Handbook: Pharmaceuticals: collected applications
In this handbook, collected applications for pharmaceuticals are examined...
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Whitepapers & App Notes
Application Note: Real-time quality prediction of continuously produced pharmaceutical granules
Continuous manufacturing approaches have been gaining interest in the pharmaceutical industry. They allow shorter production times, enable novel reaction pathways, increase assurances of product quality and help to realise cost savings...
Handbook: Evolved gas analysis: collected applications
Mass spectrometry is an extremely sensitive method for the detection and identification of traces of gaseous substances. The technique can quantify atoms or molecules and provide chemical and structural information (functional groups and side chains) on the compounds analysed...
Application Note: Raman-based endpoint detection of a heterogeneous etherification reaction
Regulatory guidelines, from the 2004 U.S. FDA PAT framework to ICH Q8, Q9, Q10 and Q11 documents, have brought a shift to pharmaceutical processes and manufacturing...
Handbook: Validation in thermal analysis: collected applications
It is important to realise early in your project that if you are validating a computerised system, you do not just concentrate on the computer hardware and software. Validation encompasses more, as will be discussed within this handbook...
Application Note: Raman-based nutrient control in bioprocessing optimizes viable cell density and protein glycation
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...
Handbook: Thermal analysis in practice: collected applications
For quantitative results, the curves obtained from the measurement instrument have to be properly evaluated. Often, several different procedures are available for calculating numerical results from the curves...
Application Note: Raman monitoring of active coating composition
Pharmaceutical tablets are coated for a variety of reasons, such as to enhance the appearance, taste, chemical stability, or swallowability of the tablet or to create a particular release profile for the active pharmaceutical ingredient (API)...
Application Note: Particle characterisation of pharmaceutical powder mixtures (count, size and chemistry)
For the study of a pharmaceutical drug product, particle characteristics (count, size and chemistry) and compound distributions (size and spatial) are among key parameters that strongly determine the quality of the product...
Application Note: Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing
Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing...
Application Note: Examination of non-sterile products: tests for specified microorganisms
For certain product types, there is a requirement for testing to determine the absence of certain microorganisms...
Application Note: Analysis of extractable and leachable metals in plastic materials of construction as per USP <661.1>
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...
Application Note: A new crystallinity gauge: Real-time quantification and monitoring of crystallinity in pharmaceuticals
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...
Application Note: Raman imaging in medical diagnosis and treatment
Confocal Raman imaging is a non-destructive microscopy technique that can identify the molecules in a sample and visualise their distribution in three dimensions...
Application Note: Benefits of web-based solutions applied to eve for bioprocess software
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...
