Molecular Building Blocks
Impurity profile studies: Organic impurities, Inorganic impurities, Elemental impurities, Residual solvents, Degradation impurities, Potential genotoxic impurities.
Impurity synthesis, Structure identification and Impurity calibration: Synthesis and structure characterization by Single crystal X-ray diffraction(s-XRD), Microcrystalline electron diffraction (MicroED) ect.
Impurity limit studies: Determination for impurity limits of each intermediate through impurity source analysis/clearing/spiking and degradation studies; determination of API’s impurities and impurity content based on safety risk assessment
Genotoxic impurity studies: Genotoxicity prediction of impurities based on (Q)SAR (Derek&Sarah or Toxtree software);
Genotoxicity risk assessment using bacterial reverse mutation experiments (Ames tests) for high-risk impurities;
Limits calculation for genotoxic impurities based on ICH M7 guidelines