Table 5:
Results from Production Validation Campaign
| Release Criterial | Specification | Qual Runs 1A & 1B | Qual Runs 2A & 2B | Qual Runs 3A & 3B |
|---|---|---|---|---|
| Appearance | Clear, Colorless, No Particulates | Clear, colorless, no particulates | Clear, colorless, no particulates | Clear, colorless, no particulates |
| Radiochemical Identity (% difference from Ref Std) by HPLC | NMT 10% | 1.64 % 2.09 % |
2.85 % 2.74 % |
2.87 % 2.62 % |
| Radiochemical Purity (%) (HPLC) | ≥ 90% | 99.75 % 99.68 % |
98.63 % 98.44 % |
98.71% 98.70 % |
| Total Chemical Impurities | NMT 50 μg/dose | 0.1205 μg/mL 0.0628 μg/mL |
0.0343 μg/mL 0.0523 μg/mL |
0.0882 μg/mL 0.0236 μg/mL |
| Molar Activity | ≥ 18.5 GBq/μmol | 555 GBq/μmol 627 GBq/μmol |
816 GBq/μmol 970 GBq/μmol |
985 GBq/μmol 996 GBq/μmol |
| Bacterial Endotoxin Levels (EU/mL) | NMT 8.75 EU/mL | < 1.00 EU/mL < 1.00 EU/mL |
< 1.00 EU/mL < 1.00 EU/mL |
< 1.00 EU/mL < 1.00 EU/mL |
| Radionuclidic Identity (t1/2, minutes) | 19.38 – 21.42 | 20.35 min 20.35 min |
20.27 min 20.40 min |
20.251 min 20.347 min |
| Residual Ethanol Level, ppm (NMT 78,900) | NMT 78900 ppm (10% EtOH) | 59811 ppm 36359 ppm |
60437 ppm 51539 ppm |
58969 ppm 52953 ppm |
| Residual 2-Butanone Level, ppm (NMT 5000) | ≤ 5000 ppm | 7.083 ppm 14.916 ppm |
9.358 ppm 15.009 ppm |
7.099 ppm 23.610 ppm |
| pH | 4 – 8 | 4.0 4.0 |
4.0 4.0 |
4.0 4.0 |
| Filter Integrity | > 40 psi | Pass Pass |
Pass Pass |
Pass Pass |
| Sterility (Observed growth after 14 d) | No Growth | No Growth No Growth |
No Growth No Growth |
No Growth No Growth |
| Amount of Product | Report | 3922 MBq 3485 MBq |
2579 MBq 4240 MBq |
3807 MBq 3249 MBq |