Mahesh
●    

2007-01-12 08:59
(7083 d 07:52 ago)

Posting: # 451
Views: 7,747
 

 Stability (in Matrix) [Bioanalytics]

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For Stability calculation in Matrix, can we compare the Back calculated concentratiion of stability samples with its Theoretical concentrations instead of Fresh samples concentration or day Zero concentrations.

Regards

Mahesh.
 
paresh.mistry
●    

2007-01-12 12:52
(7083 d 04:00 ago)

@ Mahesh
Posting: # 455
Views: 6,028
 

 Stability (in Matrix)

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Dear mahesh,

for the LT stability you have to compare your sample concentration against back calcuation with first day of the stability.
there is not other alternative due to you are prooving the stablity against your produce result.

regards,
paresh
 
Jaime_R
★★  

Barcelona,
2007-01-12 16:00
(7083 d 00:52 ago)

@ Mahesh
Posting: # 457
Views: 5,981
 

 Stability (in Matrix)

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Dear Mahesh,

see http://www.fda.gov/cder/guidance/4252fnl.pdf FDA's Guideline (IV. METHOD DEVELOPMENT: CHEMICAL ASSAY, D. Stability, 2. Short-Term Temperature Stability and 3. Long-Term Stability).

Edit: Link corrected for FDA’s new site. [Helmut]
—
Regards, Jaime
 
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