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Application Notes & Whitepapers 2017

This supplement contains a collection of application notes and whitepapers from some of the leading suppliers to the pharmaceutical industry…

Application Notes & Whitepapers 2017

In this edition:

Representative sampling in process Raman spectroscopy

Kaiser Optical Systems logo

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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Do you know what’s going in? Analysing tablets by NIR spectroscopy

Metrohm logoMetrohm

Drug analysis needs to be cost effective without compromising on accuracy…

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Stearates verification using a handheld Raman analyser

Thermo Fisher Scientific logoThermo 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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Optical pH measurement of contact lens solutions

Ocean Optics logoOcean 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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Improved aseptic processes and monitoring to reduce FDA 483s

Particle Measuring Systems logoParticle 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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Examination of nonsterile products: tests for specified microorganisms

Wickham Laboratories logoWickham Laboratories

For certain product types, there is a requirement for testing to determine the absence of certain microorganisms…

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Raman hyperspectral imaging: an essential tool in the pharmaceutical field

HORIBA Scientific LogoHoriba 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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A new crystallinity gauge: real-time quantification and monitoring of crystallinity in pharmaceuticals

Ondax logoOndax

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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Raman imaging in medical diagnosis and treatment

WITec logoWITec

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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pAVEwayTM – microbial expression system for the efficient large scale production of therapeutic proteins

Fujifilm logoFujifilm 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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Delivering quality results faster: how an Integrated Development Platform can meet the needs of both analytical development and QC teams

IDBS logoIDBS

This whitepaper explains how an Integrated Development Platform can meet the needs of both analytical development and QC…

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Sensitive and flexible bacterial endotoxin testing with the EndoZyme II recombinant Factor C assay using the Synerg HTX microplate reader

Hyglos logoHyglos 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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Cleaning validation – what do you need to consider to ensure a successful outcome?

RSSL LogoRSSL

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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Benefits of web-based solutions applied to eve for bioprocess software

Infors HTInfors 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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Meeting modern data integrity and compliance requirements

Abbott LogoAbbott 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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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

Agilent Technologies logoAgilent 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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Data integrity: technical controls that demonstrate trust

Thermo Fisher Scientific logoThermo 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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The characterisation of polymorphs by thermal analysis

Mettler Toledo LogoMettler 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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Dwell volume and extra-column volume: what are they and how do they impact method transfer

Waters ImageWaters

Method transfer or method scaling across different instrument platforms can be affected by both dwell volume and extra-column dispersion…

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Perform conductivity measurements in compliance with USP <645>

Mettler Toledo LogoMettler 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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Improved efficiency and lower costs using simultaneous testing for TOC and conductivity

Suez_logoSuez

Total Organic Carbon (TOC) and conductivity measurements are required for compendial water quality…

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EPR – the ‘workhorse technique’ that is still enabling scientists to break new ground after 70+ years

Bruker logoBruker Biospin

Electron paramagnetic resonance (EPR) spectroscopy is the only method for the direct detection of species that have unpaired electrons…

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Elemental impurities: certified reference materials for ICH Q3D, USP<232> and <2232> and Ph Eur 5.20

Merck logoMerck

Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources…

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