Skip to main content

Table 3 Production and QC results of the pilot batches

From: Synthesis of an Al18F radiofluorinated GLU-UREA-LYS(AHX)-HBED-CC PSMA ligand in an automated synthesis platform

  \( {1}^{\underline{0}} \) \( {2}^{\underline{0}} \) \( {3}^{\underline{0}} \) \( {4}^{\underline{0}} \) \( {5}^{\underline{0}} \) \( {6}^{\underline{0}} \) \( {7}^{\underline{0}} \)
Production parameters
 Activity produce by cylotron(MBq) 17,700 34,400 57,500 50,600 50,600 59,200 80,000
 Final Activity(MBq) 2,660 5,760 7,800 10,270 9,580 13,140 17,350
 Final volume(mL) 5.80 6.16 6.09 5.13 4.20 5.71 5.75
 Yield(EOS)(%) 15.0 16.8 13.6 20.3 18.9 22.2 21.7
QC parameters
 pH 7.0 7.0 7.0 7.0 7,0 7.0 7.0
 Radiochemical purity(%) 92.8 100 96.8 94.0 95.1 96.2 91.7
 Residual solvent OK OK OK OK OK OK OK
 Ethanol(%) 6.0 5.6 5.9 5.0 5.2 4.1 4.8
 t1/2(min) 107 108 110 115 109 109 107
 Pyrogen (EU/mL) < 10 < 10 < 13.3 < 10 < 10 < 10 < 10
 Sterility sterile sterile sterile sterile sterile sterile sterile
 Specific activity (GBq/umol) 58 180 210 357 329 412 544