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Table 1 HSA [14C]-1 (high specific activity) results

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

  1. a HPLC-UV analysis was performed at 256-nm wavelength