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Total % impurities profile; repeatbability from duplicate

http://www.chromforum.org/viewtopic.php?t=4010

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Total % impurities profile; repeatbability from duplicate

Posted: Thu May 18, 2006 2:18 pm
by Rob Burgess
When assessing impurity results by % area/area of the main peak, for duplicate preps from drug product samples what would you say constitutes “repeatableâ€

Posted: Fri May 19, 2006 3:47 pm
by tom jupille
I’d probably plump for about 0.5 - 1% for total? Is this about right? Is there any guidance on this anywhere?
In general, "suggested" repeatability for major peaks in FDA/USP/ICH is about 1%, so by implication, that sounds about right, but I'm not aware of a specific guidance for that situation.
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