Accreditation and Quality Assurance最新文献

Reference material is of great significance to the measurement accuracy of X-ray energy/wave dispersive spectrometer (EDS/WDS). In this work a reference material of manganese (Mn) content (mass fraction, %) of pure Mn flake for EDS/WDS calibration was developed. The surfaces of Mn flakes were finely treated by mechanical grinding and argon ion polishing, and the Mn flakes with high cleanliness and low roughness were obtained. The homogeneity and stability of Mn content of the Mn flakes were analyzed carefully using electron probe micro-analyzer (EPMA). The Mn content of the reference material was determined using inductively coupled plasma optical emission spectrometer (ICP-OES) and inductively coupled plasma mass spectrometry (ICP-MS). The sources of uncertainty components of Mn reference material were fully analyzed and evaluated. The results show that the homogeneity of the pure Mn flake reference material meet the requirements. The Mn content of the vacuum-packed pure Mn flake is stable for up to one year at ambient temperature. The Mn content reference material of the pure Mn flake reference material is 99.5 %, and its expanded uncertainty is 0.9 % (k = 2). The pure Mn flake reference material can meet the calibration requirements of X-ray EDS/WDS, and guarantee the accuracy and consistency of measurement results. The content of this study complies with the definition of reference materials in ISO 17034 and can be used to calibrate measurement systems. The Mn content reference material can be widely used for element measurement in the fields of scientific research, manufacturing and trade activities.

Graphical abstract

A QbD stability-indicating RP-HPLC method for posaconazole and its related substances from API’s was developed and validated. Separation was accomplished by using Box–Behnken design by varying volume of acetonitrile, pH, and flow rate. Chromatographic separation was achieved on a Zorbax SB C18 column (4.6 mm × 5.0 μm) using an gradient program consists of mobile phase A phosphate buffer and mobile phase B acetonitrile and water in the ratio (80:20 %v/v) at a flow rate of 0.8 mL/min on a waters HPLC system. At 260 nm, posaconazole was monitored and impurities were also detected. Acid/base hydrolysis, oxidation, photolysis, and thermal degradation, all performed stress testing that was shown to have major breakdown, per ICH guidelines. The method achieved a resolution greater than 2.0 between posaconazole and its degradants, with a correlation coefficient (r²) of 0.999 indicating excellent linearity. Its accuracy, precision, linearity, and robustness were all validated.

Saxagliptin (Onglyza) is an inhibitor of dipeptidyl peptidase-4 (DPP-4) type 2 diabetes can be treated with this drug. Unremitting diabetes is characterized by elevated blood sugar levels. Saxagliptin is one example of an antidiabetic medication that lowers blood glucose levels. The compound saxagliptin have been distinguished and measured by the utilize of analytical and bioanalytical methods including reverse phase high performance, ultrahigh performance chromatographic, and spectroscopic approaches. Assessment of the pharmacokinetic characteristics, bioavailability, and metabolism of this antidiabetic pharmaceutical in biological matrices has too profited significantly from the application of bioanalytical approaches. The recognizable proof and evaluation of saxagliptin was affirmed through the utilize of analytical and bioanalytical methods, such as HPLC, HPTLC, UPLC, RP-HPLC, UV spectroscopy, UV–VIS spectroscopy, capillary electrophoresis, LC/MS, RP-LC-PDA, UPLC-MS, UHPLC, LC–ESI–MS, RPHPLC-UV, LC–MS/MS, HILIC-MS, SPE-LC-UV. An outline of the characteristics and traits of antidiabetic medicine saxagliptin is displayed in this work, in conjunction with the analytical and bioanalytical strategies utilized to distinguish and evaluate them.

Rosa laevigata Michx., a traditional medicinal and edible plant in China, has been widely used for its health-promoting properties. This study aimed to develop a rapid and reliable analytical method for the simultaneous determination of eight bioactive triterpenoids in R. laevigata fruits and to explore their potential as functional food and pharmaceutical ingredients for the prevention of neurodegenerative diseases. Systematic optimization of HPLC conditions enabled quantitative analysis of triterpenoids within 40 min, exhibiting excellent linearity, precision, stability, and reproducibility. Network pharmacology identified TNF and PPARG as the top two targets and revealed that 2α, 3α, 19α, 23-tetrahydroxyurs-12-en-28-oic acid exhibited multi-target affinity. Molecular docking and dynamics simulations further validated the stability of its binding with the target proteins. In vitro neuroprotection assays confirmed that 2α, 3α, 19α, 23-tetrahydroxyurs-12-en-28-oic acid significantly reversed H₂O₂-induced viability impairment in SH-SY5Y cells in a dose-dependent manner, consistent with predictions. This study not only provides a theoretical foundation for optimizing functional food and pharmaceutical formulations, but also highlights the potential of its natural components in neurodegenerative disease intervention through mechanistic exploration.

This short descriptive piece examines the evolving landscape of border control quality assurance through the lens of Lox company's operations at the Parwezkhan crossing between Iraq and Iran. We highlight how private quality control companies navigate economic constraints, infrastructural limitations, and regulatory challenges while maintaining international standards. This article explores insights gained from the implementation of advanced molecular detection technologies by Lox company, in collaboration with the Iraqi Central Organization for Standardization and Quality Control (COSQC). It highlights the role of effective public–private partnerships in enhancing border quality control processes. By examining these collaborations, the study advocates for the integration of technological innovation, strengthened institutional partnerships, and enhanced regulatory transparency as critical measures to improve the efficiency and reliability of quality control systems at border regions. Additionally, the article addresses key challenges in food safety and risk management within the context of border control operations. This study illuminates the significant research gap regarding food testing protocols at Iraqi borders, where limited empirical data exists on cross-border food safety assessment.

This study compares the Algorithm A and Q/Hampel methods outlined in ISO 13528, and the NDA method utilized within the WEPAL/Quasimeme PT schemes, as far as robustness to outliers is concerned. The comparison starts with an analysis of Empirical Influence Functions. This analysis shows that NDA applies the strongest down-weighting to outliers, followed by Q/Hampel and Algorithm A, respectively. Second, we evaluated the methods using simulated datasets.. Stylized datasets using a normal distribution N(1,1) with 30 and 200 data were contaminated with 5%-45% data drawn from 32 different distributions. NDA consistently produced mean estimates closest to the true values, while Algorithm A showed the largest deviations. The percentage differences between the mean estimates of Q/Hampel and Algorithm A relative to NDA turned out to be linearly proportional to the L-skewness of the dataset within a substantial interval around L-skewness = 0. Third, the relationship between percentual differences between the mean estimates and L-skewness was analysed for over 33,000 datasets from WEPAL/Quasimeme. The linear relationships observed in the simulation study were reproduced. The percentual differences between the mean estimates were projected onto L-moment diagrams, stratified by sample size. Across the four classes discerned, the results exhibit consistent and interpretable patterns. The three methods showed similar robustness to tail weight (L-kurtosis), but NDA was markedly more robust to asymmetry, particularly in smaller samples. The three methods yield estimates that differ by less than 2% when L-skewness approaches zero. The findings demonstrate that NDA has a higher robustness than Q/Hampel and Algorithm A. NDA exhibits a lower efficiency (~ 78%) compared to Q/Hampel and Algorithm A (both ~ 96%). Our analysis clearly shows the robustness versus efficiency trade-off that is typical for this kind of statistical methods. We recommend PT organizers to assess this trade-off in the light of the distributional characteristics of their datasets and, if necessary, adapt the selection or parametrization of the statistical methodology. For the WEPAL-Quasimeme scheme, the emphasis put by the NDA method on robustness is an advantage given the characteristics of the datasets usually analysed in this scheme. In addition to mean estimation, our study also evaluates the behaviour of the standard deviation of the estimates generated by Q_n, Q/Hampel, Algorithm A, and NDA. Q_n and Q/Hampel produced similar results in datasets with larger sample sizes (N > 16). Q/Hampel produced higher estimates in smaller datasets. Algorithm A provided estimates consistent with the other methods for near-Gaussian datasets, but higher estimates for higher contamination levels. NDA’s standard deviation estimates were generally in agreement with those of Q/Hampel and Q_n, but consistently lower for leptokurtic distributions. This behaviour is a