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Solution & Service
API Analysis Service
  • Method developments, validations, and transfers for intermediates and APIs
  • Systematic method screening system for rapid establishment of stability-indicating assay and impurity method using UPLC-MS with 6 columns and solvent screening
  • Provide IND/NDA ready-for-filing method development reports, method monographs, and method validation reports per ICH guidelines
  • Establish impurity control strategies and specifications
  • Rapid establishment of chiral impurities / chiral purity methods (UPC2 or HPLC)
  • Methods developments for counter-ion analysis (Titration or IC)
  • Impurity structure IDs by NMR, UV, IR, TGA, DSC, HRMS, etc. Sample preparations by SFC or prep-LC with full characterizations
  • Establish analytical methods for (potential) genotoxic impurities by LC-MS or GC/MS including GC-MS/MS
  • Establish elemental impurities method as per ICH Q3D（ICP-MS）
  • Establish analytical methods for no-UV response compounds by using CAD or RID
  • Fast method developments and determinations of compound-specific residual solvents and water contents by Headspace GC systems and KF analyzer

 

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