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Certification-No. 18996.00.00 (D) / 4-000 10 (A)
Solution for intravenous injection in 10-ml injection bottles for
multiple sampling. One injection bottle contains a total activity of
minimum 350 MBq/ml and maximum 2.500 MBq/ml.
Activity (MBq), date of calibration and the volume (ml) are indicated at the packaging.
The spezification data demonstrate: FDG from ZAG Zyklotron AG
is produced with consistently high quality
| pearance of solution: |
clear, uncolored
|
pecific activity:
concentration of activity: |
350 x 109 MBq/g
350 - 2500 MBq/ml |
sterility:
bacterial endotoxines: |
steril
≤ 10 I.E./ml |
osmolality:
pH: |
310 mosmol/kg ± 10 %
6 bis 7.5`` |
radiochemical purity:
18F-FDG
18F-Fluorid
18F-partial hydrolyzate |
≥ 97 %
≤ 2 %
≤ 1 % |
chemical purity:
cryptofix
acetonitrile
acetone
ethanol |
≤ 20 μg/ml
≤ 50 ppm
≤ 100 ppm
≤ 300 ppm |