The certification of the catalytic concentration of alkaline phosphatase in a reconstituted lyophilized material : CRM 371
The report describes the work carried out for certification of the catalytic concentration of alkaline phosphatase [ orthophosphoric monoester phosphohydrolase (alkaline optimum), EC 184.108.40.206 ], (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.
Bibliographic Reference: EUR 11774 EN (1988)
ISBN: ISBN 92-825-9181-6;CD-NA-
Record Number: 198910025 / Last updated on: 1994-12-01
Original language: en
Available languages: en