System suitability

[mojo]

What does we all be doing for the system suitability? For isocratic, we do the precision and the resolution and the plates. For gradients we no did the plates.

[JGK]

We duz the precision of the peak area/height and RT

occasionally we may include:

USP tailing;
Resolution (if > single analyte)

Never much more than that.

[Dan]

For the pharmaceutical industry, the EP and USP set the standards: you need to evaluate for precision, tailing and resolution. And the FDA and the EMEA (and other agencies) will expect to see those three.

The USP does state that it is acceptable to use plates in place of resolution, but usually resolution is used (see the USP for its reasons).

Search the forum for discussions about plates in gradients.

If you are doing impurity analysis, then you may also need to have a requirement for the QL/DL. The USP was considering adding a requirement for this (they referred to it as the "Detector Sensitivity"), but the implementation of that requirement has been postponed. However, the EP does have a similar requirement already.

Regards,
Dan

[mojo]

Do you do the resolution and PT at the beginning and end of the run?

[Terry]

The USP was considering adding a requirement for this (they referred to it as the "Detector Sensitivity"), but the implementation of that requirement has been postponed. However, the EP does have a similar requirement already.

Dan,

I have tried to find these requirements for some time, would you please have this referenced?

Thanks in advance.

Terry

[Dan]

Terry,

Here is the link to the USP notice of postponement:

http://www.usp.org/USPNF/notices/postpo ... er621.html

In that notice they state:

"detection sensitivity under System Suitability that is published on page 2647 of USP 29–NF 24 and slated to become official on June 1, 2006".

I can't give a link to that document as the USP does not provide it free online. You will need to get the printed text or an online USP subscription.

Regards,
Dan

[Terry]

I got it

Thanks, Dan.

Terry