Table 2.
Comparison of % RCY data obtained with Method C utilizing different lots of PSMA-11 material and a germanium-68/gallium-68 generator (1.85 GBq) at the end of shelf life (left data), at the start of shelf life (central data), and in the middle of shelf life (right data).
| Method C | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Generator calibration date | 2020/08/11 | 2021/06/22 | 2021/06/22 | ||||||
| Lot PSMA-11 ID 9921.0001 | PSMA-06-19091803.01 | PSMA-06-19091803.01 | PSMA-06-20120102.07 | ||||||
| Precursor reconstitution date | 2021/03/16 | 2021/06/29 | 2021/09/22 | ||||||
| Process number | Date | RCY, % a |
Radioactivity
at EOS, MBq a |
Date | RCY, % a |
Radioactivity
at EOS, MBq a |
Date | RCY, % a |
Radioactivity
at EOS, MBq a |
| 1 | 2021/03/16 | 83 | 442 | 2021/06/29 | 80 | 954 | 2021/09/22 | 80 | 772 |
| 2 | 2021/03/17 | 84 | 448 | 2021/06/30 | 81 | 961 | 2021/09/24 | 79 | 755 |
| 3 | 2021/03/24 | 79 | 416 | 2021/07/07 | 81 | 953 | 2021/09/29 | 79 | 748 |
| 4 | 2021/03/30 | 81 | 411 | 2021/07/14 | 80 | 924 | 2021/10/05 | 82 | 768 |
| 5 | 2021/03/31 | 78 | 401 | 2021/07/21 | 81 | 918 | 2021/10/06 | 80 | 740 |
| 6 | 2021/04/07 | 79 | 399 | 2021/07/27 | 82 | 909 | 2021/10/13 | 79 | 723 |
| 7 | 2021/04/21 | 79 | 387 | 2021/07/28 | 82 | 915 | 2021/10/20 | 82 | 740 |
| 8 | 2021/04/22 | 78 | 380 | 2021/08/03 | 82 | 899 | 2021/10/26 | 81 | 720 |
| 9 | 2021/05/05 | 80 | 372 | 2021/08/04 | 80 | 875 | 2021/10/27 | 79 | 700 |
| 10 | 2021/05/12 | 78 | 360 | 2021/08/31 | 81 | 826 | 2021/11/09 | 80 | 685 |
| Means | 79.9 | 401.6 | 81.0 | 913.4 | 80.1 | 735.1 | |||
| SD | 2.13 | 28.62 | 0.82 | 40.77 | 1.20 | 28.23 | |||
| Between Groups | Within Groups | ||||||||
| SS-Sum of squares | 6.8667 | 59.8000 | |||||||
| DF-degrees of freedom | 2 | 27 | |||||||
| MS-Mean square | 3.4333 | 2.2148 | |||||||
| Fisher F | 1.5502 | ||||||||
| p-Value | 0.2305 | ||||||||
a Non-decay corrected.