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

Q: 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 single impurity • Safety assessment batch: purity 97.5%, the maximum single impurity control within 1.0%. • Pilot batch: purity 99.0%, specific impurity control is less than the safety assessment batch, unknown single impurity 0.10% • Clinical batch: purity 99.0%, specific impurity control is less than the safety assessment batch, unknown single impurity 0.10%

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Accepted Answer

•Laboratory scale batch: purity 98.0%, with no significant impact on the limit of single impurity

• Safety assessment batch: purity 97.5%, the maximum single impurity control within 1.0%.

•Pilot batch: purity 99.0%, specific impurity control is less than the safety assessment batch, unknown single impurity 0.10%

•Clinical batch: purity 99.0%, specific impurity control is less than the safety assessment batch, unknown single impurity 0.10%