Chromatography Forum

hi,
simple question for you...

I'm validating an analytical method and i'm studying accuracy.
i usually worked in a range 90-110 or 80-120 so that i had 15 data (5 data per level with 90-100-110 or 3 per level with 80-90-100-110-120).
Now i'm investigating this procedure that i learnt by my precursors but i can't find any specific information about samples number to have during accuracy studies (i refer to ICH and EMEA)...
can someone light me about this matter?


thank you in advance
Vincenzo

Vincenzo,
ICH Guideline Q2(R1) Part II Section 4 says use a three by three over the range of your assay range (in US 90-110, so I would do at least 85-115)

thank you gbalok,

i found it in "recomended data"

ICH 2A point 4 Accuracy says "Across the specified range of the analytical procedure"
They are not talking about specifications of you DS/DP. I assume with "range" the method range (point 3 of that guideline) is meant: 80-120% for assay, 70-130 for uniformity tests
alex

yes you have to performe accuracy test in your range, but 80-120 70-130 are only advices...
if you want you can enlarge it or increase levels...