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Thromb Haemost 1979; 41(03): 576-582
DOI: 10.1055/s-0038-1646810
Original Articles
Schattauer GmbH Stuttgart

A in Vivo Assay for Standardizing Heparin Preparations

A R Pomeroy
The National Biological Standards Laboratory, Department of Health Canberra, A. C. T., Australia
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Further Information

Publication History

Received 21 April 1978

Accepted 08 June 1978

Publication Date:
09 July 2018 (online)

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Summary

The limitations of currently used in vitro assays of heparin have demonstrated the need for an in vivo method suitable for routine use.

The in vivo method which is described in this paper uses, for each heparin preparation, four groups of five mice which are injected intravenously with heparin according to a “2 and 2 dose assay” procedure. The method is relatively rapid, requiring 3 to 4 hours to test five heparin preparations against a standard preparation of heparin. Levels of accuracy and precision acceptable for the requirements of the British Pharmacopoeia are obtained by combining the results of 3 to 4 assays of a heparin preparation.

The similarity of results obtained the in vivo method and the in vitro method of the British Pharmacopoeia for heparin preparations of lung and mucosal origin validates this in vivo method and, conversely, demonstrates that the in vitro method of the British Pharmacopoeia gives a reliable estimation of the in vivo activity of heparin.

 

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