Chromatography Forum

Posted: **Fri Jul 30, 2010 9:08 pm**

Hi all,

In the valiadation of a stability-indicating assay and impurities methods,
what acceptance criteria do you all normally apply to robustness results? Also, do you normally evaluate wavelength as part of robustness testing, and if so, what range do you usually evaluate (e.g., +/- 2 nm)?

Thanks!

Posted: **Sat Jul 31, 2010 2:12 pm**

Hi all,

In the valiadation of a stability-indicating assay and impurities methods,
what acceptance criteria do you all normally apply to robustness results? Also, do you normally evaluate wavelength as part of robustness testing, and if so, what range do you usually evaluate (e.g., +/- 2 nm)?

Thanks!

WV is not included. It should be calibrated routinely in PM, PQ.
I was wrong, how about 2% variation?

Chromatography Forum

Robustness testing - wavelength variation

Robustness testing - wavelength variation

Re: Robustness testing - wavelength variation