A PROCESS FOR SEPERATION OF HUMAN INSULIN ESTER FROM THE SIDE PRODUCTS GENERATED DURING ENZYMATIC CONVERSION OF INSULIN PRECURSOR TO HUMAN INSULIN ESTER.

摘要

A novel is process is used to separate human insulin ester from impurities generated during the enzymatic conversion of the human insulin precursor to human insulin ester. RP-LPLC technique using step gradient elution or linear gradient elution or a combination of the two with suitable buffers comprising salts or acids and organic solvents of varying concentrations is used to recover pure human insulin ester. The human insulin ester derived at the end of the process described in this invention is of purity level which is suitable for further purification process finally leading to human insulin of acceptable quality for preparing formulations useful for administration to humans.