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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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