Pharmaceutical Research

Pharmaceutical Research

Impurity studies

  • 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
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