From: CMC development of [14C]-labeled sotorasib for the conduct of microtracer human ADME study
Test | Criteria | Result |
---|---|---|
Chemical purity by HPLC-UVa | ≥ 96.0% area | 99.7% area |
Total organic impurities | ≤ 4.0% area | 0.32% area |
Assay (as is) by HPLC-UVa | 95.0–105.0% w/w | 98.9% w/w |
Specific Activity by LSC | Report (nCi/mg) | 1.36 nCi/mg |