EN 中文

Pharmaceutical study

Pharmaceutical research
Medicinal chemistry
Process development
Pharmaceutical study
Molecular building blocks
（under construction） Pharmacokinetics
（under construction）

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.
  • Address

    Bldg. 12, No. 59 Kai Qing Rd, Pudong, Shanghai (West Campus)

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

  • Service Hotline

    +86-21-50720228-202

  • Email

    sales@pharmaresources.cn

    We will give you reply as soon as possible.

Copyright © Copyright 2023 PharmaResources (Shanghai) Co., Ltd. (Official Website)

Reference No： 沪ICP备20013779号 Website Constructed by：Ocean Shanghai