UV acceptance criteria (limits) for Accuracy parameter

[saipraveen7]

Hi!
Can anyone guide me on the acceptance criteria (limits) for Accuracy parameter in method validation for a formulation containing 0.1% of drug by UV-Visible Spectrophotometer

-P.Sai Praveen

[Consumer Products Guy]

FDA ORA guidelines are 95.0 to 105.0% accuracy.

My question is how you are going to demonstrate that your assay is stability-indicating, as a degradation product could still contribute UV absorbance.

Ask about specificity as well.

[saipraveen7]

Hi!
Could you please provide me the link for the FDA ORA guideline for analytical validation