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Introduction. The widespread use of heparin preparations for the treatment and prevention of venous thromboembolic complications is known. One of the low molecular weight heparin drugs successfully used in clinical practice is calcium nadroparin. The modern approach to assessing the quality of medicines involves the use of standards, in comparison with which the quality control of the drug is carried out – standard samples (SS). The most important specific parameter in assessing the authenticity of low molecular weight heparins is the characteristic of the fractional composition.Aim. The aim of the work was to develop, attestation and determine the stability during the shelf life of a secondary standard sample to determine the authenticity of calcium nadroparin as part of improving the quality control system of the enterprise with the prospect of creating a domestic pharmacopoeia standard sample.Materials and methods. The object of development and attestation was the standard sample of the enterprise – low molecular weight heparin, obtained on the basis of the Technology implementation center of Siberian state medical university. The certified standard sample was obtained by purification of calcium nadroparin by solid-phase extraction. The completeness of the purification was confirmed by comparing the chromatograms of the purified samples with the chromatograms of the international standard sample. The characteristics of the molecular weight distribution were determined chromatographically. The stability of the certified SSE (the standard sample of the enterprise) was studied under two storage conditions – at a temperature below 8 °C in a dry state for 16 months and in solution at –40 °C for 6 months by evaluating trends in molecular weight distribution.Results and discussion. For each batch of the certified standard sample, the molecular weight and molecular weight characteristics are calculated in 2 parallel definitions, and a representative chromatogram is presented. The values of the relative standard deviation of the molecular weight of the samples and the content of the controlled fractions did not exceed 2.5 %. A detailed analysis of the molecular weight distribution showed the "classical" dependence of RSD (relative standard deviation) from the average value with a significant increase up to 30 % for small fraction values (less than 0.5 %). It was found that during 16 months at a storage temperature below 8 ºC, the molecular weight and molecular weight characteristics of standard samples of low molecular weight heparin did not significantly change. However, in the SSE solution at a storage temperature of minus 40 °C for 6 months, they degraded by more than 10 %.Conclusion. According to the results of the study, a protocol has been developed for obtaining a standard sample of low-molecular-weight heparin for the standardization of the calcium nadroparin substance according to the indicator "molecular weight distribution". The established shelf life of the sample is at least 16 months at temperatures below 8 °C. The stability of solutions of the standard sample at a storage temperature of –40 °C for 3 months is shown.

Quality control of medicines is an integral part of the technological cycle, obligatory for the release of products into public distribution. Both in Russia and abroad, when carrying out of laboratory testing of the preparations, it is prescribed to use the reference materials – the certified standard samples. Currently, it is important for the Russian pharmaceutical industry to provide the methods for evaluating the specific activity of human anti-D immunoglobulin with a national standard sample. Its production is impossible without the production of stabilized concentrate of anti-D antibodies and verifying the suitability of each batch for sale. This requires the establishment of specification requirements and the development of regulatory documentation.Aim is to define the quality criteria for candidate standard for anti-D immunoglobulin.Material and methods. The national and foreign normative bases in the field of quality control of blood products, manufacturing and application of biological standards of medicines were analyzed. Three series of lyophilized concentrate of anti-D antibodies were obtained and a laboratory-experimental study of their properties was carried out.Results and discussion. As a result of the work done, technical specifications were approved, including a list of consumer characteristics, a description of the methods for their assessment and relevant norms.Conclusions. The established requirements can become the basis for the releasing quality control of the candidate standard for anti-D immunoglobulin during its serial production.

The paper presents the results of studying the distribution of effective coercive force (CF) in composite ferromagnetic standard samples assembled from two homogeneous samples with different CF values, abutted to each other. Two types of attachable U-shaped magnetic transducers (MT), which were connected to MA-5 type magnetic analyzer, were used for measurement of effective CF in a closed magnetic circuit. Measurements in an open magnetic circuit were performed using MT of attachable solenoid type, operating by the pole point method (PPM). This MT was connected to a coercimeter-structurescope of IKS-104 type. It is shown that for all MT types the effective CF of composite samples (CS) depends on their position relative to the butt. With MT movement relative to the butt from homogeneous sample with smaller CF to homogeneous sample with larger CF the effective CF increases in the range between CF values of these samples. Quantitatively, the nature of distribution of CS effective CF depends on MT type, its dimensions and type of their orientation relative to the butt for MT of non axisymmetric design. With parallel orientation of the poles of U-shaped MT relative to the butt, the nature of the changes in effective CF is smoother. Presence of a gap between CS parts causes a decrease of effective CF and instability of its values in the butt area. For MT of the same type reduction of their size leads to decrease of effective CF range. For MT of similar size the range of the change in CS effective CF, measured in an open magnetic circuit, is noticeably larger, compared to the one measured in a closed magnetic circuit. Shown is the principal possibility of CS application for metrological support of magnetic structurescopes, as well as for modeling the two-dimensional distribution of CF of ferromagnetic structures, which are characterized by surface inhomogeneity of magnetic parameters. 18 Ref., 1 Tabl., 8 Fig. [ABSTRACT FROM AUTHOR]

As for domestic washing the problem of fabric dye transfer in washing is becoming more and more serious which leads to the decrease of added value of fabrics and affects the aesthetics. With the improvement of people' s living standards the demand for fabrics with high color saturation is increasing day by day. However fabrics with high color saturation are often accompanied by problems such as fabric dye transfer in the washing process which has become a pain point in clothing washing. For this reason washing machines at home and abroad are generally equipped with dye transfer inhibition and color protection washing procedures to alleviate the dye transfer phenomenon caused by mixed washing. Jiangnan University and Wuxi Little Swan Electric Co. Ltd. have carried out a series of studies on the formulation of dye transfer inhibition washing standards and the development of standard samples. In order to realize scientific and objective evaluation of dye transfer inhibition performance and solve the problem of lack of standard samples in washing dye transfer inhibition tests white cloth standard samples and red cloth standard samples for washing dye transfer inhibition tests were prepared to simulate light color clothes and dark color clothes in mixed washing. The color depth and water fastness of the prepared standard color cloth are 0. 2% and grade 3 respectively which comply with the provisions of GB/ T 12490 - 2014 Textiles—Tests for Colour Fastness—Color Fastness to Domestic and Commercial Laundering. The homogeneity of standard white cloth and standard red cloth were tested by variance analysis the short-term stability test and long-term stability test were carried out for the data with an interval of one month and one year respectively by using the stability test formula. For the whiteness and color difference data tested by seven laboratories in order to analyze the normality of the fixed value data it is necessary to conduct a normality test on the obtained data. For this reason the skewness and kurtosis methods are used to conduct a normality test. The indicators tested include the average standard error standard deviation skewness skewness standard deviation kurtosis and kurtosis standard deviation etc. And Cochrane criterion and Dixon criterion are used to judge whether there are outliers. The indicators tested include statistics low-end outliers and high-end outliers. When calculating the uncertainty the uniformity short-term stability long-term stability and uncertainty introduced in the process of setting are calculated respectively to obtain the combined uncertainty. The results show that the standard white cloth and standard colored cloth have good uniformity and high stability. The combined uncertainty of the standard white cloth is 0. 365 8 and the combined uncertainty of the standard color cloth is 0. 358 0. The uncertainty mainly comes from the uncertainty introduced in the process of value determination. The uncertainty introduced by the uniformity short-term stability and long-term stability has little impact. This paper has prepared the standard sample for washing dye transfer inhibition test and provided the standard sample that is missing in the washing dye transfer inhibition test which is expected to realize the objective evaluation of the dye transfer inhibition performance promote the development of the dye transfer inhibition program carried by the washing machine and realize the scientific evaluation of the washing dye transfer inhibition performance. [ABSTRACT FROM AUTHOR]

This article provides insights into qualification testing, interlaboratory comparative testing, and qualification testing programs in testing laboratories that analyze the safety of meat and meat products. Samples with codes OK-MB- 21 were used as a model for interlaboratory comparisons. The uniformity and stability of the CC code was assessed in accordance with GOST R 50779.60-2017 “Statistical methods. Application in proficiency testing through interlaboratory testing ”. Seven laboratories participated in the proficiency testing program. The test preparation procedure was described and the test results determined whether each sample tested was satisfactory or questionable. Participants with unsatisfactory results are encouraged to identify the causes of the alarms, take corrective actions and document them, and identify and eliminate the causes of the unsatisfactory results.

The standard tea samples are indispensable for the objective and accurate identification of tea quality. In this study, the preparation process of standard Hunan black tea standard samples was introduced and its quality was analyzed. The results of the sensory evaluation and biochemical components show that the supper grade of standard Hunan black tea sample had the highest amino acid content, making the taste sweet and mellow. The terpenoid contents in 110 volatile aroma substances identified were significantly higher than those of other tea samples, and the aroma was tender, sweet, rich and lasting. The first grade standard sample had the highest water extracts and catechin content, making the taste mellow. Meanwhile 114 volatile aroma substances were identified, with the contents of various volatile components in the middle level, showing a pure sweet flavor. The second grade standard sample contained relatively low taste component contents, showing sweet with a bit thick taste, and 109 volatile aroma substances were identified. The contents of fatty acid-derived volatile substances and carotenoids were significantly higher than those of other tea samples, showing sweet and floral aroma. This study can provide a reference for the processing and production of Hunan black tea. [ABSTRACT FROM AUTHOR]

In order to solve the problem of deviation in quality grading of Angora rabbit (long-haired rabbit) hair in production, sales, trading and transaction, the national standards GSB 16-3743-2020 " Grading standard sample of Angora rabbit hair-white raw hair" was developed according to GB/T 13832--2009 "Angora rabbit hair". The standard sample complements and perfects GB/T 13832--2009 "Angora rabbit hair", through uniformity analysis, stability analysis, fixed value test and uncertainty analysis and so on, which can be used in the quality classification and grading quality of the rabbit trading of rabbit. The standard sample fills the gaps of Angora rabbit hair standard sample in China for a long time, and provides an important basis for the production, processing, trading and inspection of Angora rabbit hair. [ABSTRACT FROM AUTHOR]

Copyright of Natural Gas Geoscience is the property of Natural Gas Geoscience and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Wide-angle X-ray scattering (WAXS) is routinely used to characterize the ordered structure in materials. The measured angles are generally calibrated by using standard samples with several diffraction peaks. When a WAXS instrument uses a one-dimensional linear detector, which is tilted to the direct beam, the angle calibrations need three standard diffraction peaks. This contribution presents the corresponding analytical solution of the calibration equations and error estimation matrix and performs error simulation and experimental verification. The results show that the selected three standard diffraction peaks should uniformly span and widely cover the detector to reduce the error of angle calibration. [ABSTRACT FROM AUTHOR]

Results are presented from a metrological study of the field of the experimental channel of the OR research reactor (an experimental facility at the NRC Kurchatov Institute) with a power of 0.1–300 kW. Empirical dependences are obtained for the contribution of the absorbed dose of gamma radiation to the absorbed dose rate over the entire irradiation time as the OR reactor power is raised and lowered in the steady state. Based on these results, a preliminary calculation can be made of the absorbed dose and absorbed dose rate of the gamma radiation. The experimental channel of the OR reactor was certified on the basis of the metrological studies in terms of the absorbed dose rate of gamma radiation as a specialized source of gamma radiation combined spatially with a model reference neutron field in this channel. The specialized source is intended for calibration of special-purpose measurement instrumentation and for testing the radiation resistance of products operating in the mixed gamma-neutron radiation fields of nuclear reactors. [ABSTRACT FROM AUTHOR]

We have built the XAFS Standard Sample Database, which collects XAFS spectral data of standard samples measured at BL14B2 in SPring-8 and classifies them systematically (element, absorption edge, and lattice plane). The database contains XAFS spectral data of 36 elements, 720 samples, and 1604 experimental spectra (as of 10.1.2022). All of the standard samples registered in the database were commercial reagents for which product information such as purity, composition, and lot number can be obtained. Samples unstable in air, such as deliquescent and hygroscopic ones, were prepared in a glove box and sealed in a gas barrier bag or aluminum laminated bag. XAFS measurements for the standard samples were conducted in the transmission mode at BL14B2 in SPring-8. The XAFS spectra were checked by comparing them with those of other samples, those reported in past papers, and those measured at other Japanese XAFS facilities. The database was developed by the data transfer system BENTEN. The database can be used by anyone with an authentication on a personal email address. The database can be used not only for reference data to analyze XAFS spectra of unknown samples but also for the preliminary examination of XAFS measurements and comparison with data in other facilities. • We have built the XAFS Standard Sample Database. • All standard samples are commercially available reagents. • Spectral data align monochromator angle scales basically. • Data license is "Creative Commons Attribution-NonCommercial-ShareAlike". [ABSTRACT FROM AUTHOR]

Authenticity evaluation of proteins obtained with recombinant DNA technology is an important step in confirming efficacy and safety of the drugs based on them. One of the main ways to assess the authenticity is to compare molecular structure of the test and standard samples using the peptide mapping method with chromatographic separation of the products obtained by enzymatic degradation. Proper selection of a standard reference sample is essential in order to achieve reliable results. A standard sample of Interferon (CRS, Chemical Reference Substances) recommended by the European Agency for the Quality of Medicines for interferon alpha-2b substances containing N-terminal methionine is inappropriate, since the Interferon CRS sample doesn’t contain methionine. We present the results of development of qualification procedure for methionine form of Interferon alfa-2b industrial standard sample (ISS). The range of use for this ISS is authenticity confirmation for the methionine form of interferon alpha-2b substance using peptide mapping method with reverse-phase high-performance liquid chromatography (reverse-phase HPLC). The quality assessment was performed for all the parameters specified by the manufacturer of this candidate substance at the initial stage of qualification procedure, due to changed application area, and changed package size. Further, 30 peptide cards of the ISS candidate substance were obtained after pre-trypsinolysis of the protein followed by validated HPLC method with proven repeatability.It was shown that the hydrolysis conditions, i.e., the choice of trypsin preparations, may significantly affect the peptide map profile. Therefore, a reference to specific manufacturer and the catalog number of the product should be provided in description of application conditions for the ISS proposed.A set of eight reference peaks (peaks of comparison) has been justified, as based on evaluation of peptide maps and results of high-resolution mass spectrometry. The peak with maximally stable yield and intensity was selected as the main peak with an established absolute retention time. Two peaks with relative retention times were chosen as essential peaks for evaluation, i.e., the 1st peak containing N-terminal methionine, and the 2nd peak of highest molecular weight with an established amino acid sequence covering 11% of the studied interferon molecule.We have also qualified ISS parameters expressed as absolute (minimum for one reference peak), and relative (for the remaining reference peaks) retention time periods. Authenticity of the ISS candidate was further confirmed by the peptide mapping method, as compared with interferon CRS reference standard. Their peak patterns proved to be near-similar, except of a peak with eluted peptide containing N-terminal methionine as revealed by high-resolution mass spectrometry

Abstract—The widespread introduction of polymer composite materials (PCMs) into aviation technology has led to the search and selection of effective methods for nondestructive testing of aircraft structure elements. According to the operating data, one of the main types of accidental damage to aviation equipment is shock effects. Therefore, the problems of detecting such damage to PCM products using thermal nondestructive testing as a promising method and identifying the features of this approach are relevant. In this work, the authors carried out tests on standard samples of materials, structurally similar samples, and the elements of a full-scale aircraft construction. The results of thermal imaging surveys of impact damage to PCM products were analyzed with standard and dedicated software after testing. Suggestions recommended for further research and practical use are formulated. [ABSTRACT FROM AUTHOR]

Materials for the development and certification of a standard sample for anti-D antibody contents in human immunoglobulin drugs are presented. Preparation of the negative component of the standard sample from blood plasma of Rh-positive group IV(AB) donors without anti-D antibodies; the positive component, from blood plasma of Rh-negative group IV(AB) donors is justified. The immunoglobulin should be concentrated to produce a solution with protein contents in the range 48 – 51 mg/mL and anti-D antibody titer 1:8. Flow cytofluorimetry is shown to allow standardization of the preparation of the standard sample positive component. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Food Safety & Quality is the property of Journal of Food Safety & Quality Editorial Department and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Molybdenum trioxide (MoO3) has been studied by four thermal analysis techniques. The as-synthesized material has hexagonal structure (h-MoO3). The phase change in the material studied using four thermal analysis techniques: thermogravimetric analysis, differential scanning calorimetry (DSC), thermomechanical analysis, and dynamic mechanical analysis. Crystallography phase transformation of h-MoO3 was found between 675 and 701 K by these techniques. DSC technique provided the highest detection sensitivity at about 690 K since the metastable monoclinic phase (β-MoO3) transformation could be observed before reaching the stable orthorhombic (α-MoO3) phase. The crystallographic phases of particles and morphologies were confirmed by X-ray diffraction and scanning electron microscopy techniques. The h-MoO3 was proposed as a standard sample to validate the operations of the thermal analysis instruments. [ABSTRACT FROM AUTHOR]

Randomly collected food waste results in inaccurate experimental data with poor reproducibility for composting. This study investigated standard food waste samples as replacements for randomly collected food waste. A response surface methodology was utilised to analyse data from a 28-day compost process optimisation experiment using collected food waste, and the optimal combination of composting parameters was derived. Experiments using different standard food waste samples (high oil and salt, high oil and sugar, balanced diet, and vegetarian) were conducted for 28 days under optimal conditions. The ranking of differences between the standard samples and collected food waste was vegetarian > balanced diet > high oil and sugar > high oil and salt. Statistical analysis indicated t -tests for increased oil and salt samples and collected food waste were not significant, and Cohen's d effect values were minimal. High oil and salt samples can be used as replacements for collected food waste in composting experiments. [Display omitted] • Studied standard samples as replacements for random food waste in composting. • Process optimisation experiment determined optimal composting parameter combination. • Statistical data showed high oil and salt standard sample can substitute food waste. • Standardized samples improve reproducibility of food waste composting. [ABSTRACT FROM AUTHOR]

In spite of the vast arsenal of therapeutic agents, therapy of herpes virus infection (HVI) is very difficult, particularly in pregnant women, newborns and children in the first years of life, as well as in patients with immune deficiency. In this regard, possibility of using immunoglobulins for the treatment of HVI is currently attracting the attention of doctors. The aim of this work was to develop a suppository form of the drug containing donor immunoglobulins with high levels of neutralizing antibodies to herpes simplex virus types 1 and 2 for the treatment of chronic forms of herpetic disease. The study included the following steps: 1) selection of gamma-globulins with high antibody titer for HSV-1 and HSV-2 ELISA test; 2) determination of the level of neutralizing antibodies in the selected series of gamma-globulins in tests in tissue cultures and animals; 3) lyophilization of immunoglobulins; 4) development of the suppository form of the preparation containing gamma-globulin donors with high levels of neutralizing antibodies to HSV-1 and HSV-2; 5) study of the safety of the activity of neutralizing antibodies to HSV-1 and HSV-2 in the suppository form of the drug with hyaluronic acid used as immunomodulator. As the result of this work, immunoglobulin preparation in the suppository form was developed. The developed preparation meets the requirements for safety and efficacy. It is not toxic or pyrogenic. The problems of clinical use of this drug as a method of HVI therapy are discussed.

Copyright of Technical Diagnostics & Nondestructive Testing / Tekhnicheskaya Diagnostika I Nerazrushayushchiy Kontrol is the property of International Association Welding (Paton Publishing House) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Due to the specific character of problems in the field of ionizing radiation spectroscopy, the R&D and making process of standard volumetric activity metal samples (standard samples) for calibration and verification of spectrometric equipment is not only expensive, but also requires the use of highly qualified experts and a unique specific equipment. Theoretical and experimental studies performed have shown the possibility to use imitators as a set of alternating point sources of gamma radiation and metal plates and their use along with standard volumetric activity metal samples for calibration of scintillation-based detectors used in radiation control in metallurgy. Response functions or instrumental spectra of such spectrometer to radionuclides like 137Cs, 134Cs, 152Eu, 154Eu, 60Co, 54Mn, 232Th, 226Ra, 65Zn, 125Sb+125mTe, 106Ru+106Rh, 94Nb, 110mAg, 233U, 234U, 235U and 238U are required for calibration in a given measurement geometry. Standard samples in the form of a probe made of melt metal of a certain diameter and height are used in such measurements. However, the production of reference materials is costly and even problematic for such radionuclides as 94Nb, 125Sb+125mTe, 234U, 235U etc. A recognized solution to solve this problem is to use the Monte-Carlo simulation method. Instrumental experimental and theoretical spectra obtained by using standard samples and their imitators show a high compliance between experimental spectra of real samples and the theoretical ones of their Monte-Carlo models, between spectra of real samples and the ones of their imitators and finally, between experimental spectra of real sample imitators and the theoretical ones of their Monte-Carlo models. They also have shown the adequacy and consistency of the approach in using a combination of metal scattering layers and reference point gamma-ray sources instead of standard volumetric activity metal samples. As for using several reference point gamma-ray sources with radionuclide like 152Eu, 232Th, 226Ra etc, they allow, in a combination of metal scattering layers, to compensate for the absorption of low energy gamma rays in the metal and to generate the desired response in the backscatter peak range, and finally to get the correct amplitude distribution that is equivalent to interaction effects that occur in the volumetric standard sample with radionuclide uniformly distributed in it.

Documentation for standardization of the method for determining hemagglutinins (HAs) in human immunoglobulin preparations used in Russia is presented. The proposed general pharmacopoeial monograph “Determination of anti-A and anti-B hemagglutinins in medicinal preparations of human immunoglobulin” allows quality control of human immunoglobulin preparations for HAcontent using indirect hemagglutination under standard conditions. The positive and negative components of the domestic standard sample (SS) of HAs contain 1:32 anti-A and 1:16 anti-B, respectively; less than 1:2 anti-A and -B; and 1:64 components of the HA content limit. Introduction of the SS for contents of anti-A and anti-B HAs into pharmacopoeial practice would ensure that results obtained in various ranges are accurate and enable the quantitative contents of the corresponding HAs in human immunoglobulin preparations to be determined. [ABSTRACT FROM AUTHOR]

Infrared (IR) p-polarized multiple-angle incidence resolution spectrometry (pMAIRS) is a useful spectroscopic tool for revealing the molecular anisotropic structure in a thin film, which is used for the molecular orientation analysis of many functionalized organic thin films. Infrared pMAIRS provides both in-plane (IP) and out-of-plane (OP) vibrational mode spectra, which are influenced by the choice of the angles of incidence, i.e., angle set. To obtain quantitatively reliable pMAIRS spectra, therefore, the optimal angle set must be revealed. In a former study, an optimization study was carried out on a silicon substrate by using the band intensity ratio of the IP and OP spectra of highly oriented molecules in a thin film, which has a problem that the optimized results cannot be used for another substrate. In the present study, a totally new idea using an optically isotropic thin film as a standard sample is proposed to comprehensively explore the optimal angle set on various substrates: the band shift due to the Berreman effect of a strongly absorbing compound is used, instead of the band intensity. This new approach makes the pMAIRS calibration for various substrates a much easier task. With the optimal angle set, the molecular orientation angle in the film calculated by the pMAIRS spectra is also found to be reliable quantitatively. This technique opens a user-friendly way to a reliable molecular orientation analysis in an ultrathin film using IR pMAIRS. [ABSTRACT FROM AUTHOR]

An evaluation and stability study of the original Russian human immunoglobulin standard intended for determining the anticomplementary activity and assessing the stability and acceptability of test results are reported. The certified values of the experimental anticomplementary activity of the negative control standard fell in the range 37.9 - 45.1%; of the positive control, 73.6 - 82.8% (for P = 0.95). Ashelf life of 1.5 years was justified based on the stability data of the standard sample. Introduction of the certified reference materials into the analysis of human immunoglobulin pharmaceutical preparation for intravenous administration during evaluation and quality control under government projects and confirmation of compliance with regulatory requirements will ensure that the determined anticomplementary properties are accurate. [ABSTRACT FROM AUTHOR]