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. 2020 Jul 1;5(27):16556–16561. doi: 10.1021/acsomega.0c01250

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
a

Temperature excursion on batch 1003-H was assessed to be a minor deviation caused by a failure of a temperature control module.