International Conference of Harmonization (ICH) document

Harmonized tripartite guideline; validation of analytical procedures: text and methodology Q2(R1). Geneva, CH: ICH 2005”.

 

Accuracy

The accuracy of an analytical procedure expresses the closeness of agreement between the value that is accepted either as a conventional true value or an accepted reference value and the value found

 

Precision

The precision of an analytical procedure expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions

 

Linearity

The linearity of an analytical procedure is its ability (within a given range) to obtain test results that are directly proportional to the concentration (amount) of analyte in the sample

 

Specificity

Specificity is the ability to assess, unequivocally, the analyte in the presence of components that may be expected to be present

 

Limit of Detection

The LOD of an individual analytical procedure is the lowest amount of analyte in a sample that can be detected but not necessarily quantitated as an exact value

 

Limit of Quantitation

The LOQ of an individual analytical procedure is the lowest amount of analyte in a sample that can be quantitatively determined with suitable precision and accuracy

 

Robustness

The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability during normal usage

 

Stability

The ability of a standard or sample preparation solution to meet method specifications over time