Doped materials for reversed-phase chromatography.

摘要

A material for reversed phase chromatography comprising surface-modifying non-polar and charged groups, which are bound to a solid support, wherein the charged groups in amounts of from about 0.25 to about 22% are present on the surface modifying groups, or in amounts of about 0.01 .mu.mol / m 2 to 0.8 micromol / m 2 based on the surface of the solid support for a material having a total amount of surface-modifying groups of 3.6 micromol / m 2. Such a material and suitable purification conditions for active pharmaceutical ingredients (APIs), such as peptides, can be evaluated by (a) determining the isoelectric point (pI) of interest API, (b) selecting a pH in a range in which the material of the is solid phase stable, (c) determining the difference pI - pH and (d) if the difference pI - pH is positive, selecting a anion exchanger (aIex) material, or if the difference pI - pH is negative, selecting a cation exchanger ( CIEX) material.