Pharmaceutical study

Pharmaceutical research

Impurity studies

  • Impurity spectrum studies: organic impurities, inorganic impurities\elemental impurities, residual solvents, degradation impurities, potential genotoxic impurities
  • Impurity synthesis, identification and calibration: synthesize and calibrate impurities by impurity spectroscopy, microcrystalline electron diffraction Micro ED and other targeted impurities
  • Impurity limit studies: impurity source/clearing/spiking and degradation tests to determine the impurity limit of each intermediate; determination of API impurity spectra and impurity content based on safety assessment
  • Genotoxic impurity studies: perform genotoxicity prediction of impurities using Derek, Sarah, Toxtree and assess genotoxicity by bacterial revertant mutation assay (Ames test) for high risk impurities; calculate limits for genotoxic impurities in drugs based on the rules in ICH M7.
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    Bldg. 12, No. 59 Kai Qing Rd, Pudong, Shanghai (West Campus)

    Bldg. 7, No. 509 Ren Qing Rd, Pudong, Shanghai (East Campus)

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