Identification and purity test of heparin by NMR - a summary of two years' experience at the Medical Products Agency

Abstract

This paper is a review of published and unpublished results on heparin during the last two years. Results and experiences gathered in our laboratory at MPA in Sweden, from the collaborative NMR study on heparin in Europe (coordinated by EDQM), and from the process of drafting heparin Ph. Eur. monograph texts where new ideas and experiments have been performed. Explanations and guidelines are also presented to clarify the NMR identification test introduced in the sodium and calcium heparin monographs. NMR, strong anion exchange-LC (SAX-LC) and capillary electrophoresis (CE) have been compared in the quantification of over-sulphated chondroitin sulphate (OSCS) and dermatan sulphate (DS) in heparin. In this paper, the term heparin will stand for unfractionated porcine heparin sodium. When other heparin types are mentioned, they will be explicitly named.