Analytical Assay Procedure Identification Testing for Impurities Characteristics   Quantitative Limit Content Potency - + - + Accuracy - + - + Precision         Repeatability - + - + Intermediate -   + 1   Precision         Specificity2 + + + + Detection Limit - -3 + - Quantitation Limit - + - + Linearity - + - + Range - + - + - Signifies that this characteristic is not normally evaluated + Signifies that this characteristic is normally evaluated 1In cases where reproducibility has been performed, intermediate precision is not needed 2Lack of specificity of one analytical procedure could be compensated by other supporting analytical procedure(s) 3May be needed in some cases

Table 8: Validation requirements from ICH validation of analytical procedure.