scholarly journals Importance of a High Performing GC-MS Based Screening Method for Testing Stability Samples for Volatile and Semi-Volatile Leachable Impurities

2021 ◽  
Vol 3 (1) ◽  
pp. 3-20
Author(s):  
Gyorgy Vas ◽  
Louis Fleck ◽  
Anna Michelson ◽  
Nicole Dunn ◽  
John Duett ◽  
...  
Keyword(s):  
High Performance ◽  
Screening Method ◽  
Correlation Study ◽  
Pharmaceutical Products ◽  
Screening Methods ◽  
Mass Detection ◽  
Trace Level ◽  
High Performing ◽  
Targeted Screening ◽  
High Level

Leachable testing for finished pharmaceutical products is an important part of the regulatory filing and is under more regulatory scrutiny than ever before. Leachable testing for multiple finished drug products such as biologics, large volume parenterals, and polymer-based finished products requires analysis at trace levels with a high level of confidence. A high level of analytical expertise and top-of-the-line analytical instrumentation is required for work at trace levels. (The definition of trace level analytical testing has not been accurately defined; however, to have a sense of the “trace-level”-associated testing issues, we are arbitrarily assigning levels below 100 ng/mL as trace level and below 1 ng/mL as ultra-trace level in this paper). Leachable testing ideally should be performed on a targeted list of analytes compiled from an extractable study and an extractable and leachable correlation study, along with a general non-targeted screening evaluation to avoid any undetected leachables. For targeted screening, analytical testing is more straightforward and can typically detect targets at ppb or sub-ppb levels without issue. However, for a general screening method, this can be difficult, and many times requires special sample preparation combined with high-resolution accurate-mass detection. Case studies will be presented to demonstrate the importance of high-performance and highly sensitive screening methods in detecting unexpected leachables, and in supporting related quality investigations. The importance of well-designed and executed system suitability will also be discussed in this paper.

scholarly journals Розробка та оцінка придатності методу з визначення антибіотиків у молоці за допомогою рідинної хроматографії високого тиску - тандемної мас-спектрометрії (UPLC-MS-MS)

2017 ◽  
Vol 7 (4) ◽  
pp. 569-575
Author(s):  
O. V. Bayer ◽  
O. S. Yaremchuk ◽  
L. V. Shevchenko ◽  
V. M. Mykhalska
Keyword(s):  
High Performance ◽  
Screening Method ◽  
Penicillin G ◽  
Screening Methods ◽  
The European Union ◽  
Chromatography Tandem Mass Spectrometry ◽  
Council Directive ◽  
Residual Amount ◽  
Liquid Chromatography Tandem Mass

<p>On the basis of the conducted research, validation of the method for the determination of sulfonamides and antibiotics in milk by screening method was developed and conducted by LC / MS / MS. It has been confirmed that a method determination by ultra-high-performance liquid chromatography–tandem mass spectrometry (UPLC / MS / MS) is more sensitive and selective. Validation of the method was carried out in accordance with the Decision of the European Commission 2002/657 / EC of 12 August 2002, which ensures the implementation of Council Directive 96/23 / EC concerning the effectiveness of analytical methods and the interpretation of results, and in accordance with the recommendations of the reference laboratories of the European Union CRLs of 20/1/2010 on the assessment of the suitability of screening methods for the determination of veterinary drugs. It is proved that the adapted method for the determination of sulfonamides and antibiotics is sensitive and according to parameters meets the European requirements. This method is fast enough, practical and universal, since it allows simultaneous examination of about 70 antibacterial drugs at the same time in milk.</p><p>It has been established that the method of determining the residual amount of sulfonamides and antibiotics by the UPLC / MS / MS is suitable for the investigation of milk on the content of the following drugs: sulfaguanidine, sulfacetamide, sulfapiridine, sulfadiazine, sulfamethoxazole, sulfathiazole, sulfamethazine, sulfamethizole, sulfabenzamide, sulfaquinoxaline, sulfadoxine, sulfadimetoxin, sulfanilamide, trimethoprim, sulfamonomethoxine, sulfamethoxypyridazine, sulfachlorpyridazine, sulfamoxol, dapsone, amoxicillin, ampicillin, penicillin G, penicillin V, oxacillin, cloxacillin, nafcillin, dicloxacillin, cefalonium, cefazolin, cefoperazon, cefquinome, cefapirin, ceftiofur, cefalexin, norfloxacin, enrofloxacin, ciprofloxacin, marbofloxacin, difloxacin, danofloxacin, sarafloxacin, flumekvin, oxolinic acid, nalidixic acid, oxytetracycline, chlortetracycline, tetracycline, doxycycline, epi-oxytetracycline, epi-tetracycline, epi-chlortetracycline, streptomycin, dihydrostreptomycin, gentamicin, kanamycin, apramycin, paromomycin, lincomycin, spectinomycin, tilmycosin, erythromycin, josamycin, spiramycin, tylosin, tiamulin, colistin, gamitromycin, tulatromycin. In assessing the suitability of the method, the MS / MS detection parameters are set and the validation characteristics are determined.</p>

What Can Digitization Do For Formulated Product Innovation and Development

2020 ◽  
Author(s):  
James McDonagh ◽  
William Swope ◽  
Richard L. Anderson ◽  
Michael Johnston ◽  
David J. Bray
Keyword(s):  
High Performance ◽  
Quality Data ◽  
High Quality Data ◽  
Base Level ◽  
Hybrid Approaches ◽  
Digital Ecosystem ◽  
Recent Developments ◽  
Chemical Simulation ◽  
High Level ◽  
Physical And Chemical

Digitization offers significant opportunities for the formulated product industry to transform the way it works and develop new methods of business. R&D is one area of operation that is challenging to take advantage of these technologies due to its high level of domain specialisation and creativity but the benefits could be significant. Recent developments of base level technologies such as artificial intelligence (AI)/machine learning (ML), robotics and high performance computing (HPC), to name a few, present disruptive and transformative technologies which could offer new insights, discovery methods and enhanced chemical control when combined in a digital ecosystem of connectivity, distributive services and decentralisation. At the fundamental level, research in these technologies has shown that new physical and chemical insights can be gained, which in turn can augment experimental R&D approaches through physics-based chemical simulation, data driven models and hybrid approaches. In all of these cases, high quality data is required to build and validate models in addition to the skills and expertise to exploit such methods. In this article we give an overview of some of the digital technology demonstrators we have developed for formulated product R&D. We discuss the challenges in building and deploying these demonstrators.<br>

https://imsciences.edu.pk/files/journals/vol12_2/New%201%20MA.864.pdf

2020 ◽  
Vol 12 (2) ◽  
pp. 19-50 ◽  
Author(s):  
Muhammad Siddique ◽  
Shandana Shoaib ◽  
Zahoor Jan
Keyword(s):  
Organizational Performance ◽  
Structural Equation ◽  
High Performance ◽  
Service Sector ◽  
Performance Outcomes ◽  
Theory And Practice ◽  
Relational Coordination ◽  
Multiple Sources ◽  
And Performance ◽  
High Level

A key aspect of work processes in service sector firms is the interconnection between tasks and performance. Relational coordination can play an important role in addressing the issues of coordinating organizational activities due to high level of interdependence complexity in service sector firms. Research has primarily supported the aspect that well devised high performance work systems (HPWS) can intensify organizational performance. There is a growing debate, however, with regard to understanding the “mechanism” linking HPWS and performance outcomes. Using relational coordination theory, this study examines a model that examine the effects of subsets of HPWS, such as motivation, skills and opportunity enhancing HR practices on relational coordination among employees working in reciprocal interdependent job settings. Data were gathered from multiple sources including managers and employees at individual, functional and unit levels to know their understanding in relation to HPWS and relational coordination (RC) in 218 bank branches in Pakistan. Data analysis via structural equation modelling, results suggest that HPWS predicted RC among officers at the unit level. The findings of the study have contributions to both, theory and practice.

scholarly journals SERS Biosensor Based on Engineered 2D-Aperiodic Nanostructure for In-Situ Detection of Viable Brucella Bacterium in Complex Matrix

Nanomaterials ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. 886
Author(s):  
Massimo Rippa ◽  
Riccardo Castagna ◽  
Domenico Sagnelli ◽  
Ambra Vestri ◽  
Giorgia Borriello ◽  
...  
Keyword(s):  
High Performance ◽  
Foodborne Pathogen ◽  
Surface Enhanced Raman Spectroscopy ◽  
High Performing ◽  
Sensing Platform ◽  
Food Detection ◽  
Raman Enhancement ◽  
Surface Enhanced ◽  
Surface Enhanced Raman ◽  
In Situ Detection

Brucella is a foodborne pathogen globally affecting both the economy and healthcare. Surface Enhanced Raman Spectroscopy (SERS) nano-biosensing can be a promising strategy for its detection. We combined high-performance quasi-crystal patterned nanocavities for Raman enhancement with the use of covalently immobilized Tbilisi bacteriophages as high-performing bio-receptors. We coupled our efficient SERS nano-biosensor to a Raman system to develop an on-field phage-based bio-sensing platform capable of monitoring the target bacteria. The developed biosensor allowed us to identify Brucella abortus in milk by our portable SERS device. Upon bacterial capture from samples (104 cells), a signal related to the pathogen recognition was observed, proving the concrete applicability of our system for on-site and in-food detection.

scholarly journals Decoupling electron and phonon transport in single-nanowire hybrid materials for high-performance thermoelectrics

2021 ◽  
Vol 7 (20) ◽  
pp. eabe6000
Author(s):  
Lin Yang ◽  
Madeleine P. Gordon ◽  
Akanksha K. Menon ◽  
Alexandra Bruefach ◽  
Kyle Haas ◽  
...  
Keyword(s):  
Thermal Conductivity ◽  
Thermal Transport ◽  
Electrical Transport ◽  
High Performance ◽  
Figure Of Merit ◽  
Phonon Transport ◽  
Core Shell ◽  
Nanowire Diameter ◽  
High Performing ◽  
Polycrystalline Thin Films

Organic-inorganic hybrids have recently emerged as a class of high-performing thermoelectric materials that are lightweight and mechanically flexible. However, the fundamental electrical and thermal transport in these materials has remained elusive due to the heterogeneity of bulk, polycrystalline, thin films reported thus far. Here, we systematically investigate a model hybrid comprising a single core/shell nanowire of Te-PEDOT:PSS. We show that as the nanowire diameter is reduced, the electrical conductivity increases and the thermal conductivity decreases, while the Seebeck coefficient remains nearly constant—this collectively results in a figure of merit, ZT, of 0.54 at 400 K. The origin of the decoupling of charge and heat transport lies in the fact that electrical transport occurs through the organic shell, while thermal transport is driven by the inorganic core. This study establishes design principles for high-performing thermoelectrics that leverage the unique interactions occurring at the interfaces of hybrid nanowires.

scholarly journals Dietary and Ergogenic Supplementation to Improve Elite Soccer Players’ Performance

2021 ◽  
pp. 1-7
Author(s):  
Haniel Fernandes
Keyword(s):  
Dietary Supplements ◽  
High Performance ◽  
Scientific Literature ◽  
Soccer Players ◽  
Competitive Sport ◽  
Beetroot Juice ◽  
Improve Performance ◽  
Sustained Release Tablets ◽  
High Level ◽  
Ergogenic Supplements

<b><i>Background:</i></b> Soccer is an extremely competitive sport, where the most match important moments can be defined in detail. Use of ergogenic supplements can be crucial to improve the performance of a high-performance athlete. Therefore, knowing which ergogenic supplements are important for soccer players can be an interesting strategy to maintain high level in this sport until final and decisive moments of the match. In addition, other supplements, such as dietary supplements, have been studied and increasingly referenced in the scientific literature. But, what if ergogenic supplements were combined with dietary supplements? This review brings some recommendations to improve performance of soccer athletes on the field through dietary and/or ergogenic supplements that can be used simultaneously. <b><i>Summary:</i></b> Soccer is a competitive sport, where the match important moments can be defined in detail. Thus, use of ergogenic supplements covered in this review can improve performance of elite soccer players maintaining high level in the match until final moments, such as creatine 3–5 g day<sup>−1</sup>, caffeine 3–6 mg kg<sup>−1</sup> BW around 60 min before the match, sodium bicarbonate 0.1–0.4 g kg<sup>−1</sup> BW starting from 30 to 180 min before the match, β-alanine 3.2 and 6.4 g day<sup>−1</sup> provided in the sustained-release tablets divided into 4 times a day, and nitrate-rich beetroot juice 60 g in 200 mL of water (6 mmol of NO3<sup>−</sup> L) around 120 min before match or training, including a combination possible with taurine 50 mg kg<sup>−1</sup> BW day<sup>−1</sup>, citrulline 1.2–3.4 g day<sup>−1</sup>, and arginine 1.2–6 g day<sup>−1</sup>. <b><i>Key Messages:</i></b> Soccer athletes can combine ergogenic and dietary supplements to improve their performance on the field. The ergogenic and dietary supplements used in a scientifically recommended dose did not demonstrate relevant side effects. The use of various evidence-based supplements can add up to further improvement in the performance of the elite soccer players.

scholarly journals Integrating high-performing electrochemical transducers in lateral flow assay

2021 ◽  
Author(s):  
Antonia Perju ◽  
Nongnoot Wongkaew
Keyword(s):  
High Performance ◽  
Point Of Care ◽  
Low Cost ◽  
High Sensitivity ◽  
Lateral Flow ◽  
Analytical Performance ◽  
Label Free ◽  
High Performing ◽  
Lateral Flow Assays ◽  
Electrochemical Transducers

AbstractLateral flow assays (LFAs) are the best-performing and best-known point-of-care tests worldwide. Over the last decade, they have experienced an increasing interest by researchers towards improving their analytical performance while maintaining their robust assay platform. Commercially, visual and optical detection strategies dominate, but it is especially the research on integrating electrochemical (EC) approaches that may have a chance to significantly improve an LFA’s performance that is needed in order to detect analytes reliably at lower concentrations than currently possible. In fact, EC-LFAs offer advantages in terms of quantitative determination, low-cost, high sensitivity, and even simple, label-free strategies. Here, the various configurations of EC-LFAs published are summarized and critically evaluated. In short, most of them rely on applying conventional transducers, e.g., screen-printed electrode, to ensure reliability of the assay, and additional advances are afforded by the beneficial features of nanomaterials. It is predicted that these will be further implemented in EC-LFAs as high-performance transducers. Considering the low cost of point-of-care devices, it becomes even more important to also identify strategies that efficiently integrate nanomaterials into EC-LFAs in a high-throughput manner while maintaining their favorable analytical performance.

scholarly journals Long Term Interactions of Native and Invasive Species in a Marine Protected Area Suggest Complex Cascading Effects Challenging Conservation Outcomes

Diversity ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 71
Author(s):  
Charalampos Dimitriadis ◽  
Ivoni Fournari-Konstantinidou ◽  
Laurent Sourbès ◽  
Drosos Koutsoubas ◽  
Stelios Katsanevakis
Keyword(s):  
Invasive Species ◽  
Native Species ◽  
High Performance ◽  
Marine Protected Area ◽  
Habitat Degradation ◽  
Population Increase ◽  
Rocky Reef ◽  
Cascading Effects ◽  
High Level

Understanding the interactions among invasive species, native species and marine protected areas (MPAs), and the long-term regime shifts in MPAs is receiving increased attention, since biological invasions can alter the structure and functioning of the protected ecosystems and challenge conservation efforts. Here we found evidence of marked modifications in the rocky reef associated biota in a Mediterranean MPA from 2009 to 2019 through visual census surveys, due to the presence of invasive species altering the structure of the ecosystem and triggering complex cascading effects on the long term. Low levels of the populations of native high-level predators were accompanied by the population increase and high performance of both native and invasive fish herbivores. Subsequently the overgrazing and habitat degradation resulted in cascading effects towards the diminishing of the native and invasive invertebrate grazers and omnivorous benthic species. Our study represents a good showcase of how invasive species can coexist or exclude native biota and at the same time regulate or out-compete other established invaders and native species.

scholarly journals Evaluation of Static Mapping for Dynamic Space-Shared Multi-task Processing on FPGAs

2021 ◽  
Author(s):  
Umar Ibrahim Minhas ◽  
Roger Woods ◽  
Georgios Karakonstantis
Keyword(s):  
High Performance ◽  
Design Space Exploration ◽  
Design Space ◽  
System Throughput ◽  
Design Parameters ◽  
Temporal Constraints ◽  
Shared Resources ◽  
Task Processing ◽  
High Level ◽  
Performance Computing

AbstractWhilst FPGAs have been used in cloud ecosystems, it is still extremely challenging to achieve high compute density when mapping heterogeneous multi-tasks on shared resources at runtime. This work addresses this by treating the FPGA resource as a service and employing multi-task processing at the high level, design space exploration and static off-line partitioning in order to allow more efficient mapping of heterogeneous tasks onto the FPGA. In addition, a new, comprehensive runtime functional simulator is used to evaluate the effect of various spatial and temporal constraints on both the existing and new approaches when varying system design parameters. A comprehensive suite of real high performance computing tasks was implemented on a Nallatech 385 FPGA card and show that our approach can provide on average 2.9 × and 2.3 × higher system throughput for compute and mixed intensity tasks, while 0.2 × lower for memory intensive tasks due to external memory access latency and bandwidth limitations. The work has been extended by introducing a novel scheduling scheme to enhance temporal utilization of resources when using the proposed approach. Additional results for large queues of mixed intensity tasks (compute and memory) show that the proposed partitioning and scheduling approach can provide higher than 3 × system speedup over previous schemes.

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