Analytical Method Development

Service Description

Analytical methods are often developed under ideal conditions, but exhibit unexpected variability in routine operation. Approach Using DoE, methodological factors are systematically varied in order to quantitatively assess robustness and critical factors. Result Identification of critical method parameters Quantitative robustness assessment Data-driven basis for method validation Added value Reduced out-of-specification (OOS) events More stable QC processes Support for regulatory requirements in accordance with ICH Q2 Analytical Validation