impurity LC methods.. linearity range? accuracy?

[alicee!]

hi all..
how do u demonstrate linearity, range & accuracy for impurity methods by chromatography?
say, for RP-HPLC for impurities, do u show range/accuracy in the impurity range only i.e. some 2-0.5% or u show linearity throughout the 100%-0.5% range? how do show accuracy or calculate recovery?

i want to know yr view points to this aspects..

thanks!

[tom jupille]

The US FDA spells it all out for you:
http://www.fda.gov/CDER/GUIDANCE/cmc3.pdf

[Rob Burgess]

thanks for the link Tom (suprised I haven't been able to find it before )!

PS. This document is dated 1994 - is there any plans to update I wonder?

[tom jupille]

PS. This document is dated 1994 - is there any plans to update I wonder?

This is the US Government we're talking about!

All joking aside, the most current specs would be from ICH, but the relevant sections of that date to 1996, and are essentially the same as the 1994 FDA guidance.

The FDA has a more general draft guidance on validation that was last revised in 2001 (http://www.fda.gov/cder/guidance/2396dft.htm), but it's shy on details and references the 1994 guidance.