Intertek NMR and CE services for revised European Pharmacopoeia monographs for heparin

Following increased reports of adverse events associated with heparin preparations in the United States of America and some European countries, the European Pharmacopoeia monographs for Heparin Calcium (0332) and Heparin Sodium (0333) have undergone rapid revision and implementation in order to strengthen the level of testing required for quality control. The revised monographs were adopted by the European Pharmacopoeia Commission on 25 June 2008 and are expected to come into effect on 1 August 2008, pending a decision by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH).

These revised documents include new requirements for both NMR spectrometry and capillary electrophoresis analyses which can be supplied by Intertek Pharmaceutical Services from their ASG facility in Manchester, UK. The Intertek ASG laboratory has been carrying out these tests compliant to the specifications of the FDA routinely since the FDA issued their recommendations earlier in 2008. Intertek ASG has been successfully audited by the MHRA for GLP compliance and by the MHRA and the US FDA for cGMP compliance.

Further information:

• Intertek heparin impurity analysis
• EDQM (European Directorate for Quality of Medicines & HealthCare) website. (external link) 
• Intertek ASG NMR and LC-NMR Analysis
• GMP Pharmaceutical Laboratories
• Global Intertek NMR Analytical Capabilities
• FDA Recommendations for Heparin

• Heparin Verunreinigungen Screening