POSLUMA is a sterile, non-pyrogenic, clear, colorless, and isotonic solution. Each mL contains up to 20 mcg of flotufolastat gallium, up to 5,846 MBq (158 mCi) as flotufolastat F 18 gallium at end of synthesis, and the following inactive ingredients: not more than 10 % ( v/v) alcohol, 1.9 mg anhydrous citric acid, 7.2 mg sodium chloride, and 0.75 mg sodium hydroxide to adjust pH between 4 and 6. POSLUMA contains no preservative. 11.2 Physical Characteristics POSLUMA contains fluorine-18 (F 18) which is a cyclotron produced radionuclide that decays by positron emission (β+ decay, 96.7%) and orbital electron capture (3.3%) to stable oxygen -18 with a physical half-life of 109.8 minutes (Table 3). The principal photons useful for diagnostic imaging are the coincident pair of 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 4). Table 3: Physical Decay Chart for Fluorine-18 Minutes Fraction Remaining 0 1 15 0.909 30 0.826 60 0.683 110 0.5 220 0.25
Table 4:
Principal Radiation Produced from Decay of Fluorine-18 Energy (keV)
Abundance (%)
Positron Gamma
249.8
96.7 193.5
511
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Reference ID: 5180081
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