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The report describes the work carried out for certification of the catalytic concentration of alkaline phosphatase [ orthophosphoric monoester phosphohydrolase (alkaline optimum), EC ], (AP), in a lyophilized solution of partially purified AP from pig kidney dissolved in a bovine serum albumin matrix. The preparation has been shown to be homogeneous, and the loss of activity on storage at -20 C is predicted to be 0.01% per annum on the basis of accelerated degradation studies. The catalytic concentration of AP in samples of the reconstituted material is certified to be (4.23±0.01)microkat/l or (254±6)U/l according to the IFCC recommended method at 30 C. Reconstitution must be carried out at 0 C and, once reconstituted, the sample must be kept in an ice-water bath prior to the assay, in order to avoid time and temperature dependent increase of activity of the AP preparation.

Additional information

Authors: SCHIELE F, Centre du Medicament, Université de Nancy (FR)
Bibliographic Reference: EUR 11774 EN (1988)
Availability: (2)
ISBN: ISBN 92-825-9181-6;CD-NA-
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