Wyatt Technology MALS Fulfils Latest European Pharmacopoeia Standard for HES Characterization
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Wyatt Technology Corporation, has announced that its Multi-Angle Light Scattering (MALS) instruments represent the latest European Pharmacopoeia (EP) requirements for hydroxyethyl starch (HES) characterization.
The European Pharmacopoeia is a single reference work developed by the European Directorate for the Quality of Medicines (EDQM).
The official standards published within it provide a legal and scientific basis for quality control for all producers of medicines and/or substances for pharmaceutical use.
A new publication within the EP specifically indicates that MALS instrumentation is the standard for characterizing HES.
The need for a greater comprehension of pharmaceutical formulations stands behind the EP’s directives. Therefore, fast and reliable characterization tools are of great importance in order to efficiently sort out the true properties of the drug substances and excipients such as HES.
The recent report from European Pharmacopoeia revealed that MALS has been selected as a standard for HES characterization. The report requires all pharmaceutical manufacturers to apply this standard in order to market their products in the Europe.
Wyatt’s DAWN and miniDAWN systems have long been recognized as the “Gold standard” for MALS technology. Indeed, for the past two and a half decades, they have been the de facto MALS systems in the world.
They overcome the high background noise problems associated with low angle detectors and allow a reliable and accurate measurements of the light scattered at a plurality of angles, simultaneously.
The amount of light scattered is then directly related to the molar mass. Wyatt’s novel, patented MALS systems offer researchers the ability to determine absolute molar masses and sizes of all types of macromolecules and particles in solution.
MALS also enables the elucidation of additional data such as branching, confirmation, and sample behaviour and allows the observation of molecular interactions in a real-time environment.