Validation question

[shadow]

When performing accuracy in an HPLC method validation each extraction is performed with 10 capsules and other methods I have seen use 10 of this or that as per protocol. Is it written somewhere (ICH, FDA) that 10 samples must be used for each extraction? can 3 or 5 be used? please point me in the direction where I can find this information in the ICH or FDA guidelines, thank you.

[JGK]

ICH http://www.ich.org/products/guidelines/ ... lines.html

FDA http://www.fda.gov/downloads/Drugs/.../ ... 122858.pdf