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System suitability Equation

Posted: Tue Oct 25, 2016 7:50 pm
by gianlu
Dear all, regarding the equation of system suitability %RSD = KB*sqrt(n)/t90%, n - 1, can anyone show me why the factor k is equal to 0.6/sqrt(2) ?
thank you

Re: System suitability Equation

Posted: Wed Oct 26, 2016 9:58 pm
by tom jupille
Uhhh, I don't see a factor "k" in that equation. In fact, I'm not familiar with that equation as part of system suitability. Are you referring to Student's t-test by any chance?
https://en.wikipedia.org/wiki/Student%27s_t-test

Re: System suitability Equation

Posted: Thu Oct 27, 2016 1:48 pm
by HPLCaddict
That's the equation from USP chapter 621 which is supposed to yield the permitted %RSD for a series of injections a part of system suitability.

The full text is:
"For the Assay in a drug substance monograph, where the value is 100% for the pure substance, and no maximum relative standard deviation is stated, the maximum permitted %RSD is calculated for a series of injections of the reference solution:
%RSD = KB x sqr(n) / t(90%, n-1)
where K is a constant (0.349), obtained from the expression K = (0.6/ sqr(2) x t (90%, 5/sqr(6)), in which 0.6/ sqr(2) represents the required percentage relative standard deviation after six injections for B = 1.0; B is the upper limit given in the definition of the individual monograph minus 100%; n is the number of replicate injections of the reference solution; and t (90%, n-1) is the Student’s t at the 90% probability level (double sided) with n-1 degrees of freedom."

There obviously is an explanation for K but my statistical knowledge is too limited to interpret it :roll: .

Re: System suitability Equation

Posted: Thu Oct 27, 2016 8:02 pm
by gianlu
Thank you guys,
my doubt was and yet is about the sentence "in which 0.6/ sqr(2) represents the required percentage relative standard deviation after six injections for B = 1.0"
Why? :shock: