HPLC System suitability

[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

[Shanextan]

USP's general requirement is 2%.

[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.

[grreddy]

is there any published articles on that

[wanda50]

USP-NF General chapters chromatography <621> System suitability