4. Three Process Parameters for Optimization (DoE).
| Range |
|||||
|---|---|---|---|---|---|
| Symbol | Parameter | Unit | Low | High | Justification |
| A | n-Butyllithium | Equivalents | 1.8 | 3.0 | Higher and lower equivalents have significant impact on the quality of the product |
| B | Reaction temperature | °C | –60 | –40 | Higher and lower reaction temperature has significant impact on the quality of the product |
| C | Res. time | Seconds | 0.5 | 2.0 | Residence time has impact on impurity formation, particularly for impurity 15 |