Regulatory authorities applications overview

After a short introduction into the relevance of Impurity profiling for regulatory authorities, public health, and the pharmaceutical industry, an overview is presented based on the various modes of capillary electrophoresis that have been used in drug impurity analysis. The applications of capillary zone electrophoresis, non-aqueous capillary electrophoresis, micellar electrokinetic capillary chromatography, microemulsion electrokinetic capillary chromatography, capillary gel electrophoresis, and capillary electrochromatography are presented consecutively. 

Overview of Regulatory Environment/Background Regulatory Authorities Regulatory Requirements and Procedures Application for a Marketing Authorization (MA)... 

---