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Definitions of Common Method Attributes Evaluated
Accuracy
The closeness of the test results to the true value
Precision
The degree of agreement between individual test results obtained when the method is performed repeatedly on a single, uniform sample within one test
Intermediate Precision
The degree of precision obtained when the method is performed over multiple test runs, on different days, by different analysts, using different equipment
Specificity
The ability of a method to produce accurate results for a compound of interest in the presence of other compounds expected to be present during testing (i.e. excipients)
Linearity
The degree of proportionality between the measurement taken during the method and the concentration of the compound of interest in the sample
Range
The upper and lower levels of analyte over which the method produces accurate, precise and linear measurements
Robustness
The ability of a method to remain unaffected by small changes in method parameters
Lower Limit of Quanititation
The lowest measurable amount
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