-wide chromatin accessibility. The recently published Omni-ATAC-seq protocol substantially improves the signal/noise ratio and reduces the input cell number. High-quality data are critical to ensure accurate analysis.Several tools have been developed for assessing sequencing quality and insertion size distribution for ATAC-seq data;however, key quality control(QC) metrics have not yet been established to accurately determine the quality of ATAC-seq data. Here, we optimized the analysis strategy for ATAC-seq and defined a series of QC metrics for ATAC-seq data,including reads under peak ratio(RUPr), background(BG), promoter enrichment(Pro En), subsampling enrichment(Sub En), and other measurements. We incorporated these QC tests into our recently developed ATAC-seq Integrative Analysis Package(AIAP) to provide a complete ATAC-seq analysis system, including quality assurance, improved peak calling, and downstream differential analysis. We demonstrated a significant improvement of sensitivity(20%–60%) in both peak calling and differential analysis by processing paired-end ATAC-seq datasets using AIAP. AIAP is compiled into Docker/Singularity, and it can be executed by one command line to generate a comprehensive QC report. We used ENCODE ATAC-seq data to benchmark and generate QC recommendations, and developed q ATACViewer for the userfriendly interaction with the QC report. The software, source code, and documentation of AIAP are freely available at https://github.com/Zhang-lab/ATAC-seq_QC_analysis.

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.

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

Su-He-Xiang-Wan (SHXW ) 的一条简单、灵巧的煤气的层析团分光计(GCMS ) 指纹被开发，类似分析被进行，并且主要典型山峰的归属为 SHXW 质量控制被识别。GCMS 分析在一台 QP2010 仪器上被执行(Shimadzu，日本) 与 RTX-5MS 的毛状的列装备了。列温度在 50 点被开始 ???????? 控慬獳??? 汰獵瀭畬 ?? ￣′吗？

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.

Measurement uncertainty in pharmaceutical analysis and its application

The measurement uncertainty provides complete information about an analytical result. This is very important because several decisions of compliance or non-compliance are based on analytical results in pharmaceutical industries. The aim of this work was to evaluate and discuss the estimation of uncertainty in pharmaceutical analysis. The uncertainty is a useful tool in the assessment of compliance or non-compliance of in-process and final pharmaceutical products as well as in the assessment of pharmaceutical equivalence and stability study of drug products.

Determination of Harmful Elements and Analysis of Pollution Level in Lysimachia christinae

[Objectives]To detect content of Pb,Cd,Hg,As,Cu,Zn,and Cr in Lysimachia christinae,and to analyze the pollution level.[Methods]Seven kinds of elements in L.christinae were determined by Inductively coupled plasma mass spectrometry and analyzed by single index and comprehensive index.[Results]The seven heavy metal elements showed good linearity in their respective concentration ranges.The recoveries of the samples were 84.5%-109.5%,and the RSD values were 2.30%-5.10%.Comparing the measured results of heavy metal elements with the limit values stipulated in the 2020 edition of the Chinese Pharmacopoeia and other standards,the Cr element in 19 batches of samples exceeded the standard,and the Zn element in 7 batches of samples exceeded the standard.The exceeding rates were 100.0%and 36.8%,respectively;the content of other heavy metal elements did not exceed the standard.The order of individual index from large to small was Cr,Zn,Cd,Hg,Cu,As,and Pb,and the average comprehensive pollution level was mild pollution and above.[Conclusions]L.christinae was mainly polluted by Cr,followed by Zn;this study can provide basic data for drafting of the limit standard for heavy metal elements in L.christinae.

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.

Evaluation of ICUs and weight of quality control indicators:an exploratory study based on Chinese ICU quality data from 2015 to 2020

This study aimed to explore key quality control factors that affected the prognosis of intensive care unit(ICU)patients in Chinese mainland over six years(2015–2020).The data for this study were from 31 provincial and municipal hospitals(3425 hospital ICUs)and included 2110685 ICU patients,for a total of 27607376 ICU hospitalization days.We found that 15 initially established quality control indicators were good predictors of patient prognosis,including percentage of ICU patients out of all inpatients(%),percentage of ICU bed occupancy of total inpatient bed occupancy(%),percentage of all ICU inpatients with an APACHE II score≥15(%),three-hour(surviving sepsis campaign)SSC bundle compliance(%),six-hour SSC bundle compliance(%),rate of microbe detection before antibiotics(%),percentage of drug deep venous thrombosis(DVT)prophylaxis(%),percentage of unplanned endotracheal extubations(%),percentage of patients reintubated within 48 hours(%),unplanned transfers to the ICU(%),48-h ICU readmission rate(%),ventilator associated pneumonia(VAP)(per 1000 ventilator days),catheter related blood stream infection(CRBSI)(per 1000 catheter days),catheter-associated urinary tract infections(CAUTI)(per 1000 catheter days),in-hospital mortality(%).When exploratory factor analysis was applied,the 15 indicators were divided into 6 core elements that varied in weight regarding quality evaluation:nosocomial infection management(21.35%),compliance with the Surviving Sepsis Campaign guidelines(17.97%),ICU resources(17.46%),airway management(15.53%),prevention of deep-vein thrombosis(14.07%),and severity of patient condition(13.61%).Based on the different weights of the core elements associated with the 15 indicators,we developed an integrated quality scoring system defined as F score=21.35%xnosocomial infection management+17.97%xcompliance with SSC guidelines+17.46%×ICU resources+15.53%×airway management+14.07%×DVT prevention+13.61%×severity of patient condition.This evidence-based quality scoring system will help in assessing the key elements of quality management and establish a foundation for further optimization of the quality control indicator system.

Radiotherapy reliability analysis based on PSA method

The reliability of radiotherapy was evaluated and effective approaches were obtained in order to improve radiotherapy quality by using the Probabilistic Safety Assessment(PSA) method. This study investigated the feasibility of the PSA method being applied to radiotherapy through Image-guided Radiotherapy(IGRT) and chest tumor irradiation. A fault tree has been constructed after analyzing causal relationship of the events.After calculating Risk A, a total inaccuracy radiotherapy probability and the importance of all base events were obtained. The probability of inaccurate radiotherapy was 2.87%. Under the condition that the target delineation was perfectly right, the accuracy of radiotherapy significantly improved. With the calculation without Conebeam Computed Tomography(CBCT) being corrected before irradiation, the accuracy significantly decreased.The most important events were connected with the human factor. Improving human technical level could enhance radiotherapy quality control efficiently.

Statistical analysis for genome-wide association study

In the past few years, genome-wide association study （GWAS） has made great successes in identifying genetic susceptibility loci underlying many complex diseases and traits. The findings provide important genetic insights into understanding pathogenesis of diseases. In this paper, we present an overview of widely used approaches and strategies for analysis of GWAS, offered a general consideration to deal with GWAS data. The issues regarding data quality control, population structure, association analysis, multiple comparison and visual presentation of GWAS results are discussed; other advanced topics including the issue of missing heritability, meta-analysis, setbased association analysis, copy number variation analysis and GWAS cohort analysis are also briefly introduced.

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.