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Table 2 [14C]-1 clinical AMG 510 drug substance results

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

  1. aHPLC-UV analysis was performed at 256-nm wavelength