What is the connection between RSD and the spec. width. With a narrow spec width (99.0 to 100.5), do we need a tighter RSD than listed in USP (2%), the monograph doesn't specify. Also please see my message titled System Suitability in GC Message Board which I posted there by mistake. I'm new to this, any input is appreciated.
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By Tom M on Thursday, May 24, 2001 - 03:08 pm:
I think your spec and your method need to make sense in relationship to each other. Any basic quantitative analysis text will show you how to propagate errors and determine the exepcted performance for an analytical method. System suitability, and more precisely the precision portion of system suitability will help you determine one of these errors.
Your spec is +0.5% and -1.0%, assuming a target of 100%. Thus a precision criteria of +/- 1% does not make much sense. Our HP 1100's typically have a precision of better than 0.1%RSD for reasonably sized peaks and injection volumes.
If your product spec is fixed and you need an analytical method with an expected performance that is suitable for your spec you could run on modern hardware and tighten the criteria of the precision portion of system suitabiltiy. Good Luck.
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By Vaishali on Thursday, May 13, 2004 - 11:16 pm:
What is the leverage for changing chromatographic parameters of a pharmacoepial method?
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