•Laboratory scale batch: purity 98.0%, with no significant impact on the limit of any single impurity.
• Safety assessment batch: purity 97.5%, with maximum control of any single impurity within 1.0%.
•Pilot batch: purity 99.0%, with specific impurity control lower than that of the safety assessment batch; unknown single impurity 0.10%
•Clinical batch: purity 99.0%, with specific impurity control lower than that of the safety assessment batch; unknown single impurity 0.10%