Dera all,

We are performed Linearity of Drug product(Dissolution Method) from 0-120% of working standard concentration.

we have established r2 > 0.999.but we have additional acceptece criteria such as

  1. Residual(y-intercept at concentration 0) is NMT +/- 2% of lebel claim.
    2)Sum of residual squares and residual(y-intercept at concentration 0)

pl. advice me how to calculate and establish the acceptence criteria of 1) and 2).
and provide me any formula or excel spread sheet.



Residual error in regression: [Y- intercept*100]/ [Response @Target conc ]

you may search publication: preparation of calibration curves: a guide to best practice from


Please check this link

Srikanth N