Japanese–English glossary
Characterization
特性解析tokusei kaiseki
Also written キャラクタリゼーション、特性解析（キャラクタリゼーション）
Detailed analysis of a product's structure and properties with methods of higher resolution than routine release testing: primary and higher-order structure, glycosylation, charge and size variants, post-translational modifications, biological activity and impurities (ICH Q6B). Characterization data justify the specification, support comparability after process changes and help deviation investigations. Japanese documents also use the loanword for characterization. Characterization methods are not always validated to release-test standards, but they must be shown to be suitable for their purpose.