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FAQs

How to Control Impurities in Pharmaceutical? To What Extent are Impurities Controlled?

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%