The Council of Europe’ European Directorate for the Quality of Medicines and Healthcare (EDQM), the organization that guarantees the quality of European drugs, has chosen the Dermatan Sulphate manufactured by BIOIBERICA as their reference standard.
Just as the American USP had done before, the European body which supervises the quality and security of medicines, the EDQM, has issued a paper on Heparin Sodium for the European pharmacopoeia. This new document included the results of a new analysis designed to give the maximum guarantee about the purity and quality of the Heparin.
This analysis first needed to set a methodology, certain working parameters, and some reference standards with which to compare the product (Dermatan sulphate, in this case) as well as any impurities that it may have.
In January 2010, the division of the EDQM in charge of reference standards (Division of Reference Standards and Samples) asked the main manufacturers of Dermatan sulphate to send them samples of pure Dermatan sulphate in order to select the purest and to define it as the reference standard. BIOIBERICA provided a Dermatan sulphate with a purity over 95% that has been approved as the standard of reference. This standard will be supplied to all laboratories which need to make a purity analysis for heparin, so that they can use it as their reference standard.
This decision endorses BIOIBERICA’s leading position on the production and marketing of very high purity Glycosaminoglycans. BIOIBERICA can produce a Dermatan Sulphate with a guaranteed purity of over 95% since they have at their disposal the technology and the know-how necessary to manufacture such a highly specialized product.
