FLUORODOPA F18 Solution for injection Ref.[11031] Active ingredients: Fluorodopa ¹⁸F

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

11.1 Chemical Characteristics

Fluorodopa F18 Injection is a radioactive diagnostic agent used in PET imaging. The active ingredient 6-[18F] Fluoro-L-3, 4-dihydroxyphenylalanine has the molecular formula of C9H10FNO4 with a molecular weight of 214.18, and has the following chemical structure:

Fluorodopa F18 Injection is a sterile, pyrogen-free, clear, colorless solution. Each mL contains between 37 MBq/mL to 1,480 MBq/mL (1 mCi/mL to 40 mCi/mL) of no-carrier added Fluorodopa F18 (6-[18F] Fluoro-L-3, 4-dihydroxyphenylalanine) at the end of synthesis (EOS). There is 40.88 mg Na-EDTA, 140 mg ascorbic acid, and 663 mg ethanol in 28 mL ±1 mL sodium phosphate buffer. The pH of the solution is between 3 and 5.

11.2 Physical Characteristics

Fluorine F18 is a cyclotron produced radionuclide that decays by positron emission to Oxygen O-18 (stable) and has a physical half-life of 109.7 minutes. The principal photons useful for imaging are the dual 511 keV gamma photons, which are produced and emitted simultaneously in opposite direction following positron-electron annihilation (Table 2).

Table 2. Principal Radiation Emission Data for Fluoride F18:

Radiation/Emission % Per Disintegration Mean Energy
Positron(+) 96.73 249.8 keV
Gamma(±)* 193.46 511.0 keV

* Produced by positron annihilation

11.3 External Radiation

The point source air-kerma coefficient for F18 is 3.75 × 10-17 Gy m²/(Bqs). The half-value layer (HVL) for the 511 keV photons is 5 mm lead (Pb). The range of attenuation coefficients for this radionuclide as a function of lead shield thickness is shown in Table 3. For example, the interposition of a 9 mm thickness of Pb, with a coefficient of attenuation of 0.25, will decrease the external radiation by 75%.

Table 3. Radiation Attenuation of 511 keV Photons by lead (Pb) shielding:

Shield thickness (Pb) mm Coefficient of Attenuation
0 0.00
5 0.50
9 0.25
15 0.10
29 0.01
39 0.001
52 0.0001

For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4.

Table 4. Physical Decay Chart for Fluorine F18:

Time Since Calibration Fraction Remaining
0* 1.000
15 min 0.909
30 min 0.826
60 min 0.683
110 min 0.500
220 min 0.250
440 min 0.060
12 hours 0.011
24 hours 0.0001

* Calibration time

Dosage Forms and Strengths

Injection: clear, colorless solution containing 37 MBq/mL to 1,480 MBq/mL (1 mCi/mL to 40 mCi/mL) of Fluorodopa F 18 Injection, at calibration time in a multiple-dose glass vial.

How Supplied

Fluorodopa F18 Injection (NDC 13267-346-57) is supplied as a clear, colorless injection in a septum capped glass vial containing between 37 MBq/mL to 1,480 MBq/mL (1 mCi/mL to 40 mCi/mL), of Fluorodopa F18 at calibration time, in 28 mL ±1 mL.

Manufactured & Distributed by: The Feinstein Institutes for Medical Research, Cyclotron/Radiochemistry Facility, 350 Community Drive, Manhasset, New York 11030

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