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18F-FDG-FZK
Product Specification

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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.

appearance of solution:	clear, uncolored
specific 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