ABSTRACT
Due to the diminished stocks of the 2nd batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for human albumin for electrophoresis, the European Directorate for the Quality of Medicines & HealthCare (EDQM) initiated in 2014 an international collaborative study for the establishment of two replacement batches. The study was run under the aegis of the Biological Standardisation Programme (BSP). Thirteen laboratories participated in the collaborative study to verify the suitability of the candidate reference preparations according to the Ph. Eur. monograph 0255 using the zone electrophoresis (ZE) method with either cellulose acetate and/or agarose as the testing medium. The candidate preparations were found suitable for the intended purpose and were subsequently adopted in June 2015 by the Ph. Eur. Commission as human albumin for electrophoresis BRP batches 3 and 4 with an assigned range for albumin of 93.8 per cent to 98.3 per cent of the total protein content.
