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Current Position: Home > Solution & Service

API & Intermediates
CDMO Service
Drug Product CDMO Service
Analytical Service
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Analytical Service API & Intermediates CDMO Service Drug Product CDMO Service Support
Analytical 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 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.