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RegisterBuffer Addition for Stability of drug in Matrix [Bioanalytics]
Dear All,
In a Method Validation - Plasma Preparation has been done by adding 30ml of 25% Ascorbic acid solution in 100ml plasma (i.e. 30% buffer solution in plasma). All QC & CC standards prepared as mentioned above.
Whereas during sample collection (clinical phase) 50µL of 25% Ascorbic Acid has been added to vial containing approx. 1.5ml plasma.
From the above it is evident that the % buffer added to plasma during validation and sample collection do not mimic (more variation in % buffer).
With Reference to the above:
Best Regards
IK
In a Method Validation - Plasma Preparation has been done by adding 30ml of 25% Ascorbic acid solution in 100ml plasma (i.e. 30% buffer solution in plasma). All QC & CC standards prepared as mentioned above.
Whereas during sample collection (clinical phase) 50µL of 25% Ascorbic Acid has been added to vial containing approx. 1.5ml plasma.
From the above it is evident that the % buffer added to plasma during validation and sample collection do not mimic (more variation in % buffer).
With Reference to the above:
- Please comment on the affect of quantitation of the drug during analysis of the subject samples.
- Is it required to evaluate Long Term Stability with standards (QC standards) having similar concentraion of buffer as that of subject samples?
Best Regards
IK
Complete thread:
- Buffer Addition for Stability of drug in MatrixIK 2010-05-27 10:11
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Buffer Addition for Stability of drug in Matrix Ohlbe 2010-05-27 11:35
- Matrix (validation # study) Helmut 2010-05-27 14:22
- Matrix (validation # study) IK 2010-05-28 08:01
- Matrix (validation # study) Helmut 2010-05-28 11:15
- Matrix (validation # study) IK 2010-05-28 08:01
Ing. Helmut Schütz