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UV acceptance criteria (limits) for Accuracy parameter

http://www.chromforum.org/viewtopic.php?t=23881

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UV acceptance criteria (limits) for Accuracy parameter

Posted: Fri Nov 29, 2013 2:06 pm
by 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

Re: UV acceptance criteria (limits) for Accuracy parameter

Posted: Fri Nov 29, 2013 11:41 pm
by 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.

Re: UV acceptance criteria (limits) for Accuracy parameter

Posted: Sat Nov 30, 2013 2:21 am
by saipraveen7
Hi!
Could you please provide me the link for the FDA ORA guideline for analytical validation
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