Table 5 AMS-based stability study results
From: CMC development of [14C]-labeled sotorasib for the conduct of microtracer human ADME study
Test | Criteria | T0 | T24h | T48h | Clinical site T24h |
|---|---|---|---|---|---|
Appearance | White, opaque, well dispersed suspension | Conforms | Conforms | Conforms | Conforms |
Radiochemical Purity | Radiochemical purity: ≥ 96.0% area Any single unspecified impurity ≤ 2.5% area | 98.7% All impurities <2.5% | 99.1% All impurities <2.5% | 98.4% All impurities <2.5% | 99.1% All impurities <2.5% |
Radioactivity Concentration | Target 1.0 µCi/dose | 1.0 µCi | 1.0 µCi | 1.0 µCi | 1.0 µCi |