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HPLC System suitability
Posted: Wed Oct 10, 2007 10:28 am
by grreddy
Dear Friends,
Can any one tell me about the System Suitability parameters that is RSD limts for HPLC,GC etc.. articles where i can get.
thanks in advance
g.r.reddy
Posted: Wed Oct 10, 2007 2:10 pm
by Shanextan
USP's general requirement is 2%.
Posted: Thu Oct 11, 2007 1:06 pm
by DR
In the Pharmaceutical industry, ^ for assays, generally it's 2%. For low level impurity standards etc., it is frequently 5%. There are many references on the topic. As usual, it largely depends on what you are running (Blend or Content Uniformity, Composite Assay, Release etc.).
For other industries, compendial specifications vary, generally as a function of anticipated concentrations and the test methodology (and sample prep) employed.
hai friends
Posted: Fri Oct 12, 2007 6:02 am
by grreddy
is there any published articles on that
Posted: Mon Oct 15, 2007 3:28 pm
by wanda50
USP-NF General chapters chromatography <621> System suitability