Chromatography Forum

I have a question reqarding validating accuracy parameter. Currently, the procedure specifies duplicate sample preparations and report the average.

Typically, accuracy for potency is done in three levels, triplicate preparations at each level. Since the sample preparation is duplicate, six preparations at each level is required? I don't follow this logic. Any comments? BTW, the method is for drug product, not for drug substance.

We spike placebo product at 80%, 100%, and 120% target active, triplicate preparations (so total of nine, plus placebo preparation), and inject samples three times each. Standards are injected five times each as per system suitability. For test method transfer, we use product at three active levels, to be prepared in triplicate each.

The accuracy is verified at 3 levels, 3 preps each.

If you have a SOP wich requires 2 samples preps for your routine assays, I think this has notting to do with you method validation.

So 3x3 = 9 preparations are sufficient to validate the accuracy.


Ace