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accuracy solutions concentration

Posted: Mon Mar 14, 2011 11:37 pm
by Biopharmchat
the 120% and 80% of nominal concentration for accuracy study has to be exact or approximate concentration is okay?

Re: accuracy solutions concentration

Posted: Tue Mar 15, 2011 12:02 pm
by tom jupille
I believe that's the *minimum* range over which you have to validate.

Re: accuracy solutions concentration

Posted: Tue Mar 15, 2011 1:45 pm
by Consumer Products Guy
the 120% and 80% of nominal concentration for accuracy study has to be exact or approximate concentration is okay?
I think you should target 80 and 120%. And would not need to be exact, we aren't. Usually 90-110% (or tighter) is the spec range for us anyhow for our products.