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Table 2 Product release specifications and validation test results of [18F]MC225

From: Automated synthesis, preclinical toxicity, and radiation dosimetry of [18F]MC225 for clinical use: a tracer for measuring P-glycoprotein function at the blood-brain barrier

QC test Release criteria* Run 1 Run 2 Run 3
Visual inspection Clear, colorless to slightly yellow solution, free of particulate matter Pass Pass Pass
Radiochemical identity Retention time of [18F]MC225 peak within ± 10% min compared with the retention time of the known reference MC225 peak 7.1% 4.4% 4.3%
Radionuclide identity by 511 keV peak Peak energy of gamma ray spectrum at 511 keV Pass Pass Pass
Radionuclide identity by half-life determination 105–115 min 110 min 108 min 115 min
Content of ethanol ≤ 10% (v/v) 7.3% 6.7% 6.6%
Residual acetonitrile ≤ 410 μg/mL 36.8 μg/mL 75.4 μg/mL 121.7 μg/mL
Residual dimethylformamide ≤ 880 μg/mL N.D. N.D. N.D.
Residual o-dichlorobenzene ≤ 25 μg/mL 9.35 μg/mL 5.41 μg/mL 3.86 μg/mL
Content of MC225 ≤ 10μg/dose 0.5 μg/dose 0.6 μg/dose 0.9 μg/dose
Total content of MC225 and related impurities ≤ 10μg/dose 5.4 μg/dose 6.2 μg/dose 3.3 μg/dose
pH 6.0 to 8.5 6.2 6.2 6.3
Radiochemical purity at release ≥ 90% 98.7% 99.2% 99.6%
Molar activity at end of synthesis N/A 1613 GBq/μmol 2002 GBq/μmol 1112 GBq/μmol
Residual K.222 ≤ 40 μg/mL Pass Pass Pass
Bacterial endotoxins < 150 EU/vial < 48.5 EU < 53.3 EU < 51.3 EU
Sterility testing No growth observed in 14 days Pass Pass Pass
Filter integrity by bubble point testing ≥ 40 psi 48 psi 44 psi 44 psi
  1. *Release criteria apply to a maximum administration volume of 10 mL