Develop, validate, and troubleshoot HPLC and GC analytical methods
Perform intermediate process control.
Perform cleaning validation.
Oversee final product and stability sample.
Conduct TFDA and European customers audit.
Train new employees.
Project :
Anti-cancer medicine Fulvestrant - GC method development and validation
Content : Used GC to establish a reliable analysis method to determine whether the organic residual solvent content in the product meets the standard.