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Empower 3 - Typical PDA criteria

http://www.chromforum.org/viewtopic.php?f=4&t=51874

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Empower 3 - Typical PDA criteria

Posted: Wed Nov 15, 2017 8:45 am
by ydna1977
Hi

What is a typical acceptance criteria in empower 3 for PDA

ie

PDA data shows no evidence of coelution
The peak angle is less than the peak threshold. the match angle is less than the match threshold

typically - Peak purity match factor < 950 (other CDS)

Just trying to get wording correct

Re: Empower 3 - Typical PDA criteria

Posted: Wed Nov 15, 2017 12:45 pm
by HPLC chemist
In ICH Q3 the LOQ of a related substance should be 'Not More Than' 0.05% w/w of the API (depending on the daily dosage). Thus your purity angle should be much tighter (I used 0.9990 in my forced degradation studies).

Re: Empower 3 - Typical PDA criteria

Posted: Wed Nov 15, 2017 1:41 pm
by ydna1977
Hi ,

Thanks though I am abit confused
Peak angle > = 0.9990 ?
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