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The Medicine Maker / Issues / 2016 / Articles / Jun / Using GPC/SEC for excipient characterization
Manufacture Business Practice Clinical Trials Drug Delivery Ingredients Formulation Small Molecules Technology and Equipment Bioprocessing - Single Use Systems Dosage Forms Trends & Forecasts Development & Clinical Drug Delivery Formulation Small Molecules Facilities & Equipment Technology & Manufacturing Bioprocessing Biopharma

Using GPC/SEC for excipient characterization

06/16/2016 1 min read

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Polymeric excipients are a critical component of sophisticated tableting blends with closely controlled drug release profiles. In this article, Stephen Ball, Product Marketing Manager Nanometrics, Malvern Instruments, demonstrates how state-of-the-art gel permeation/size exclusion chromatography (GPC/SEC) systems can be used to measure the Critical Quality Attributes of such excipients with exemplary sensitivity.

The resulting data enables formulators to efficiently and securely identify excipients with the molecular weight (MW), MW distribution and structural characteristics to deliver safe and efficacious performance.  >> Download the full article for FREE  

Malvern Instruments provides the materials and biophysical characterization technology and expertise that enable scientists and engineers to understand and control the properties of dispersed systems. These systems range from proteins and polymers in solution, particle and nanoparticle suspensions and emulsions, through to sprays and aerosols, industrial bulk powders and high concentration slurries. Used at all stages of research, development and manufacturing, Malvern’s materials characterization instruments provide critical information that helps accelerate research and product development, enhance and maintain product quality and optimize process efficiency. Our products reflect Malvern’s drive to exploit the latest technological innovations and our commitment to maximizing the potential of established techniques. They are used by both industry and academia, in sectors ranging from pharmaceuticals and biopharmaceuticals to bulk chemicals, cement, plastics and polymers, energy and the environment. Malvern systems are used to measure particle size, particle shape, zeta potential, protein charge, molecular weight, mass, size and conformation, rheological properties and for chemical identification, advancing the understanding of dispersed systems across many different industries and applications. Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, Mexico, China, Japan and Korea, a joint venture in India, a global distributor network and applications laboratories around the world. www.malvern.com severine.michel@malvern.com

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