Disregard limit & Method Validation
Posted: Tue Mar 18, 2008 8:48 pm
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
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