INTRODUCTION

This chapter provides guidance and procedures used for characterization of biotechnology-derived articles by capillary electrophoresis. This chapter is harmonized with the corresponding chapter in JP and EP. Other characterization tests, also harmonized, are shown in Biotechnology-Derived Articles—Amino Acid Analysis, Biotechnology-Derived Articles—Isoelectric Focusing, Biotechnology-Derived Articles—Peptide Mapping, Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis, and Biotechnology-Derived Articles—Total Protein Assay.

This chapter provides guidance and procedures used for characterization of biotechnology-derived articles by capillary electrophoresis. This chapter is harmonized with the corresponding chapter in JP and EP. Other characterization tests, also harmonized, are shown in Biotechnology-Derived Articles—Amino Acid Analysis, Biotechnology-Derived Articles—Isoelectric Focusing, Biotechnology-Derived Articles—Peptide Mapping, Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis, and Biotechnology-Derived Articles—Total Protein Assay.