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Registervariation in response of the analyte and internal standard [Bioanalytics]
Dear Hale,
Well... If you have problems with the method during the study, you will have to change something in the method and this may require a re-validation !
Yes, you can try and see if it helps. Possibly also other ionisation parameters such as cone voltage / declustering potential or whatever it is called on your instrument.
Well, if it affects the ionisation significantly enough to solve your problem... Almost full validation, yes. You don't have to study stabilities again, but obviously you will have to go for matrix effects, and I would say you will also need to re-demonstrate LLOQ, precision and accuracy...
Regards
Ohlbe
❝ Also; validation was completed and this problem is occured in study so, I
❝ cannot change any of my conditions/solutions/pH.
Well... If you have problems with the method during the study, you will have to change something in the method and this may require a re-validation !
❝ By the way; I think this problem leads to ionization problem. What can you
❝ think about changing desolvation temperature and desolvation gas flow?
Yes, you can try and see if it helps. Possibly also other ionisation parameters such as cone voltage / declustering potential or whatever it is called on your instrument.
❝ And if I change desolvation temperature and/or desolvation gas flow, do I
❝ have to perform whole validation once more?
Well, if it affects the ionisation significantly enough to solve your problem... Almost full validation, yes. You don't have to study stabilities again, but obviously you will have to go for matrix effects, and I would say you will also need to re-demonstrate LLOQ, precision and accuracy...
Regards
Ohlbe
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- variation in response of the analyte and internal standard haydonat 2011-01-13 10:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- variation in response of the analyte and internal standard Helmut 2011-01-13 17:08
- variation in response of the analyte and internal standard haydonat 2011-01-15 15:16
- variation in response of the analyte and internal standardOhlbe 2011-01-15 23:09
- variation in response of the analyte and internal standard haydonat 2011-01-15 15:16
- variation in response of the analyte and internal standard Ohlbe 2011-01-13 19:14
- variation in response of the analyte and internal standard haydonat 2011-01-15 15:22
- variation in response of the analyte and internal standard NewInPK 2011-02-01 18:32
- variation in response of the analyte and internal standard Ohlbe 2011-02-02 10:22
- variation in response of the analyte and internal standard Helmut 2011-01-13 17:08
Ing. Helmut Schütz