Figure 4: Bioanalytical tests for the parameters of product amount on basis of physicochemical and immunological characteristics. Advantages (in green), disadvantages (in red) and “neutral” criteria on the basis of the criteria for target qualification are given for reverse phase HPLC (Eclipse XDB C8; 80A pore size, isokratic, 1 ml/min, 40 mM sodium phosphate, pH = 3.7, 85% phosphoric acid, 24% acetonitril, excitation 276 nm, emission 306) and radioimmunoassays (displacement curves with immobilised monoclonal antibody, [125I] insulin, SDStreated samples) as exemplified for some insulin variants (symbols see Figure 1). Some alternative methods are listed at the bottom.