European Pharmacopeia Adopts Revised Heparin Monographs

Strasbourg, France (June 25)-The European Pharmacopoeia Commission  (EPC) adopted revised monographs for heparin calcium and heparin sodium to strengthen the level of testing required for quality control. The revised monographs are scheduled to become effective on Aug. 1, 2008, pending a decision by the European Committee on Pharmaceuticals and Pharmaceutical Care.

Before the EPC meeting, a workshop on the characterization and quality control of heparins was held in Strasbourg on June 19–20. The workshop was jointly organized by the European Directorate for the Quality of Medicines and Healthcare, the National Institute for Biological Standards and Control, and the United States Pharmacopeia.

At the meeting, officials from Europe, Japan, and the US discussed nuclear magnetic resonance, capillary electrophoresis, and other analytical methods that might be appropriate for controlling heparin quality. The workshop primarily focused on unfractionated heparin, but one session was dedicated to low molecular weight heparins (LMWHs) and the possible need to update the monographs in the respective pharmacopoeias.

During the workshop, officials from the three Pharmacopeias identified globalization as a challenge for ensuring the quality of heparin. Participants recognized the need for setting a common standard and developing a harmonized approach to define a potency assay based on a common international unit.

All three Pharmacopoeias are committed to establishing harmonized monographs for heparin and LMWH that include state-of-the-art quality control.

See also “USP Posts Revised Heparin Monographs” from the June 26 edition of ePT.