Manufacturer’s specifications for
68Ga-DOTA-NOC,
solution for injection
ACTIVE INGREDIENT:
OTHER EXCIPIENTS:
[Galllium-68-Dota, 1-NaI3]-octreotide
Sodium acetate, hydrochloride acid, sodium chloride, ethanol,
water for injection
Specifications
APPEARANCE:
RADIOCHEMICAL PURITY:
RADIONUCLIDIC PURITY:
pH:
STERILITY:
BACTERIAL ENDOTOXINS:
EXPIRATION:
Clear and colorless solution
≥ 2 MBq/μg eli 2,9 MBq/nmol
(Eur J Nucl Med Mol Imaging 2010; 37:2004-2010)
≥ 91,0 %
≥ 99,0 %
5,0 – 8,5
Sterile
< 175 IU/dose
3 hours after calibration time
VOLUME:
≤ 15 ml (multidose vial)
STORAGE:
Room temperature (20 – 25 °C)
GALLIUM 18:
Half-Life
68 minutes
Gamma energy
511 KeV
SPECIFIC RADIOACTIVITY:
ETHANOL:
≤ 10% V/V
MANUFACTURER:
MAP MEDICAL TECHNOLOGIES OY
Saukonpaadenranta 2
00180 Helsinki
Kivihaantie 7F
00310 Helsinki
MANUFACTURING AUTHORISATION
NUMBER:
3483/11.01.02/2011