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Dear Members,
Following is a paragraph from USFDA guidelines- Bioanalytical Method validation P.No 6 Para 2 under section stability.
"All stability determinations should use a set of samples prepared from a freshly made stock solution of analyte in the appropriate analyte-free, interference free biological matrix".
Following this statements are listed various stability experiments of FT, short and Long term stability and Post preparative stability.
Does above statment mean that at the time of performing stability experiments, a calibration curve and QC samples have to be prepared from a freshly weighed stock and spiked freshly.
Pl share your opinions on the above.
Thnaks
Chirag khatri
Following is a paragraph from USFDA guidelines- Bioanalytical Method validation P.No 6 Para 2 under section stability.
"All stability determinations should use a set of samples prepared from a freshly made stock solution of analyte in the appropriate analyte-free, interference free biological matrix".
Following this statements are listed various stability experiments of FT, short and Long term stability and Post preparative stability.
Does above statment mean that at the time of performing stability experiments, a calibration curve and QC samples have to be prepared from a freshly weighed stock and spiked freshly.
Pl share your opinions on the above.
Thnaks
Chirag khatri
Complete thread:
- Stability-Method Validationchiragkhatri 2007-12-18 09:15
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Stability-Method Validation kasi 2007-12-21 08:26
- Stability-Method Validation chiragkhatri 2007-12-22 05:03
- Stability-Method Validation vishal vayeda 2008-01-01 08:32
- Stability-Method Validation kasi 2007-12-21 08:26
Ing. Helmut Schütz