Table 4. Process Efficiency Comparison (Chromatography vs Classical Resolution).
| Metric | Chromatographya | Resolutionb |
|---|---|---|
| PMIc | 942 | 113 (↓88%) |
| Solvent used | 817 L | 118 L (↓86%) |
| Yield (2-step)e | 39% | 39% |
| Processing time | 36 days | 14 days (↓61%) |
Data based on a clinical chromatography process not optimized for commercial production.
Includes solvent contributions from free-basing/crystallizing free (M)-6.
Process mass intensity relative to sotorasib drug substance.
Total solvent used per kg of (M)-6 produced.
Yield after crystallization (chromatography) or free-basing/crystallization (resolution).