Empower 3 - Typical PDA criteria

Discussions about chromatography data systems, LIMS, controllers, computer issues and related topics.

3 posts Page 1 of 1

What is a typical acceptance criteria in empower 3 for PDA


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
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).
Hi ,

Thanks though I am abit confused
Peak angle > = 0.9990 ?
3 posts Page 1 of 1

Who is online

In total there are 5 users online :: 0 registered, 0 hidden and 5 guests (based on users active over the past 5 minutes)
Most users ever online was 221 on Tue Jan 16, 2018 8:34 pm

Users browsing this forum: No registered users and 5 guests