Disregard limit & Method Validation

[Milosh]

Hi!
I am validating analytical methods onto HPLC and UPLC, and I have one question.
I validate Pharmacopeiae HPLC method for impurities in which solution for disregard limit is given. Does it mean, that LOQ=disregard limit conc? Practicaly yes, but what should I have to test under LOQ and LOD determination, and Repeatability onto LOQ, also???

Regards!

Milosh

[bartjoosen]

Please take a look at the ICH guidelines:
http://www.emea.europa.eu/pdfs/human/ich/038195en.pdf
(p 12)

This will provide you with some approaches.