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In this whitepaper, bioMérieux describe the potential application of BioFire® FilmArray technology – a well-recognised technology used in infectious disease diagnostics – for rapid at-line detection of mycoplasmas in the pharmaceutical industry.
Analytical procedures are necessary to develop products and manufacturing process, to measure critical quality attributes and to ensure the quality of final products.
The accurate determination of trace impurities is of great importance in both pharmaceutical drug development and drug manufacturing. This application note showcases the new photodiode array detector SPD-M40, which measures the concentration of impurities in pharmaceutical products.
As the main excipient for the pharmaceutical industry, water is integral to patient safety and the quality of pharmaceutical products.
Determination of nitrosamines including gentoxic NDMA analysed by GC-MS in Valsartan using direct injection and headspace methods, below required LOD.
A simple, sensitive and selective direct method using IC coupled to a single quadrupole MS to analyse organic acids in drug solutions.
Find out how to manage change under pressure in this white paper by Rachel Carmichael.
Combining advanced hardware and software with a scientific strategy significantly improves the time and quality of method development for impurity identification.
Separate your science from the status quo, advanced solutions offering superior retention time stability, flexible integration and minimal maintenance.
HPLC with HRAM MS method for the determination and quantitation of nitrosamine impurities in drug products consistent with FDA requirements.
Charged aerosol detection is a technique capable of measuring any non-volatile and many semi-volatile species in a pharmaceutical applications.
This application note shows the neutralisation efficiency of ICR swabs for sanitsed surfaces in aseptic manufacturing environments.
This application note shows the detection of low numbers of different bacterial test strains from Neoprene® gloves.
Cleaning validation is an important element to cGMP manufacturing to ensure purity, quality, and potency of drug product.
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
