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Impurity Control

WuXi’s analytical laboratories provide comprehensive analytical services for impurity control, including impurity identification, characterization and separation, structure elucidation, toxicity and genotoxicity evaluation as well as a full methodology study for different kinds of impurities.

+ Stability-indicating impurity method development and validation through column screening and QbD concept
+ Preliminary impurity identification LC-MS/TOF and/or LC-MS/MS
+ Impurity isolation by preparative HPLC/SFC and impurity synthesis
+ Structure elucidation and impurity identification by spectroscopic analysis such as NMR, IR and MS
+ Potential genotoxic impurity evaluation through software and Ames test
+ Genotoxic impurity method development / validation and control with LC-MS/LC-MS-MS, GC-MS/GC-MS-MS, ICP-OES/ICP-MS