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Solution & Service

Home > Solution & Service > Analytical Service > APl Analysis Service

For more information about

"API Analysis Service",

please contact our team.

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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Tel: 400-8811-828

Address: No.7, Donghai 3rd Ave., Zhejiang Provincial Chemical and Medical Materials Base Linhai Zone 317016, Linhai, Zhejiang, P.R. China

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