Table 2 Results of validation of HPLC versus ITLC (presented as 100% minus impurity B)
Sample | Percentage of Ga-68-DOTA-NOC (HPLC) | Percentage of Ga-68-DOTA-NOC (ITLC 1) | Percentage of Ga-68-DOTA-NOC (ITLC 2) |
|---|---|---|---|
Validation 1 | 98.2 | 98.3 | 98.5 |
Validation 2 | 98.1 | 98.0 | 98.3 |
Validation 3 | 98.7 | 99.2 | 98.5 |
Spike 5% | 93.7 | 94.5 | 91.4 |
Spike 10% | 89.5 | 89.9 | 89.6 |
Spike 15% | 84.8 | 85.2 | 87.6 |