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A collaborative study to establish an international standard for alpha-thrombin.

P J Gaffney¹, A B Heath, J W Fenton

¹National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK.

Thrombosis and Haemostasis

|April 2, 1992

Summary

A new international standard for pure alpha-thrombin was established to improve the accuracy of thrombin measurements and inhibitor quantification. This stable, lyophilized preparation (89/588) was assigned a potency of 100 IU per ampoule.

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Area of Science:

Biochemistry
Haematology
Standardization

Background:

An International Standard for thrombin of low purity has been in use since 1975.
A need for a pure alpha-thrombin standard emerged for accurate calibration and precise measurement of thrombin inhibitors like hirudin.

Purpose of the Study:

To establish the potency and stability of a new ampouled pure alpha-thrombin preparation.
To provide a reliable standard for alpha-thrombin measurement and inhibitor quantification.

Main Methods:

An international collaborative study was conducted.
A clotting-assay procedure was used to determine potency.
Stability was assessed at various elevated temperatures.

Main Results:

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A potency of 97.5 international units (95% confidence limits 86.5-98.5) was established for the alpha-thrombin standard (89/588).
Stability data confirmed no significant loss of potency during transport and storage.
The preparation was recommended as an International Standard with an assigned potency of 100 IU per ampoule.

Conclusions:

The lyophilized pure alpha-thrombin preparation (89/588) is suitable as an International Standard.
This new standard will enhance the accuracy of thrombin calibration and the measurement of thrombin inhibitors.