Thromb Haemost 1975; 34(01): 003-018
DOI: 10.1055/s-0038-1651441
International Committee Business
Schattauer GmbH

Standard for Human Thrombin

I Robertson
1   National Institute for Biological Standards and Control, Hampstead, London NW3 6RB
,
P. J Gaffney
1   National Institute for Biological Standards and Control, Hampstead, London NW3 6RB
,
D. R Bangham
1   National Institute for Biological Standards and Control, Hampstead, London NW3 6RB
› Author Affiliations
Further Information

Publication History

Publication Date:
02 July 2018 (online)

Summary

Ten laboratories took part in an international study of the proposed standard for human thrombin. A freeze-dried preparation (coded 70/157) was shown, using clotting time tests, to be suitable to serve as a standard for the assay of human and bovine thrombin preparations. The study shows that assay variation within laboratories was much less than between laboratories. The preparation was stable, having a negligible estimated loss of potency after ten years under the recommended storage conditions (—20° C in the dark).

Each ampoule of the standard was assigned a potency of 100 units of thrombin activity, and one unit was defined as the activity contained in 0.0853 mg of the freeze-dried preparation.

It was agreed by the participants in the study and by the International Committee on Thrombosis and Haemostasis (Vienna, 1973) that the thrombin preparation coded 70/157 is suitable to serve as an international standard for human thrombin.

 
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