By om on Tuesday, August 26, 2003 - 08:07 am:
In the general chapter on chromatography of European Pharmacopoeia a requirement is set for maximal permitted RSD of replicate injections of the same solution, which should not exceed the values given in table 2.2.46-1.
I would like to know if anybody knows a literature reference about the requirements for RSD of the analysis of different solutions, that is, taking into account the variability of solutions preparation (which is, I think, a much more common situation in quality control).
Thank you all
By Jan on Sunday, August 31, 2003 - 11:19 pm:
If you find 5 literature references, you'll find 5 different RSDmax values....
I work in QC as well, we follow EP, and we have in-house maximum allowable RSD values for assay.
They depend both on number of samples taken from a homogeneous preparation (n) and on the assay specifications (B=upper specification limit -100).
For instance, 3 samples taken from a preparation where 95-105% limits apply, give you a maximum RSD of 1.95 %; 2 samples from a 90-110% preparation: maximum RSD 1.50 %.
Note that this should be seen as part of a broader Out Of Specification SOP.
Jan