Chromatography Forum

Good morning all

I am busy validating a residual solvents method. The method will be treated as a limit test. Therefore, the following method validation parameters will be done: Specificity and LOD as per USP <1225>.

This method will be required to be transfered to our QC laboratory. Since this method has been validated as a limit test, what would be required for an AMT?
I was thinking of only requesting the Receing Lab (QC) to confirm the LOD. Would an LOD satisfy AMT requirements?

Thanks in advance.
Michael

If the sample prep is anything more complicated than a dilute and shoot, you're going to want them to repeat some sample preps from lots you've also used, in addition to demonstrating that they get acceptable LOD and suitability results. It's pretty typical intermediate precision stuff, even with limit tests.

LOD is variable depending on the analyst, HPLC, time of day... Just make the LOD acceptance criteria as 'Not More Than (NMT)....

Morning Everyone

Thanks for the suggestions.

Regards
Michael