Collaborative study for the calibration of replacement batches for the European Pharmacopoeia Heparin sodium Biological Reference Preparation.

The European Directorate for the Quality of Medicines and HealthCare (EDQM) organised an international collaborative study under the aegis of the Biological Standardisation Programme, a joint programme of the Council of Europe and the European Commission, to establish replacement batches for the European Pharmacopoeia (Ph. Eur.) Heparin sodium Biological Reference Preparation (BRP). The study involved cali brating candidate BRP batches 5 and 6 in International Units with respect to the World Health Organization (WHO) 6th International Standard for Unfractionated Heparin (07/328) using the anti-IIa and anti-Xa chromo genic assays and the sheep plasma clotting assay as prescribed in the respective Ph. Eur. monographs. Their suitability for use as a titration reference in the assay of protamine sulfate according to the Ph. Eur. mono graph on Protamine sulfate (0569) was also confirmed. They have been adopted by the Ph. Eur. Commission as Ph. Eur. BRP batch 5 and batch 6 respectively, and will be available from the EDQM under catalogue number H0200000 once the predecessor batch has been exhausted.