Robustness testing - wavelength variation

[Lanon]

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!

[pph31]

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?