Whitepaper: Improved efficiency and lower costs using simultaneous testing for TOC and conductivity
Total Organic Carbon (TOC) and conductivity measurements are required for compendial water quality...
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Whitepapers & App Notes
Whitepaper: The ‘workhorse technique’ that is still enabling scientists to break new ground after 70+ years
Electron paramagnetic resonance (EPR) spectroscopy is the only method for the direct detection of species that have unpaired electrons...
Whitepaper: Perform conductivity measurements in compliance with USP <645>
“Water is the most widely used substance, raw material, or ingredient in the production, processing and formulation of compendial articles...”
Application Note: Elemental Impurities
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources...
Whitepaper: Cleaning validation – what do you need to consider to ensure a successful outcome?
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..
Whitepaper: Sensitive and flexible bacterial endotoxin testing with the EndoZyme® II Recombinant Factor C Assay using the Synergy™ HTX Microplate Reader
This article covers how the EndoZyme II assay is established, optimised and validated using the SynergyTM HTX Multi-Mode Microplate Reader with Gen5TM software...
Whitepaper: How an integrated development platform can meet the needs of both analytical development and QC teams
This whitepaper explains how an Integrated Development Platform can meet the needs of both analytical development and QC...
Application Note: Stearates verification using a handheld Raman analyzer
In this application, a Principal Component Analysis (PCA) method was found to be successful in identifying the various stearates...
Application note: Representative sampling in process Raman spectroscopy
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..
Whitepaper: Meeting modern data integrity and compliance requirements
FDA was perhaps understating a point when it said in its April 2016 Draft Guidance: Data Integrity and Compliance with cGMP that the increasing number of data integrity-related cGMP violations identified during its inspections was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’...
Whitepaper: Dwell Volume and Extra-Column Volume: What are they and how do they impact method transfer
Method transfer or method scaling across different instrument platforms can be affected by both dwell volume and extra-column dispersion...
Whitepaper: Improved aseptic processes and monitoring to reduce FDA 483s
In recent years, the FDA response to companies with insufficient proof of control over their production has become more aggressive...
Application Note: The characterisation of polymorphs by thermal analysis
TGA-FTIR was used to characterize and distinguish between different polymorphs...
Whitepaper: Extractables and leachables testing – A risk based approach
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient...
Whitepaper: Data Integrity: Technical controls that demonstrate trust
Using Chromeleon 7 Chromatography Data System for enhanced data integrity...
