WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 4): Analytical Method Validation: Validation

WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 4): Analytical Method Validation
(2006; 27 pages)

Table des matières

Validation

Specificity (selectivity):

is the ability to measure unequivocally the desired analyte in the presence of components such as excipients and impurities that may also be expected to be present.

An investigation of specificity should be conducted during the validation of identification tests, the determination of impurities and assay

6.1.6 Specificity (selectivity) is the ability to measure unequivocally the desired analyte in the presence of components such as excipients and impurities that may also be expected to be present. An investigation of specificity should be conducted during the validation of identification tests, the determination of impurities and assay.