Current Position: Home > Solution & Service > Analytical Service
Current Position: Home > Solution & 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 report, method monographs, and method validation reports per ICH guidelines
* Establish impurity control strategies and specifications
* Rapid establishments 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) geno-toxic 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.