Bioequivalence and Bioavailability Forum

Good morning,

To stablish the System Suitability Test SOP based only on scientific article reserch , I found some difficulties to inderstand some details and that is why I need your help please,

here is some of my questions:

1/ To realize this SST, I choose a aqueous mixture solution of the analyte and et Internal Standard (IS), but for the concentration, do I have to choose the concentration of the lowest point of the calibration curve or an approximately middle concentration of the calibration curve of the analyte and working concentration of IS??

2/ For the calculation of RSD %:
- Is the RSD % of the analyte/IS ratio calculated?
- Or the RSD % of each peak calculated separately ?

3/ What should be the acceptance criteria for the RSD% ??

4/ can we be satisfied with the injection of the SST solution only at the beginning of the RUN or is it mandatory to add another one in the middle of the run?

5/ What should be the acceptance criteria of the signal to noise parameter in SST?

Thank you in advance for your precious help.

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Edit: Category changed; see also this post #1. [Helmut]