The certification of the catalytic concentration of creatine kinase BB in a reconstituted lyophilized material : CRM 299Funded under: FP2-BCR 4
This report describes the work carried out for certification of the catalytic concentration of creatine kinase (ATP : creatine N-phosphotransferase, EC 126.96.36.199, CK), in a lyophilised solution of partially purified CK-BB from human placenta 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 less than 0.5% per annum on the basis of accelerated degradation studies. The catalytic concentration of CK in samples of the reconstituted material is certified to be 5.42 +/- 0.17 micro-kat/l or 325 +/- 10 U/l according to the IFCC recommended method at 30 C.
Bibliographic Reference: EUR 13886 EN (1992) 51 pp., FS, ECU 6.25
ISBN: ISBN 92-826-3399-3
Record Number: 199210036 / Last updated on: 1994-12-02
Original language: en
Available languages: en