Certification of Pharmaceutical Substances as In-House Primary Standards (Review)

Author(s):  
N. A. Epshtein
2020 ◽  
pp. 22-29
Author(s):  
A. Bogoyavlenskiy ◽  
A. Bokov

The article contains the results of the metrological examination and research of the accuracy indicators of a method for diagnosing aircraft gas turbine engines of the D30KU/KP family using an ultra-high-frequency plasma complex. The results of metrological examination of a complete set of regulatory documents related to the diagnostic methodology, and an analysis of the state of metrological support are provided as well. During the metrological examination, the traceability of a measuring instrument (diagnostics) – an ultrahigh-frequency plasma complex – is evaluated based on the scintillation analyzer SAM-DT-01–2. To achieve that, local verification schemes from the state primary standards of the corresponding types of measurements were built. The implementation of measures to eliminate inconsistencies identified during metrological examination allows to reduce to an acceptable level the metrological risks of adverse situations when carrying out aviation activities in industry and air transportation. In addition, the probability of occurrence of errors of the first and second kind in the technological processes of tribodiagnostics of aviation gas turbine engines is reduced when implementing a method that has passed metrological examination in real practice. At the same time, the error in determining ratings and wear indicators provides acceptable accuracy indicators and sufficient reliability in assessing the technical condition of friction units of the D-30KP/KP2/KU/KU-154 aircraft engines.


2021 ◽  
Vol 22 (12) ◽  
pp. 6283
Author(s):  
Jérémy Lamarche ◽  
Luisa Ronga ◽  
Joanna Szpunar ◽  
Ryszard Lobinski

Selenoprotein P (SELENOP) is an emerging marker of the nutritional status of selenium and of various diseases, however, its chemical characteristics still need to be investigated and methods for its accurate quantitation improved. SELENOP is unique among selenoproteins, as it contains multiple genetically encoded SeCys residues, whereas all the other characterized selenoproteins contain just one. SELENOP occurs in the form of multiple isoforms, truncated species and post-translationally modified variants which are relatively poorly characterized. The accurate quantification of SELENOP is contingent on the availability of specific primary standards and reference methods. Before recombinant SELENOP becomes available to be used as a primary standard, careful investigation of the characteristics of the SELENOP measured by electrospray MS and strict control of the recoveries at the various steps of the analytical procedures are strongly recommended. This review critically discusses the state-of-the-art of analytical approaches to the characterization and quantification of SELENOP. While immunoassays remain the standard for the determination of human and animal health status, because of their speed and simplicity, mass spectrometry techniques offer many attractive and complementary features that are highlighted and critically evaluated.


Membranes ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 481
Author(s):  
Daniel Polak ◽  
Izabela Zielińska ◽  
Maciej Szwast ◽  
Igor Kogut ◽  
Artur Małolepszy

The aim of this work is to develop a new type of carbon-ceramic membranes for the removal of pharmaceutical substances from water. The membranes were prepared by the chemical modification method using an organosilicon precursor—octadecyltrichlorosilane (ODTS). Graphene oxide, multi-walled carbon nanotubes with carboxylic groups, and single-walled carbon nanotubes were used in the modification process. The filtration properties and adsorption properties of the developed membranes were tested. In order to characterize the membrane, the water permeability, the change of the permeate flux in time, and the adsorbed mass of the substance were determined. Additionally, the surface properties of the membranes were characterized by contact angle measurements and porosimetry. The antibiotic tetracycline was used in the adsorption tests. Based on the results, the improved adsorption properties of the modified membrane in relation to the unmodified membrane were noticed. Novel ceramic membranes modified with MWCNT are characterized by 45.4% removal of tetracycline and permeate flux of 520 L·h·m−2·bar−1. We demonstrated the ability of modified membranes to adsorb pharmaceuticals from water streams that are in contact with the membrane. Novel membranes retain their filtration properties. Therefore, such membranes can be used in an integrated filtration–adsorption process.


Author(s):  
K. Hohlfeld ◽  
P. Andreo ◽  
O. Mattsson ◽  
J. P. Simoen

This report examines the methods by which absorbed dose to water can be determined for photon radiations with maximum energies from approximately 1 MeV to 50 MeV, the beam qualities most commonly used for radiation therapy. The report is primarily concerned with methods of measurement for photon radiation, but many aspects are also relevant to the dosimetry of other therapeutic beams (high-energy electrons, protons, etc.). It deals with methods that are sufficiently precise and well established to be incorporated into the dosimetric measurement chain as primary standards (i.e., methods based on ionisation, radiation-induced chemical changes, and calorimetry using either graphite or water). The report discusses the primary dose standards used in several national standards laboratories and reviews the international comparisons that have been made. The report also describes the reference conditions that are suitable for establishing primary standards and provides a formalism for determining absorbed dose, including a discussion of correction factors needed under conditions other than those used to calibrate an instrument at the standards laboratory.


2021 ◽  
Author(s):  
Wesley Odom ◽  

The laboratory notebook is the fundamental record for research and development. The emergence of cloud-based digital tools to replace or augment the laboratory notebook has shown promise for groups that are multidisciplinary, working asynchronously, or in multiple locations. This paper details a recent pilot study conducted by Sandia National Laboratories (SNL) comparing an electronic lab notebook (ELN) with traditional paper lab notebooks (PLN), including members of SNL’s Primary Standards Laboratory (PSL). Partly motivated by a related pilot study conducted at the National Institute of Standards and Technology (NIST), the focus of the present study was on the integrability of an ELN within the unique constraints of a national lab, including security protocols that limit cloud capabilities and limited WIFI. The study used Microsoft OneNote and commercially available mobile computing hardware. The pilot included 18 participants from the PSL, biosciences, and materials science/engineering labs. In addition to OneNote, participants were provided one of two options for a computer to be used as their note taking device (including a stylus). Usability and gap analyses, as well as interviews with pilot participants were conducted by members from Sandia’s human factors group. Findings from this study indicate that ELNs may be particularly useful for teams where sharing of procedures and results is important. Participants believed that use of the ELN increased organization of their work and facilitated reporting much more than paper lab notebooks (PLNs). Other benefits included searchability and capability for access on multiple devices. Many of the identified drawbacks were specific to the unique constraints of working at a national lab, but some constraints are more general (e.g. use of ELNs in wet labs where hazardous materials may be of concern). Overall, it was found with proper training, collaboration on best practices, and technical support, that ELNs appear to be a promising tool for modernizing recording practices in research. Some examples from PSL will be highlighted, including R&D for qualifying measurement systems, calibration processes, and procedures.


2020 ◽  
pp. 1-20
Author(s):  
E.M. Costa-Neto ◽  
N.T. Grabowski

Like insects, arachnids (spiders, scorpions, mites and ticks) and myriapods (millipedes and centipedes) also have a history of traditional consumption, either as foodstuff or medicine. In this review, an updated list of edible arachnids and myriapods is presented, showing that these animals are consumed worldwide. They are collected from the wild, and typical processing includes heating, defanging and, in certain cases, drying and grinding. The scarce data show a marked variation in nutrient composition that depends on the taxon and even sex, possibly also instar and feeding. Evaluating these traditions in terms of food safety, tick consumption must be discouraged, and heating steps are mandatory to eliminate pathogens, venoms, and urticating setae. For the future, more research will be necessary to assess chemical risks in wild-caught animals in terms of consumer safety and to get productive arachnid and myriapod farming for foodstuffs and industrial uses (pharmaceutical substances and silks) started.


Sign in / Sign up

Export Citation Format

Share Document