Analytical procedures for quality control of pharmaceuticals in terms of residual solvents content: Challenges and recent developments

2016 ◽  
Vol 80 ◽  
pp. 328-344 ◽  
Author(s):  
Maciej Tankiewicz ◽  
Jacek Namieśnik ◽  
Wiesław Sawicki
Keyword(s):  
Quality Control ◽  
Residual Solvents ◽  
Recent Developments ◽  
Analytical Procedures

scholarly journals Isoflavone Stability Quality Control Assessment of Q-CAN® Plus, a Novel Fermented Soy Beverage (P12-034-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Wajahat Mehal ◽  
Eric Secor ◽  
Theresa Weiss ◽  
Maxine Fields ◽  
Michael Leapman ◽  
...  
Keyword(s):  
Heavy Metals ◽  
Quality Control ◽  
Microbial Contamination ◽  
Soy Isoflavones ◽  
Third Party ◽  
Biological Research ◽  
Residual Solvents ◽  
Funding Sources ◽  
Relevant Dose ◽  
Mold And Yeast

Abstract Objectives The purpose of this investigation is to validate the soy isoflavone content, 24 months stability and quality control of “Q-CAN® Plus,” a novel fermented soy beverage imported from China. Methods Q-CAN® Plus was independently tested through third-party laboratories for: Soy isoflavones, microbial contamination, herbicides, pesticides, fungicides, heavy metals and residual solvents. To evaluate the potency or stability, total soy isoflavones were measured over 24 months through accelerated (40 degrees Celsius 75% relative humidity) and shelf (ambient temperature) and microbial contamination evaluated. Results Upon initial analysis Q-CAN® Plus contained 290.12 mg of total soy isoflavones. Microbial contamination, mold and yeast were absent or WNLs. Product was free of herbicides, pesticides, fungicides, heavy metals and residual solvents. The mean total isoflavones was 303.23 mg +/− 11.5 mg (SD). The 24-month stability testing in both the accelerated chamber (12 mo = 294 mg, 24 mo = 318 mg) and shelf (12 mo = 304 mg, 24 mo = 310 mg) determined that total soy isoflavones did not significantly change in potency, and microbiology analysis at each time point revealed no contamination. Conclusions In this first independent evaluation of Q-CAN® Plus it was determined that the manufacturer's Certificate of Analysis was validated, soy isoflavones remained stable over 24 months, and microbial contamination was absent. Q-CAN® Plus is a functional beverage that provides a high quality, clinically relevant dose of soy isoflavones. Future investigations will determine the clinical benefit of this natural fermented soy beverage. Funding Sources Beso Biological Research, Inc.

scholarly journals “Opinion and Fact, Perspective and Truth”: Seeking Truthfulness and Integrity in Coaching and Coach Education

2020 ◽  
pp. 1-7
Author(s):  
John Stoszkowski ◽  
Áine MacNamara ◽  
Dave Collins ◽  
Aran Hodgkinson
Keyword(s):  
Social Media ◽  
Quality Control ◽  
Internet Access ◽  
Poor Quality ◽  
Sources Of Information ◽  
Coach Education ◽  
Analytical Thinking ◽  
Recent Developments ◽  
Positive Step

Recent developments have seen a growth in coaching, with an associated boom in interest on how it may be optimised. Clearly, the authors applaud this evolution. This growth has been parallelled by an explosion in the availability of information, driven through Internet access and the phenomenon of social media. Unfortunately, however, this juxtaposition of interest and availability has not been matched by the application or exercise of effective quality control. While much of what is available is well intentioned, a tendency for poor quality and possibly less positively targeted “bullshit” has also arisen. In this insights paper, the authors have considered some of the reasons why and argued that an emphasis on the development of critical and analytical thinking, as well as a scepticism towards the sources of information, would be a positive step against coach susceptibility to bullshit. In doing so, and to encourage more critical consumption of the “knowledge” available, the authors presented a checklist to help coaches assess the veracity of claims and sift through the noise of the coaching landscape.

Analytical variation in metabolic profile testing

1973 ◽  
Vol 40 (1) ◽  
pp. 85-92 ◽  
Author(s):  
R. Manston ◽  
G. J. Rowlands
Keyword(s):  
Quality Control ◽  
Metabolic Profile ◽  
Dairy Herds ◽  
Population Variance ◽  
Analytical Variance ◽  
Average Population ◽  
Analytical Procedures ◽  
Analytical Variation

SummaryResults are presented demonstrating quality control of the analytical procedures used during the application of metabolic profile tests to dairy herds over a period of 3 years. The significance of analytical variance is discussed in relation to the average population variance in dairy herds.It is concluded that analytical variance can be restricted to reasonable proportions providing that careful quality control is continuously employed.

Recent developments in the determination of residual solvents in pharmaceutical products by microextraction methods

2015 ◽  
Vol 7 (20) ◽  
pp. 8511-8523 ◽  
Author(s):  
Majid Mirmoghaddam ◽  
Massoud Kaykhaii ◽  
Hossein Yahyavi
Keyword(s):  
Pharmaceutical Products ◽  
Residual Solvents ◽  
Recent Developments

Recent developments in the determination of residual solvents in pharmaceutical products by microextraction methods.

scholarly journals Analytical procedure for quality control of 18F-Choline radiopharmaceutical

2021 ◽  
Vol 63 (5) ◽  
pp. 10-16
Author(s):  
Thanh Quang Vu ◽  
◽  
Ngoc Khoan Ha ◽  
Thanh Rin Bui ◽  
Trung Dung Nguyen ◽  
...  
Keyword(s):  
Quality Control ◽  
High Performance ◽  
Radiochemical Purity ◽  
Analytical Procedure ◽  
Hplc Method ◽  
Central Hospital ◽  
Residual Solvents ◽  
Quality Specifications ◽  
Pet Radiopharmaceutical ◽  
Required Quality

18Fluoromethylcholine (18F-Choline, 18F-FCH) has been produced using a home-made automatic synthesiser at 30 MeV Cyclotron Centre, 108 Military Central Hospital. In order to be licensed using for patients, the 18F-FCH radiopharmaceutical needs to meet the required quality specifications listed in the pharmacopeia. The objective of this study was to build up the analytical procedure and to perform for the 18F-FCH quality control followed the EuPh2017 pharmacopeia for the PET radiopharmaceutical. The result obtained confirmed that the total time to complete the test of one sample of the 18F-FCH was less than 35 min. Identifications of 18F-FCH, radiochemical purity, and 18F content were determined with accuracy >96% by High-performance liquid chromatography (HPLC) method and content of residual solvents consists of Ethanol, Acetonitrile, Dibromomethane, Dimethylethanolamine were determined with the accuracy >97% by Gas chromatography (GC) method.

scholarly journals Recent Development and Future Perspectives of Quality Control and Assurance for the Deep Mixing Method

2021 ◽  
Vol 11 (19) ◽  
pp. 9155
Author(s):  
Masaki Kitazume
Keyword(s):  
Quality Control ◽  
Soil Stabilization ◽  
Mechanical Mixing ◽  
Deep Mixing ◽  
Recent Developments ◽  
Stabilized Soil ◽  
Mixing Method ◽  
Stabilization Technique

The deep mixing method (DMM), an in situ soil stabilization technique, was developed in Japan and Nordic countries in the 1970s and has gained increased popularity in many countries. The quality of stabilized soil depends upon many factors, including its type and condition, the type and amount of binder, and the production process. Quality control and quality assurance (QC/QA) practices focus on stabilized soil, and comprises laboratory mix tests, field trial tests, monitoring and controlling construction parameters, and verification. QC/QA is one of the major concerns for clients and engineers who have less experience with the relevant technologies. In this manuscript, the importance of QC/QA-related activities along the workflow of deep mixing projects is emphasized based on the Japanese experience/results with mechanical mixing technology by vertical shaft mixing tools with horizontal rotating circular mixing blade. The current and recent developments of QC/QA are also presented.

Developments in mycotoxin analysis: an update for 2019-2020

2021 ◽  
Vol 14 (1) ◽  
pp. 3-26 ◽  
Author(s):  
S.A. Tittlemier ◽  
J. Brunkhorst ◽  
B. Cramer ◽  
M.C. DeRosa ◽  
V.M.T. Lattanzio ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Quality Control ◽  
Quality Assurance ◽  
High Resolution Mass Spectrometry ◽  
Tandem Mass ◽  
Mass Spectrometry Detection ◽  
Recent Developments ◽  
Mycotoxin Analysis ◽  
Instrumental Methods ◽  
Resolution Mass

This review summarises developments on the analysis of various matrices for mycotoxins published in the period from mid-2019 to mid-2020. Notable developments in all aspects of mycotoxin analysis, from sampling and quality assurance/quality control of analytical results, to the various detection and quantitation technologies ranging from single mycotoxin biosensors to comprehensive instrumental methods are presented and discussed. Aside from sampling and quality control, discussion of this past year’s developments is organised by detection and quantitation technology and covers chromatography with targeted or non-targeted high resolution mass spectrometry, tandem mass spectrometry, detection other than mass spectrometry, biosensors, as well as assays that use alternatives to antibodies. This critical review aims to briefly present the most important recent developments and trends in mycotoxin determination as well as to address limitations of the presented methodologies.

Benefits, limitations, and controversies on patient-based real-time quality control (PBRTQC) and the evidence behind the practice

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Huub H. van Rossum ◽  
Andreas Bietenbeck ◽  
Mark A. Cervinski ◽  
Alex Katayev ◽  
Tze Ping Loh ◽  
...  
Keyword(s):  
Quality Control ◽  
Real Time ◽  
Cost Efficiency ◽  
Moving Average ◽  
Daily Practice ◽  
Added Value ◽  
Current Status ◽  
Average Quality ◽  
Medical Laboratories ◽  
Recent Developments

Abstract Background In recent years, there has been renewed interest in the “old” average of normals concept, now generally referred to as moving average quality control (MA QC) or patient-based real-time quality control (PBRTQC). However, there are some controversies regarding PBRTQC which this review aims to address while also indicating the current status of PBRTQC. Content This review gives the background of certain newly described optimization and validation methods. It also indicates how QC plans incorporating PBRTQC can be designed for greater effectiveness and/or (cost) efficiency. Furthermore, it discusses controversies regarding the complexity of obtaining PBRTQC settings, the replacement of iQC, and software functionality requirements. Finally, it presents evidence of the added value and practicability of PBRTQC. Outlook Recent developments in, and availability of, simulation methods to optimize and validate laboratory-specific PBRTQC procedures have enabled medical laboratories to implement PBRTQC in their daily practice. Furthermore, these methods have made it possible to demonstrate the practicability and added value of PBRTQC by means of two prospective “clinical” studies and other investigations. Although internal QC will remain an essential part of any QC plan, applying PBRTQC can now significantly improve its performance and (cost) efficiency.

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