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DOI: 10.1055/s-0037-1614165
A Collaborative Study to Establish the 5th International Standard for Unfractionated Heparin
We would like to thank the participants of the study and the following manufacturers for their kind donation of candidate samples: Diosynth bv, 5340 BH Oss, The Netherlands; Crinos Industria Farmacobiologica SpA, 22079 Villa Guardia, Como, Italy; Laboratori Derivati Organici, SS 31 bis Trino, Italy; Leo Pharmaceutical Products Ltd, 55 Industriparken, DK-2750 Ballerup, Denmark; Pharmacia & Upjohn, 160 Industrial Drive, Franklin, Ohio 45005, USA; Scientific Protein Laboratories, 700 E Main Street, Waunakee, USA; New Zealand Pharmaceuticals Ltd, Palmerston North 5330, Linton, New Zealand.Publication History
Received
19 March 2000
Accepted after resubmission
10 July 2000
Publication Date:
13 December 2017 (online)
Summary
Twenty-four laboratories participated in a collaborative study to calibrate a replacement for the 4th International Standard for Unfractionated Heparin (82/502). Both candidate materials A and B, gave excellent intra- and inter-laboratory variations (majority of mean %gcv <10%) when assayed against the 4th International Standard. No major differences of potency estimates were found between methods, although the USP method generally gave lower potencies than the other methods and candidate B gave a greater variation between methods than A. Overall, this study showed that the differences between the candidates are marginal. Based on its narrower molecular weight profile, higher specific activity and slightly lower inter-method variation, candidate A, 97/578, was proposed and accepted in October, 1998, by the Expert Committee on Biological Standardisation of the World Health Organisation to be the 5th International Standard for Unfractionated Heparin with an assigned potency of 2031 IU/ampoule.
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