From: CMC development of [14C]-labeled sotorasib for the conduct of microtracer human ADME study
Test | Criteria | Result |
---|---|---|
Radiochemical purity by HPLC-beta ram detector | ≥ 96.0% area Any single impurity ≤ 2.5% area | 98.1% area All single impurities ≤ 2.5% area |
Assay (as is) by HPLC-UVa | Report (%w/w) | 89.8% w/w |
Specific activity by LSC | Report (µCi/mg) | 99.3 µCi/mg |
Chemical purity by HPLC-UVa | ≥ 96.0% area | 99.2% area |