Method validation, precision and Accuracy

[cody84]

Hi I'm just wondering what everyone does for intermediate precision, specifically what statistical analysis do you perform on the data from 2 labs on the same sample?

My other question is; what are the guidelines for recovery? I've read that recovery specifications should depends on the concentration of the analyte, but am having a hard time matching this up to any regulations, which would help me greatly.
I've performed accuracy and range 3 different ways on my method and always get a recovery of 95% (woohoo consistent) across all levels. My active is 0.23%.

[krickos]

Hi Cody

Seems like your recovery is just fine considering % concentration. There is no worldwide agreeed guideline on recoveries however as you say one should fit requirement depending on concentration.

Australia has a guideline with such recommendations, I have attached a link to their validation guideline, should serve as a good starting point.
http://www.apvma.gov.au/publications/gu ... ethods.pdf