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Rapid Revision of Heparin monographs June 2008

04 July 2008

On June 26th 2008, the European Pharmacopoeia Commission, in accordance with the provisions of Article 6, paragraph c of the Convention on the Elaboration of the European Pharmacopoeia, adopted the revised version of the monographs Heparin sodium (333) and Heparin calcium (332), the texts of which are set out in the attachment to this announcement. Furthermore the Commission has decided to set 1st August 2008 as the date on which the states parties to the Convention shall implement, within their territories, the revised version of these monographs Heparin sodium (333) and Heparin calcium (332). Consequently the Irish Medicines Board would like to inform all users of the European Pharmacopoeia that these revised texts will become official in Ireland on that date, 1st August 2008.

The revisions to the monograph affect primarily the production sections of the monographs which have been amended to deal with recent concerns regarding contamination of heparin, in particular with the presence of the impurity over-sulphated chondroitin sulphate (OSCS) which has been linked with serious hypotensive and allergic reactions in patients.

The changes made relate to the source animals and the revised text makes clear that it is not acceptable to mix different animal tissues in manufacturing a single batch of heparin. There is introduced a requirement that the material must be manufactured in such a way as to ensure freedom from contamination by over-sulphated glycosaminoglycans, including OSCS. In addition each batch also must comply with the screening requirements for such potential contaminants using proton NMR spectroscopy (minimum frequency 300MHz) and capillary electrophoresis, in accordance with specifications approved by IMB in the marketing authorisations for individual products, or for use in the manufacture of products, intended to be marketed in Ireland.

It should also be noted that such requirements apply  by extension to low molecular mass heparins, since by definition these are manufactured from heparin of natural origin that complies with the requirements of the monographs for Heparin sodium (0333) or Heparin calcium(0332), as appropriate.  

Date Printed: 18 April 2014

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