my question is about the place of system suitability test in developing and validating a New analytical UPLC Chromatography method.
its places is considered as a step in the analytical validation or we can assess the suitability test between development and validation or we should evaluate it before those steps.
an other question how we should prepare our standard to make the suitability test
Hi Yassine,
Firstly, system suitability test should be performed as a first step before you begin method validation/development. This is because only via system suitability you can ensure whether or not your method can be used for the particular marker on the particular system.
Secondly, never prepare the standard solution for your system suitability directly from the compound. First prepare a stock standard solution and then prepare the required concentration of the standard from that stock solution. This will help you to use the same stock solution for preparing other concentrations too if in case any one concentration is not responding better in the instrument.
I hope its cleared.
Thanks
Regards
Hi Yassine,
Ideally, your standard stock should cover at least several retention time points, as this will give you also a benefit of monitoring column performance in a longer perspective. Material for suitability test shouldn't be also too complex. What compounds class you are working on?
Cheers,
Janusz
Dear, Janusz
I don't understand what do you mean with Cover at least several retention time points
I have other questions:
- How to Get perfect peaks : System suitability for UPLC ?
- There is any guideline to pursue?
I Found in many articles that to obtain a good (SST) we must have a :
Resolution > 2.0
—relative standard deviations—of peak response and retention time
Dear Yassin,
I would appreciate a vote, if my answer was helpful to you.
Thanks
Sachin
System suitability is used to demonstrate that your instrument of analysis is suitable for the analysis of the target molecule. Thus, it is regularly used by QC. As pointed out above it is part of method development and applies only to the standard.
Typically, for an assay the system suitability is a %RSD of 2.0% or less (5 injections) and 5.0% or less for a related substance (6 injections since the concentration is very low, sub ppm or even ppb). See the requirements for pharmaceuticals in USP section .
Yassine,
Resolution is a different issue than system suitability though both can be used as an 'acceptance criteria' to demonstrate that the instrument/sequence is/are acceptable.
Typically, baseline resolution between critical pairs (API and one of its impurities) is mathematically demonstrated when the result is 1.5 though many companies view 1.8 or higher is sufficient. See the Waters and/or Agilent websites for the equation.
Bruce,
Thank you for your answer about RSD % of 6 injection
if we consider that system suitability as 'an acceptance criteria' then we can consider it as a criterion of analytical validation, or in my project I worked on tow steps which are development and validation
I found in many articles that SST can be often placed between the two steps even their is an other works who place it before
my question is if i should share it in my work should it add some information my work or can avoid it
You should put in your work/sequences (analytical method validation I presume). This will prevent a reviewer to question the results and conclusions.
Remember, it was in HPLC development that the 'acceptance criteria' (system suitability) was developed.
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