chiral chromatography validation

[martinamarie]

Hi, would a stress study be required for validation of a chiral chromatographic method.
Thanx
Tina

[tom jupille]

I would think that depends more on the purpose of the method than on whether or not it's "chiral".

[krickos]

hmmm

Well if your product is a racemate I would guess no. however if your going to analyse a enantiomer pure drug substance/product it may get intresting.

I have a enantiomer pure drug substance that if I heat treat it "right" I will get more of the wrong enantiomer, on top of things the final product is heat stearlilazed so in this case stress studies was intresting.