Robustness and System Suitability - Analytical Validation - page 88

FIgure 5.3b ( Continued ) Example experimental conditions that might be used for a PB
design for an eight-factor HPLC experiment. Figure 5.3b the suggested experimental design
and conditions for the twelve chromatographic runs.

tAble 5.2
example robustness Factor selection and limits for
an Isocratic method

Factor limit range (±)

Organic solvent concentration 2%-3%

Buffer concentration 1%-2%

Buffer pH (if adjusted) 0.1-0.2 pH units

Temperature 3°C

Flow rate 0.1-0.2 mL/min

Wavelength 2-3 nm for 5-nm bandwidth

Injection volume Injection type and size dependent

Note: These limits are examples only and should be chosen according
to expected laboratory and instrument variations.