Table 5. Summary of Validation Results.
| parameter | 1002-H | 1003-H | 1004-H |
|---|---|---|---|
| batch temperature | 22–24 °C | 21–28, 3 °Ca | 22 °C |
| reaction time | 72 h | 66 h | 66 h |
| yield | 34.9% | 35.5% | 35.4% |
| mass | 4.3 kg | 4.4 kg | 4.4 kg |
| analytical results | compliant | compliant | compliant |
Temperature excursion on batch 1003-H was assessed to be a minor deviation caused by a failure of a temperature control module.