Table 3: Stability of [14C]-Compound B API (16.6 μCi/mg).
Time point at -80 ℃, week | Chemical purity, % | Largest chemical impurity, % | Radiochemical purity, % | Largest radiochemical impurity, % |
---|---|---|---|---|
Initial | 99.9 | 0.1 | 99.4 | 0.2 |
7 | 99.5 | 0.2 | 99.0 | 0.3 |
11 | 99.1 | 0.3 | 98.9 | 0.3 |
14 | 98.8 | 0.3 | 98.1 | 0.5 |
18 | 98.6 | 0.4 | 98.0 | 1.1 |
22 | 98.6 | 0.5 | 97.6 | 0.7 |
26 | 98.5 | 0.7 | 97.2 | 0.9 |