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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...
Using Chromeleon 7 Chromatography Data System for enhanced data integrity...
The work presented here investigates the development and application of new bioprocess analytics in accordance with the aims of QbD...
This selective detection method greatly improves the prospect of detecting nitrosamines in pharmaceutical products and medical devices that incorporate rubber or latex...
In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation...
In this application note, PerkinElmer describes how the Spectrum Two N™ FT-NIR spectrometer can be deployed using a workflow approach, suitable for a regulated environment, to overcome a range of different challenges in raw material identification...
The SWILE technology is the first fully automated true one-to-one gravimetric "pick & decision dispense" of compounds...
In this whitepaper, Metrohm discuss the standardisation organisations put forward for analytical instruments requirements with a focus on software...
With confocal Raman imaging the molecules of a sample can be chemically identified and their distribution can be imaged three-dimensionally...
Production of protein therapeutics by mammalian cells is the most widely used bioprocess because of its ability to properly produce and fold a recombinant protein...
This application note describes a sensitive, fast and accurate LC/MS/MS quantitation method utilising a QSight™ 110 Triple Quadrupole Mass Spectrometer for the simultaneous analysis of the immunosuppressant drugs tacrolimus, sirolimus and cyclosporine A in serum, using everolimus as an internal standard...
With confocal Raman imaging the molecules of a sample can be chemically identified and their distribution can be imaged three-dimensionally...
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics. These challenges mostly arise from the size and complexity of the virus...
Raman spectroscopy has been successfully integrated in laboratory, pilot, process development and GMP manufacturing environments. Find out how it was used at the pilot scale to detect the endpoint of a heterogeneous etherification reaction...
In this application note, HORIBA discuss using raman spectroscopy to study the distribution of compounds in pharmaceutical drug products...
