Table 3 Production and QC results of the pilot batches
\( {1}^{\underline{0}} \) | \( {2}^{\underline{0}} \) | \( {3}^{\underline{0}} \) | \( {4}^{\underline{0}} \) | \( {5}^{\underline{0}} \) | \( {6}^{\underline{0}} \) | \( {7}^{\underline{0}} \) | |
|---|---|---|---|---|---|---|---|
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 |