By Anonymous on Thursday, September 11, 2003 - 02:32 pm:
Hello,
Would appreciate if someone could please explain how to calculate the limit of quantitation of an impurity using calibration curves. It seems to me that more than one calibartion curve is needed because the stadard deviation of the y-intercepts is needed. If it is the case, then which slope should be used, average? How many calibration curves are needed?
Many thanks in advance!
By Anonymous on Friday, September 12, 2003 - 12:23 am:
According to ICH validation guideline quantitation limit is 10*S/s (S slope of calibration funktion, assuming that ti is linear, s residual standard deviation of calibration function).
to be found at www.ich.org under Q2...
what formular are you using?