how to define Range and Linearity
Posted: Wed Mar 07, 2012 6:21 am
Hi to all can any one explain me how to define Range and Linearity in validation.
Linearity is normally related to a calibration curve, it is a range of concentrations for which the responses can be fitted to a linear function of a certain defined qualities.
Range is the interval of concentrations to which the method is applicable. If the method should give 70-140% recovery and 35% RSD of duplicates, then the range is the interval of concentrations where these characteristics will be routinely achieved all the times, e.g. range - LOD-ULL for Bisphenol A in oil from 10 ppb to 100 ppm by a method “A”.