This document discusses quality control and stability testing for omega-3 products. It outlines challenges in testing omega-3 due to its oil-based matrix and susceptibility to oxidation. Common quality control tests for omega-3 include acid value, peroxide value, p-anisidine value, and quantitative assays using GC or LC-MS. Stability studies evaluate products under various temperature and humidity conditions over time. Oxidation is the primary degradation pathway and difficult to quantify due to complex degradation product mixtures. Quality by design principles aim to develop robust analytical methods, evaluate compatibility, and set specifications to ensure product quality and stability.
Novel Approaches to Omega-3 Stability Testing Nutrasource
In the last decade, nutritional oil products such as omega-3s have grown to a multi-billion dollar industry globally. As a result, new analytical testing challenges have arisen from the current trend toward producing more attractive and more appetizing products created for a wider consumer base.
In formulating these "new and improved," better looking and better tasting products, different color and flavor additives are used, which can interfere with the most popular analytical procedure for determining the secondary oxidation of nutritional oil products, the p-anisidine value test.
In order to overcome these analytical challenges, a new alternative method for testing these additive-laden products has been established and is ready for use in this fast growing marketing segment.
Dr. Steven Li provides details about the latest innovation in omega-3 testing and its application in the omega-3 industry, at GOED Exchange 2014.
Development and Validation of Reversed Phase-High-Performance Liquid Chromato...BRNSS Publication Hub
A simple, accurate, precise, and robust in vitro methods developed and validated for measurement of drug release in Aminocaproic Acid tablets. High-performance liquid chromatography (HPLC) method for quantification of drug in dissolution samples of Aminocaproic Acid tablet is developed and validated. 0.1 N Hydrochloric acid is used as dissolution medium and Basket (USP-I) as apparatus at 100 rpm. The sample was withdrawn after 60 min. The developed HPLC method was used for quantitative estimation of drug release in dissolution samples of Aminocaproic Acid tablet. Chromatogram was run through Inertsil ODS 3V, (250 × 4.6 mm), 5 μm. Mobile phase containing buffer solution and methanol in the pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 13.3 g sodium dihydrogen phosphate monohydrate, 500 mg of Heptane-1-sulfonic acid sodium salt, and 1.0 mL of Triethylamine buffer with pH 2.20 adjusted by orthophosphoric acid. Optimized wavelength for Aminocaproic acid was 210 nm. Retention time of Aminocaproic acid was found about 4.0 min; linearity range was 132.605 μg/ml–828.787 μg/ml. The new method was evaluated according to ICH guideline and as far as validation results are concern correlation coefficient value was 0.9999 for the very compound, percentage recovery 100.0%, repeatability results relative standard deviation 0.9 for Aminocaproic acid. The developed HPLC method was found to be a simple and rapid one for regular analysis in professional laboratory.
(originally aired 11-14-12)
Although biofuels are an attractive alternative to fossil fuels, large scale development is currently challenging. Development of renewable fuel characterization, processes, and contaminant analysis using robust analytical methods is needed. Here, focus is on Ion Chromatography—a proven technique for providing fast, reliable answers during research to production—with HPAE-PAD technology for carbohydrate analysis in feedstock and method parameter optimization (including column chemistry) for efficient separation of mono- and disaccharides with good resolution, linearity, and accuracy over a broad dynamic range. Since some residual sucrose and cellobiose may be present, examples of monitoring them and other saccharides is covered, along with their impact on the fermentation process.
In this slide contains Quality control test and Analysis of Wine and Beer.
Presented by: SHAIK GOUSE UL AZAM (Department of pharmaceutical analysis ).
RIPER, anantapur
Q3D - Elemental Impurities: What implications for APIs & excipients suppliers?Quality Assistance s.a.
ICH Q3D Step4 will have to be applied very soon: June 2016 for new Drug Products and
1st January 2018 for all existing DP, making it mandatory for all manufacturers to carry out a risk assessment to control elemental impurities in their DP.
Such evaluation needs to consider all potential sources of Elemental Impurities and obviously, drug product components are probably the most likely contributors.
by Dr Ph. De Raeve, Scientific Director
For more informations : www.quality-assistance.com
Novel Approaches to Omega-3 Stability Testing Nutrasource
In the last decade, nutritional oil products such as omega-3s have grown to a multi-billion dollar industry globally. As a result, new analytical testing challenges have arisen from the current trend toward producing more attractive and more appetizing products created for a wider consumer base.
In formulating these "new and improved," better looking and better tasting products, different color and flavor additives are used, which can interfere with the most popular analytical procedure for determining the secondary oxidation of nutritional oil products, the p-anisidine value test.
In order to overcome these analytical challenges, a new alternative method for testing these additive-laden products has been established and is ready for use in this fast growing marketing segment.
Dr. Steven Li provides details about the latest innovation in omega-3 testing and its application in the omega-3 industry, at GOED Exchange 2014.
Development and Validation of Reversed Phase-High-Performance Liquid Chromato...BRNSS Publication Hub
A simple, accurate, precise, and robust in vitro methods developed and validated for measurement of drug release in Aminocaproic Acid tablets. High-performance liquid chromatography (HPLC) method for quantification of drug in dissolution samples of Aminocaproic Acid tablet is developed and validated. 0.1 N Hydrochloric acid is used as dissolution medium and Basket (USP-I) as apparatus at 100 rpm. The sample was withdrawn after 60 min. The developed HPLC method was used for quantitative estimation of drug release in dissolution samples of Aminocaproic Acid tablet. Chromatogram was run through Inertsil ODS 3V, (250 × 4.6 mm), 5 μm. Mobile phase containing buffer solution and methanol in the pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 13.3 g sodium dihydrogen phosphate monohydrate, 500 mg of Heptane-1-sulfonic acid sodium salt, and 1.0 mL of Triethylamine buffer with pH 2.20 adjusted by orthophosphoric acid. Optimized wavelength for Aminocaproic acid was 210 nm. Retention time of Aminocaproic acid was found about 4.0 min; linearity range was 132.605 μg/ml–828.787 μg/ml. The new method was evaluated according to ICH guideline and as far as validation results are concern correlation coefficient value was 0.9999 for the very compound, percentage recovery 100.0%, repeatability results relative standard deviation 0.9 for Aminocaproic acid. The developed HPLC method was found to be a simple and rapid one for regular analysis in professional laboratory.
(originally aired 11-14-12)
Although biofuels are an attractive alternative to fossil fuels, large scale development is currently challenging. Development of renewable fuel characterization, processes, and contaminant analysis using robust analytical methods is needed. Here, focus is on Ion Chromatography—a proven technique for providing fast, reliable answers during research to production—with HPAE-PAD technology for carbohydrate analysis in feedstock and method parameter optimization (including column chemistry) for efficient separation of mono- and disaccharides with good resolution, linearity, and accuracy over a broad dynamic range. Since some residual sucrose and cellobiose may be present, examples of monitoring them and other saccharides is covered, along with their impact on the fermentation process.
In this slide contains Quality control test and Analysis of Wine and Beer.
Presented by: SHAIK GOUSE UL AZAM (Department of pharmaceutical analysis ).
RIPER, anantapur
Q3D - Elemental Impurities: What implications for APIs & excipients suppliers?Quality Assistance s.a.
ICH Q3D Step4 will have to be applied very soon: June 2016 for new Drug Products and
1st January 2018 for all existing DP, making it mandatory for all manufacturers to carry out a risk assessment to control elemental impurities in their DP.
Such evaluation needs to consider all potential sources of Elemental Impurities and obviously, drug product components are probably the most likely contributors.
by Dr Ph. De Raeve, Scientific Director
For more informations : www.quality-assistance.com
Key Learning Objectives
- Learn how the use of automated software can make SRM development faster and more highly optimized.
- Learn how the use of a compound data store can further simplify method creation.
- Learn how the use of retention time-based SRM acquisition can increase MS/MS sensitivity and make method maintenance easier.
Event Overview:
In recent years, Gas Chromatography-triple quadrupole mass spectrometry has increased in popularity due to its ability to offer lower detection limits in complex matrices, simplified sample prep requirements, and faster analysis times. Of course, new instrument technology presents the need for the acquiring of new skills to harness the advantages offered by its adoption into current workflows.
In this webinar, a strategy for addressing both of these challenges is discussed in the context of new software designed to automate common method development and method maintenance tasks. Also, in addition to making the triple quadrupole easier to use, this strategy can increase sensitivity of the analysis, which will be demonstrated using a complex SRM pesticide method as an example.
For more information: www.thermoscientific.com/tsq8000
Determination of Propionates and Propionic Acid in Bread Samples Using High P...theijes
In the present study, a HPLC method for determination of the preservative propionates in 7 groups of industrial bread samples is described. The separation the propionates were performed on the C18- column and Na2SO4 (8.0 mM) + H2SO4 (1.0 mM): acetonitrile (90:10, v/v %) as mobile phase. The detector wavelength was set at 210 nm. Separation of the propionates was achieved in less than 8 min. The samples first were milled and then extracted with 0.1 mol L-1 NaOH solution under ultrasonic irradiation. After centrifuge, supernatant clear solution was filtered using 0.45 µm Nylon syringe filter and 25 µL of solution was injected to HPLC loop. Analytical characteristics of the method such as limit of detection (LOD= 5 mg L-1 ), recovery percentage (>91%) and reproducibility (RSD=3.5 %) were evaluated. A plot of peak area (y) versus concentration of propionate (x, mg Kg-1 ) was linear over 10-1000 mg Kg-1 . The calibration graph can be described by the equation y = 301.64x + 9963 (r2= 0.991). The levels of propionates in bread samples ranged from 3683-4752 mg Kg-1. The results stated that High performance liquid chromatography is a simple and rapid method for the determination of propionates in bakery products.
Practical Implementation of the New Elemental Impurities Guidelines May 2015SGS
The International Conference on Harmonization (ICH) released its Q3D Guideline for Elemental Impurities in December 2014, initiating reviews and changes in quality testing programs in bio/pharmaceutical companies around the world. In advance of the implementation dates, companies need to assess the risks of potential elemental impurities in their process and materials streams.
In this presentation, experts will review the requirements of elemental impurities guidelines from ICH, the European Pharmacopeia, and United States Pharmacopeia, outline practical recommendations to address implementation challenges, and discuss key considerations for analytical testing programs.
Determination of Sugars, Bioproducts & Degradation Products in Liquid Fractio...BiorefineryEPC™
Determination of Sugars, Bioproducts & Degradation Products in Liquid Fraction Process Samples
YOU AGREE TO INDEMNIFY BiorefineryEPCTM , AND ITS AFFILIATES, OFFICERS, AGENTS, AND EMPLOYEES AGAINST ANY CLAIM OR DEMAND, INCLUDING REASONABLE ATTORNEYS' FEES, RELATED TO YOUR USE, RELIANCE, OR ADOPTION OF THE DATA FOR ANY PURPOSE WHATSOEVER. THE DATA ARE PROVIDED BY BiorefineryEPCTM "AS IS" AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE EXPRESSLY DISCLAIMED. IN NO EVENT SHALL BiorefineryEPCTM BE LIABLE FOR ANY SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES OR ANY DAMAGES WHATSOEVER, INCLUDING BUT NOT LIMITED TO CLAIMS ASSOCIATED WITH THE LOSS OF DATA OR PROFITS, WHICH MAY RESULT FROM ANY ACTION IN CONTRACT, NEGLIGENCE OR OTHER TORTIOUS CLAIM THAT ARISES OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE DATA.
This webinar will provide pesticides residue analysts with valuable information on software method development and data processing for the analysis of pesticide residues in food for both LC–MS and GC–MS. Technical experts will review the latest in software advances to help with data interpretation and reporting.
In this slide contains definition and details of Qualification Of HPLC
Presented by: KHALID KUWAITY (Department of pharmaceutical analysis).RIPER, anantapur
This application note demonstrates the analyses of residual solvents as described in USP<467> carried out with an HS-10 static headspace sampler and a Shimadzu Gas Chromatograph.
Change of Peptides and Free -Amino Acids Contents during Nanjing Dry-Cured Du...Agriculture Journal IJOEAR
— In order to explore the relationship between the change of peptides and free-amino acid (FAA) and its unique flavour, Dry-cured duck samples of different processing phases were used to study the change of free-amino acid by High Performance Liquid Chromatography (HPLC) in this paper, meanwhile the trichloroacetic acid precipitation method for modeling use to establish the quantitative predicated peptides. The changes of small peptides and free amino acids in the process were studied. The results showed that the level and amount of proteolysis increased with the processing time at traditional technology, meanwhile the amount of peptides were positively correlated with FAA contents (R 2 =0.86).
This application note describes the methodology and use of the Shimadzu ICPMS-2030 ICP mass spectrometer for the analysis of trace elements in drinking and fresh waters following the EPA 200.8 method. This method is also used for analysis of wastewater. Here, we demonstrate the stability and sensitivity of the ICPMS-2030 for EPA 200.8 analyses.
The presentation describes the automated process of the system and present a number of applications from sample matrices such as food, polymers, and pharmaceuticals to show the utility of the system.
Stability indicating method development and validation for the simultaneous e...pharmaindexing
Stability indicating method development and validation for the simultaneous estimation of rabeprazole sodium and ketorolac tromethamine in bulk and synthetic mixture by RP-HPLC
This presentation evaluates ASTM D7979-16 for the “direct” analysis of 30 PFCs and compares data to the solid-phase extraction EPA drinking water Method 537.
Improving Downstream Processing: Application of Excipients in DSPMilliporeSigma
Webinar summary:
This webinar will showcase the beneficial potential of using excipients during downstream processing of monoclonal antibodies.
Learning points:
In this webinar, you will see:
* An innovative excipient screening approach simulating low pH stress conditions during protein A chromatography and virus inactivation
* How the application of excipients in buffer systems can significantly improve protein stability and chromatographic performance
Abstract:
Key aspects during downstream purification of biopharmaceutical drugs are purity and process yield. Therefore, the downstream process needs to be designed in a way that the final product which will eventually end up in the patient entails low levels of product- and process related impurities (e.g. high molecular weight aggregates) as well as process related contaminants (e.g. host cell protein levels). In addition to this, the process must be capable of clearing and inactivating viruses to ensure product safety. In this webinar, we will explore the benefits of adding excipients during downstream processing on protein stability, chromatographic performance and viral inactivation.
Key Learning Objectives
- Learn how the use of automated software can make SRM development faster and more highly optimized.
- Learn how the use of a compound data store can further simplify method creation.
- Learn how the use of retention time-based SRM acquisition can increase MS/MS sensitivity and make method maintenance easier.
Event Overview:
In recent years, Gas Chromatography-triple quadrupole mass spectrometry has increased in popularity due to its ability to offer lower detection limits in complex matrices, simplified sample prep requirements, and faster analysis times. Of course, new instrument technology presents the need for the acquiring of new skills to harness the advantages offered by its adoption into current workflows.
In this webinar, a strategy for addressing both of these challenges is discussed in the context of new software designed to automate common method development and method maintenance tasks. Also, in addition to making the triple quadrupole easier to use, this strategy can increase sensitivity of the analysis, which will be demonstrated using a complex SRM pesticide method as an example.
For more information: www.thermoscientific.com/tsq8000
Determination of Propionates and Propionic Acid in Bread Samples Using High P...theijes
In the present study, a HPLC method for determination of the preservative propionates in 7 groups of industrial bread samples is described. The separation the propionates were performed on the C18- column and Na2SO4 (8.0 mM) + H2SO4 (1.0 mM): acetonitrile (90:10, v/v %) as mobile phase. The detector wavelength was set at 210 nm. Separation of the propionates was achieved in less than 8 min. The samples first were milled and then extracted with 0.1 mol L-1 NaOH solution under ultrasonic irradiation. After centrifuge, supernatant clear solution was filtered using 0.45 µm Nylon syringe filter and 25 µL of solution was injected to HPLC loop. Analytical characteristics of the method such as limit of detection (LOD= 5 mg L-1 ), recovery percentage (>91%) and reproducibility (RSD=3.5 %) were evaluated. A plot of peak area (y) versus concentration of propionate (x, mg Kg-1 ) was linear over 10-1000 mg Kg-1 . The calibration graph can be described by the equation y = 301.64x + 9963 (r2= 0.991). The levels of propionates in bread samples ranged from 3683-4752 mg Kg-1. The results stated that High performance liquid chromatography is a simple and rapid method for the determination of propionates in bakery products.
Practical Implementation of the New Elemental Impurities Guidelines May 2015SGS
The International Conference on Harmonization (ICH) released its Q3D Guideline for Elemental Impurities in December 2014, initiating reviews and changes in quality testing programs in bio/pharmaceutical companies around the world. In advance of the implementation dates, companies need to assess the risks of potential elemental impurities in their process and materials streams.
In this presentation, experts will review the requirements of elemental impurities guidelines from ICH, the European Pharmacopeia, and United States Pharmacopeia, outline practical recommendations to address implementation challenges, and discuss key considerations for analytical testing programs.
Determination of Sugars, Bioproducts & Degradation Products in Liquid Fractio...BiorefineryEPC™
Determination of Sugars, Bioproducts & Degradation Products in Liquid Fraction Process Samples
YOU AGREE TO INDEMNIFY BiorefineryEPCTM , AND ITS AFFILIATES, OFFICERS, AGENTS, AND EMPLOYEES AGAINST ANY CLAIM OR DEMAND, INCLUDING REASONABLE ATTORNEYS' FEES, RELATED TO YOUR USE, RELIANCE, OR ADOPTION OF THE DATA FOR ANY PURPOSE WHATSOEVER. THE DATA ARE PROVIDED BY BiorefineryEPCTM "AS IS" AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE EXPRESSLY DISCLAIMED. IN NO EVENT SHALL BiorefineryEPCTM BE LIABLE FOR ANY SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES OR ANY DAMAGES WHATSOEVER, INCLUDING BUT NOT LIMITED TO CLAIMS ASSOCIATED WITH THE LOSS OF DATA OR PROFITS, WHICH MAY RESULT FROM ANY ACTION IN CONTRACT, NEGLIGENCE OR OTHER TORTIOUS CLAIM THAT ARISES OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE DATA.
This webinar will provide pesticides residue analysts with valuable information on software method development and data processing for the analysis of pesticide residues in food for both LC–MS and GC–MS. Technical experts will review the latest in software advances to help with data interpretation and reporting.
In this slide contains definition and details of Qualification Of HPLC
Presented by: KHALID KUWAITY (Department of pharmaceutical analysis).RIPER, anantapur
This application note demonstrates the analyses of residual solvents as described in USP<467> carried out with an HS-10 static headspace sampler and a Shimadzu Gas Chromatograph.
Change of Peptides and Free -Amino Acids Contents during Nanjing Dry-Cured Du...Agriculture Journal IJOEAR
— In order to explore the relationship between the change of peptides and free-amino acid (FAA) and its unique flavour, Dry-cured duck samples of different processing phases were used to study the change of free-amino acid by High Performance Liquid Chromatography (HPLC) in this paper, meanwhile the trichloroacetic acid precipitation method for modeling use to establish the quantitative predicated peptides. The changes of small peptides and free amino acids in the process were studied. The results showed that the level and amount of proteolysis increased with the processing time at traditional technology, meanwhile the amount of peptides were positively correlated with FAA contents (R 2 =0.86).
This application note describes the methodology and use of the Shimadzu ICPMS-2030 ICP mass spectrometer for the analysis of trace elements in drinking and fresh waters following the EPA 200.8 method. This method is also used for analysis of wastewater. Here, we demonstrate the stability and sensitivity of the ICPMS-2030 for EPA 200.8 analyses.
The presentation describes the automated process of the system and present a number of applications from sample matrices such as food, polymers, and pharmaceuticals to show the utility of the system.
Stability indicating method development and validation for the simultaneous e...pharmaindexing
Stability indicating method development and validation for the simultaneous estimation of rabeprazole sodium and ketorolac tromethamine in bulk and synthetic mixture by RP-HPLC
This presentation evaluates ASTM D7979-16 for the “direct” analysis of 30 PFCs and compares data to the solid-phase extraction EPA drinking water Method 537.
Improving Downstream Processing: Application of Excipients in DSPMilliporeSigma
Webinar summary:
This webinar will showcase the beneficial potential of using excipients during downstream processing of monoclonal antibodies.
Learning points:
In this webinar, you will see:
* An innovative excipient screening approach simulating low pH stress conditions during protein A chromatography and virus inactivation
* How the application of excipients in buffer systems can significantly improve protein stability and chromatographic performance
Abstract:
Key aspects during downstream purification of biopharmaceutical drugs are purity and process yield. Therefore, the downstream process needs to be designed in a way that the final product which will eventually end up in the patient entails low levels of product- and process related impurities (e.g. high molecular weight aggregates) as well as process related contaminants (e.g. host cell protein levels). In addition to this, the process must be capable of clearing and inactivating viruses to ensure product safety. In this webinar, we will explore the benefits of adding excipients during downstream processing on protein stability, chromatographic performance and viral inactivation.
Many software organizations struggle with documenting information as well as deciding what information should be recorded and maintained. The most obvious information that needs to be documented are the product and project requirements, but that is not all. This presentation discusses what happens to the organization when it does not document information in the areas of Engineering, Project Management, Support, and Process Management. At the end is a simple and easy way of addressing this problem once you have decided what information you must record.
Agricultural Commodity Analysis and Trade Issues for ShippingMathew Conoulty
David Conoulty of Commodity Inspection Services outlines the various factors involved with testing for the quality of agricultural commodities during the shipping process. The presentation covers the analysis process, the reliability of results, analytical methods and the improved equipment used to perform quality laboratory analysis.
The determination of the oxidation stability of oils and fats is the classical application for the 743 Rancimat. The resulting induction time that is determined characterizes the resistance of oils and fats to oxidation. In addition to the term «induction time», the expression Oil Stability Index (OSI) is in common use. The Rancimat method is also called the automated Swift test or accelerated oxidation test and is in general use today as an automated version of the previously used and extremely complicated Active Oxygen Method (AOM).
This was a presidentation presented at the Cutting through the haze of vaping: A Town Hall discussion on Vaping during the AOAC INTERNATIONAL Midyear Meeting, March 9-13, 2020. Full audio is available https://www.aoac.org/news/audiocast-an-expert-discussion-on-vaping/
CHROMacademy Premier Membership offers chemical analysts the opportunity to learn at their own pace or use our tutor supported training courses. Webcasts, Live-on-the-Web and Live @ Your Place offer live training in group settings
Founded by Dr. Robert S. McQuate and Dr. Richard C. Kraska, two seasoned regulatory veterans with over 60 years’ collective experience working for and with the FDA, GRAS Associates provides customized food safety and compliance regulatory consulting solutions for products regulated by the U.S. Food and Drug Administration (FDA), including products which may be considered to be Generally Recognized as Safe (GRAS).
Diteba is a global leader in complex analytical and bioanalytical testing, providing solutions and services to the pharmaceutical, biopharmaceutical and nutraceutical industries.
We support both large and small molecule testing for various dosage forms including solids, semi-solids, liquids, aerosols and other special dosage forms. Our work is focused in several core areas including: In Vitro Release Rate Testing (IVRT) services; stability storage and testing; method development and validation and QC testing at our fully accredited facility.
In this presentation, you'll learn more about Nutrasource, a contract research organization and consulting from that provides a vertically integrated, virtual R&D consulting service platform for the entire consumer health products industry.
The Value of Product-Specific Data for Marketing and Sales ROINutrasource
As regulatory requirements for foods and health products tighten across the world and product categories become increasingly competitive, more companies than ever are investing in research and development (R&D) to help their products stay novel, comply with regulations and stand out in the marketplace. Product-specific data is the common and trending theme that meets these objectives. In order to generate this data successfully and within budget, companies must ensure they are maximizing their return on investment (ROI) as it relates to product sales and marketing. This lecture will provide you with valuable information about the value of product-specific data for marketing and sales, and discuss specific strategies your company can use to maximize your return on this investment.
The International Fish Oil Standards (IFOS) Program: An OverviewNutrasource
The International Fish Oil Standards (IFOS) Program is the only third party testing and certification program for the fish oil industry. We help companies add market value to their brands so that they stand out on the shelf as symbols of purity, safety and stability. www.ifosprogram.com
A Global Perspective on Food Health Claims Nutrasource
On Wednesday, August 21st, Pulse Canada hosted an expert panel workshop in Toronto on the potential for a health claim related to Lentils and Post-prandial Glycaemia in Toronto. Invited delegates to the workshop included over 30 representatives from the pulse industry, food industry, academia as well as and regulatory experts. The purpose of the workshop was to provide a forum in which to discuss a systematic literature review that was conducted in 2012 by Nutrasource Diagnostics Inc (NDI) with respect to achieving a health claim related to lentils and short term blood sugar control in Canada, the US or the EU.
Krista Coventry from NDI presented a background on the regulatory frameworks in Canada, the US, the EU and Australia/New Zealand.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
Observation of Io’s Resurfacing via Plume Deposition Using Ground-based Adapt...Sérgio Sacani
Since volcanic activity was first discovered on Io from Voyager images in 1979, changes
on Io’s surface have been monitored from both spacecraft and ground-based telescopes.
Here, we present the highest spatial resolution images of Io ever obtained from a groundbased telescope. These images, acquired by the SHARK-VIS instrument on the Large
Binocular Telescope, show evidence of a major resurfacing event on Io’s trailing hemisphere. When compared to the most recent spacecraft images, the SHARK-VIS images
show that a plume deposit from a powerful eruption at Pillan Patera has covered part
of the long-lived Pele plume deposit. Although this type of resurfacing event may be common on Io, few have been detected due to the rarity of spacecraft visits and the previously low spatial resolution available from Earth-based telescopes. The SHARK-VIS instrument ushers in a new era of high resolution imaging of Io’s surface using adaptive
optics at visible wavelengths.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
Slide 1: Title Slide
Extrachromosomal Inheritance
Slide 2: Introduction to Extrachromosomal Inheritance
Definition: Extrachromosomal inheritance refers to the transmission of genetic material that is not found within the nucleus.
Key Components: Involves genes located in mitochondria, chloroplasts, and plasmids.
Slide 3: Mitochondrial Inheritance
Mitochondria: Organelles responsible for energy production.
Mitochondrial DNA (mtDNA): Circular DNA molecule found in mitochondria.
Inheritance Pattern: Maternally inherited, meaning it is passed from mothers to all their offspring.
Diseases: Examples include Leber’s hereditary optic neuropathy (LHON) and mitochondrial myopathy.
Slide 4: Chloroplast Inheritance
Chloroplasts: Organelles responsible for photosynthesis in plants.
Chloroplast DNA (cpDNA): Circular DNA molecule found in chloroplasts.
Inheritance Pattern: Often maternally inherited in most plants, but can vary in some species.
Examples: Variegation in plants, where leaf color patterns are determined by chloroplast DNA.
Slide 5: Plasmid Inheritance
Plasmids: Small, circular DNA molecules found in bacteria and some eukaryotes.
Features: Can carry antibiotic resistance genes and can be transferred between cells through processes like conjugation.
Significance: Important in biotechnology for gene cloning and genetic engineering.
Slide 6: Mechanisms of Extrachromosomal Inheritance
Non-Mendelian Patterns: Do not follow Mendel’s laws of inheritance.
Cytoplasmic Segregation: During cell division, organelles like mitochondria and chloroplasts are randomly distributed to daughter cells.
Heteroplasmy: Presence of more than one type of organellar genome within a cell, leading to variation in expression.
Slide 7: Examples of Extrachromosomal Inheritance
Four O’clock Plant (Mirabilis jalapa): Shows variegated leaves due to different cpDNA in leaf cells.
Petite Mutants in Yeast: Result from mutations in mitochondrial DNA affecting respiration.
Slide 8: Importance of Extrachromosomal Inheritance
Evolution: Provides insight into the evolution of eukaryotic cells.
Medicine: Understanding mitochondrial inheritance helps in diagnosing and treating mitochondrial diseases.
Agriculture: Chloroplast inheritance can be used in plant breeding and genetic modification.
Slide 9: Recent Research and Advances
Gene Editing: Techniques like CRISPR-Cas9 are being used to edit mitochondrial and chloroplast DNA.
Therapies: Development of mitochondrial replacement therapy (MRT) for preventing mitochondrial diseases.
Slide 10: Conclusion
Summary: Extrachromosomal inheritance involves the transmission of genetic material outside the nucleus and plays a crucial role in genetics, medicine, and biotechnology.
Future Directions: Continued research and technological advancements hold promise for new treatments and applications.
Slide 11: Questions and Discussion
Invite Audience: Open the floor for any questions or further discussion on the topic.
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
Richard's entangled aventures in wonderlandRichard Gill
Since the loophole-free Bell experiments of 2020 and the Nobel prizes in physics of 2022, critics of Bell's work have retreated to the fortress of super-determinism. Now, super-determinism is a derogatory word - it just means "determinism". Palmer, Hance and Hossenfelder argue that quantum mechanics and determinism are not incompatible, using a sophisticated mathematical construction based on a subtle thinning of allowed states and measurements in quantum mechanics, such that what is left appears to make Bell's argument fail, without altering the empirical predictions of quantum mechanics. I think however that it is a smoke screen, and the slogan "lost in math" comes to my mind. I will discuss some other recent disproofs of Bell's theorem using the language of causality based on causal graphs. Causal thinking is also central to law and justice. I will mention surprising connections to my work on serial killer nurse cases, in particular the Dutch case of Lucia de Berk and the current UK case of Lucy Letby.
Cancer cell metabolism: special Reference to Lactate PathwayAADYARAJPANDEY1
Normal Cell Metabolism:
Cellular respiration describes the series of steps that cells use to break down sugar and other chemicals to get the energy we need to function.
Energy is stored in the bonds of glucose and when glucose is broken down, much of that energy is released.
Cell utilize energy in the form of ATP.
The first step of respiration is called glycolysis. In a series of steps, glycolysis breaks glucose into two smaller molecules - a chemical called pyruvate. A small amount of ATP is formed during this process.
Most healthy cells continue the breakdown in a second process, called the Kreb's cycle. The Kreb's cycle allows cells to “burn” the pyruvates made in glycolysis to get more ATP.
The last step in the breakdown of glucose is called oxidative phosphorylation (Ox-Phos).
It takes place in specialized cell structures called mitochondria. This process produces a large amount of ATP. Importantly, cells need oxygen to complete oxidative phosphorylation.
If a cell completes only glycolysis, only 2 molecules of ATP are made per glucose. However, if the cell completes the entire respiration process (glycolysis - Kreb's - oxidative phosphorylation), about 36 molecules of ATP are created, giving it much more energy to use.
IN CANCER CELL:
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
introduction to WARBERG PHENOMENA:
WARBURG EFFECT Usually, cancer cells are highly glycolytic (glucose addiction) and take up more glucose than do normal cells from outside.
Otto Heinrich Warburg (; 8 October 1883 – 1 August 1970) In 1931 was awarded the Nobel Prize in Physiology for his "discovery of the nature and mode of action of the respiratory enzyme.
WARNBURG EFFECT : cancer cells under aerobic (well-oxygenated) conditions to metabolize glucose to lactate (aerobic glycolysis) is known as the Warburg effect. Warburg made the observation that tumor slices consume glucose and secrete lactate at a higher rate than normal tissues.
Comparing Evolved Extractive Text Summary Scores of Bidirectional Encoder Rep...University of Maribor
Slides from:
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Track: Artificial Intelligence
https://www.etran.rs/2024/en/home-english/
11. The common active ingredients added in
omega-3
1. Minerals
• Calcium
• Selenium
• Chromiun
• Zinc
2. Vitamins
• Vitamin D
• Vitamin A
• Coenzyme Q10
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3. Antioxidants
• Vitamin E (alpha and
gamma tocopherols)
• Vitamin C and
derivatives (Ascobyl
palmatate)
4. Others (Antibiotics,
Hormones or Biologics)
13. New product development
• Applications (Enteral, Parenteral and Topical)
• Taste and Appearance
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• Bioavailability
•Multiple health benefits
• Stability
15. Now let’s see if we really do quality
control for the products
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16. 3 QbD things useful for omega-3-like
products
1. Can a product be easily tested?
a) Is there a reliable method or compendial method
for testing a product?
b) Has a method been verified for a product?
2. Is the formulation compatible?
3. Is a product stable in storage?
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17. Challenges of quality control methods for
testing omega-3 products
• Oil Based Matrix---- Solubility and
Homogeneity
• Continuous Oxidation Process----Stability
• Complexity of Formulation----Interfering
Additives or
Ingredients for testing
• Less Specific----Less Supportive.
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18. Test methods for omega-3 fatty acids
• Fatty Acid Oxidation
• Release Testing of API and Products
• Microbiological Tests
• Heavy Metal Tests
• Pesticides Tests
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19. Oxidation is the main degradation
pathway of omega-3
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Oxidation Heat & Light
Degradation
28. Unique features of omega-3 containing
products and stability testing
• Most of them are softgel capsules, oil liquid or oil
based suspension
• Most common degradation is oxidation and the
degradation impurities are mixtures of multiple
compounds.
• It is extremely difficult to have a stability indicating
method for Omega-3 fatty acids since the degradation
products are variable and difficult to be easily identified
and quantified using simply analytical methods.
• Most of current methods for testing oxidation products
are not specific and directly quantitative for the
degradation products.
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29. Challenges in quality control and stability
study of omega-3 products
• Oil Based Matrix-Homogeneity
• Unstable Due to Continuous Oxidation Process
• Need More Efficient and Specific QC Analytical
Methods
• Formulated Product with Interfering Additives
or Ingredients for the Current Test Methods
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30. General storage conditions in stability
studies
• Storage ICH
Walk-in and Reach-in Chambers
• Storage Conditions
25°C/60% RH
30°C/65% RH
40°C/75% RH
Photostability
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31. Specifications in stability study
• Stability studies should include testing of those attributes of
the API that are susceptible to change during storage and
are likely to influence quality, safety and/or efficacy.
• The testing should cover, as appropriate, the physical,
chemical, biological and microbiological attributes. A guide
as to the potential attributes to be tested in the stability
studies.
• Validated stability-indicating analytical procedures should
be applied.
• Whether and to what extent replication should be
performed will depend on the results from validation
studies
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32. Stability and testing frequency
• For APIs with a proposed re-test period or shelf-life of at
least 12 months, the frequency of testing at the long-term
storage condition should normally be every three months
over the first year, every six months over the second year,
and annually thereafter throughout the proposed re-test
period or shelf-life.
• At the accelerated storage condition , a minimum of three
time points, including 0, 3, and 6 month.
• When testing at the intermediate storage condition a
minimum of four time points, including the initial and final
time points (e.g. 0, 6, 9 and 12 months), from a 12-month
study is recommended.
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37. Fancy term but common logic
Quality by Design (QbD)
1. Analytical Methods
2. Compatibility Study (3 Month)
3. Specifications
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38. QbD principles
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Desired
State of
Product
ICH Q8-
Pharm.Dev
elopment
ICH Q10
Quality
System
ICH Q9-Quality
Risk
Management
39. Fate of drug product and philosophy
• Only Very Small % Drug Products Get FDA Approval
Product
Philosophy
Fate of
Product
Application
Confirmation
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Formula
Quality
Control
Tox
Product
Philosophy
Fate of
Product
Formula
QbD
Quality
Control
Application
Confirmation
Tox
40. Thank you!
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Dr. Steve Li, MD, M.Sc. (Clin. Pharm)
Director of Laboratory Operations
stevel@diteba.com
Connect with Diteba
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