Application Notes & Whitepapers 2017
Posted: 16 January 2018 | European Pharmaceutical Review | No comments yet
This supplement contains a collection of application notes and whitepapers from some of the leading suppliers to the pharmaceutical industry…
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In this edition:
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[zl_tabs_cell title=”Representative sampling in process Raman spectroscopy” right_icon=”fa-angle-down”]
Kaiser Optical Systems
Raman spectroscopy is an analysis technique that provides a “molecular fingerprint” of the sample, enabling analysis of chemical composition and molecular structure without sample preparation…
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[zl_tabs_cell title=”Do you know what’s going in? Analysing tablets by NIR spectroscopy” right_icon=”fa-angle-down”]
Metrohm
Drug analysis needs to be cost effective without compromising on accuracy…
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[zl_tabs_cell title=”Stearates verification using a handheld Raman analyser” right_icon=”fa-angle-down”]
Thermo Fisher Scientific
In this application, a Principal Component Analysis (PCA) method was found to be successful in identifying the various stearates…
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[zl_tabs_cell title=”Optical pH measurement of contact lens solutions” right_icon=”fa-angle-down”]
Ocean Optics
Various sources estimate that more than 125 million people worldwide wear contact lenses – their popularity having grown appreciably as lenses have become safer and more effective…
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[zl_tabs_cell title=”Improved aseptic processes and monitoring to reduce FDA 483s” right_icon=”fa-angle-down”]
Particle Measuring Systems
In recent years, the FDA response to companies with insufficient proof of control over their production has become more aggressive…
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[zl_tabs_cell title=”Examination of nonsterile products: tests for specified microorganisms” right_icon=”fa-angle-down”]
Wickham Laboratories
For certain product types, there is a requirement for testing to determine the absence of certain microorganisms…
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[zl_tabs_cell title=”Raman hyperspectral imaging: an essential tool in the pharmaceutical field” right_icon=”fa-angle-down”]
Horiba Scientific
Resulting from the combination of Raman spectroscopy and optical microscopy, Raman hyperspectral imaging has proven to be an indispensable tool in the pharmaceutical field. This article will broach a number of Raman hyperspectral imaging applications that were developed in our laboratory, to demonstrate the significance of the technique…
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[zl_tabs_cell title=”A new crystallinity gauge: real-time quantification and monitoring of crystallinity in pharmaceuticals” right_icon=”fa-angle-down”]
Ondax
The measurement and quantification of crystallinity in pharmaceuticals is of vital importance, as this has a direct influence on the solubility and stability of the final drug product, affecting both efficacy and expiration…
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[zl_tabs_cell title=”Raman imaging in medical diagnosis and treatment” right_icon=”fa-angle-down”]
WITec
Confocal Raman imaging is a non-destructive microscopy technique that can identify the molecules in a sample and visualise their distribution in three dimensions…
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[zl_tabs_cell title=”pAVEwayTM – microbial expression system for the efficient large scale production of therapeutic proteins” right_icon=”fa-angle-down”]
Fujifilm Diosynth Biotechnologies
pAVEway™ is an innovative expression system in E. coli that enables rapid creation of novel recombinant strains and the development of downstream processes that ensure industry leading product titres and efficient scale-up of the production of proteins of therapeutic utility…
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[zl_tabs_cell title=”Delivering quality results faster: how an Integrated Development Platform can meet the needs of both analytical development and QC teams” right_icon=”fa-angle-down”]
IDBS
This whitepaper explains how an Integrated Development Platform can meet the needs of both analytical development and QC…
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[zl_tabs_cell title=”Sensitive and flexible bacterial endotoxin testing with the EndoZyme II recombinant Factor C assay using the Synerg HTX microplate reader” right_icon=”fa-angle-down”]
Hyglos bioMérieux
This article covers how the EndoZyme II assay is established, optimised and validated using the SynergyTM HTX Multi-Mode Microplate Reader with Gen5TM software…
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[zl_tabs_cell title=”Cleaning validation – what do you need to consider to ensure a successful outcome?” right_icon=”fa-angle-down”]
RSSL
This white paper discusses the over-arching strategy for performing a successful cleaning validation, with detail on some of the key factors to consider at both the manufacturing, microbiological and analytical stages, highlighting many common pitfalls to avoid..
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[zl_tabs_cell title=”Benefits of web-based solutions applied to eve for bioprocess software” right_icon=”fa-angle-down”]
Infors HT
The development of powerful, modern browsers and the proliferation of mobile platforms has altered the way in which programs run and where data is stored…
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[zl_tabs_cell title=”Meeting modern data integrity and compliance requirements” right_icon=”fa-angle-down”]
Abbott Informatics
FDA was perhaps understating a point when it said in its April 2016 Draft Guidance: Data Integrity and Compliance with cGMP that the increasing number of data integrity-related cGMP violations identified during its inspections was ‘troubling’…
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[zl_tabs_cell title=”Analysis of extractable and leachable metals in plastic materials of construction as per USP <661.1> acid extraction procedure using the Agilent 5110 VDV ICP-OES” right_icon=”fa-angle-down”]
Agilent Technologies
Plastic packaging systems for pharmaceutical use include, but are not limited to bags, bottles, vials, ampoules, cartridges, dry powder and metered dose inhalers, syringes, blisters, pouches and their associated closures and secondary components like labels and printing overpouches…
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[zl_tabs_cell title=”Data integrity: technical controls that demonstrate trust” right_icon=”fa-angle-down”]
Thermo Fisher Scientific
An increased focus on data integrity by international regulatory agencies has led to serious consequences for several companies. It has also resulted in data integrity becoming one of the top reported global issues that regulated companies face…
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[zl_tabs_cell title=”The characterisation of polymorphs by thermal analysis” right_icon=”fa-angle-down”]
Mettler Toledo
If two polymorphic forms of a solid are present, whereby one form melts and the other sublimes or vaporizes at about the same temperature, then evolved gas analysis can be used to obtain quantitative (mass loss) and qualitative (spectral) data to analyse such solids.
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[zl_tabs_cell title=”Dwell volume and extra-column volume: what are they and how do they impact method transfer” right_icon=”fa-angle-down”]
Waters
Method transfer or method scaling across different instrument platforms can be affected by both dwell volume and extra-column dispersion…
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[zl_tabs_cell title=”Perform conductivity measurements in compliance with USP <645>” right_icon=”fa-angle-down”]
Mettler Toledo
“Water is the most widely used substance, raw material, or ingredient in the production, processing and formulation of compendial articles…”
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[zl_tabs_cell title=”Improved efficiency and lower costs using simultaneous testing for TOC and conductivity” right_icon=”fa-angle-down”]
Suez
Total Organic Carbon (TOC) and conductivity measurements are required for compendial water quality…
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[zl_tabs_cell title=”EPR – the ‘workhorse technique’ that is still enabling scientists to break new ground after 70+ years” right_icon=”fa-angle-down”]
Bruker Biospin
Electron paramagnetic resonance (EPR) spectroscopy is the only method for the direct detection of species that have unpaired electrons…
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[zl_tabs_cell title=”Elemental impurities: certified reference materials for ICH Q3D, USP<232> and <2232> and Ph Eur 5.20″ right_icon=”fa-angle-down”]
Merck
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources…
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Issue
Related topics
Analytical techniques, Data Analysis, QA/QC, Raman Spectroscopy
Related organisations
Abbott Informatics, Agilent Technologies, Bruker Biospin, Fujifilm Diosynth Biotechnologies, HORIBA Scientific, Hyglos-bioMerieux, IDBS, Infors HT, Kaiser Optical Systems, Merck, Metrohm, METTLER TOLEDO, Ocean Optics, Ondax, Particle Measuring Systems, Reading Scientific Services Limited, SUEZ, Thermo Fisher Scientific, Waters, Wickham Laboratories, WITec
