Evaluate impurity spectra of the process route according to the ICH Q3 and M7, study and determine the thresholds of process impurities, degradation impurities, residual solvents, elemental impurities and genotoxic Impurities.
● Genotoxic Impurities (GTI) Analysis(ICH M7)
● Elemental Impurities Analysis(ICH Q3D)
● Residual Solvents Analysis(ICH Q3C)
● Process Impurities and Degradation Impurities Analysis(ICH Q3A/Q3B)
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