Wyatt Technology has announced that its multi-angle light-scattering (MALS) instruments fulfil the latest European Pharmacopoeia (EP) requirements for hydroxyethyl starch characterisation.
The EP 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 characterising HES.
The need for a greater comprehension of pharmaceutical formulations stands behind the EP's directives; therefore, fast and reliable characterisation tools are important in order to efficiently sort out the true properties of the drug substances and excipients such as HES.
The recent report for EP revealed that MALS has been selected as a standard for HES characterisation.
The report requires all pharmaceutical manufacturers to apply this standard in order to market their products in Europe.
Wyatt Technology's Dawn and Minidawn systems are said to overcome the high background noise problems associated with low-angle detectors and allow 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 MALS system is said to 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.
