Mahesh
●    

2007-01-12 09:04
(7108 d 15:17 ago)

Posting: # 452
Views: 7,967
 

 Stability (Stock Solution) [Bioanalytics]

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For Stock solution stability at Room Temperature , can we compare stability Solution at Room temperature with refrigerated solution instead of preparing fresh solution.

i.e prepare a Stock solution and aliquot it into two portions, one portion kept at Room Temperature and the other at 2-8°c. After xx hours inject these solutions into a HPLC/LCMS instrument and compare their response , if they were within the desired stability limit, can we say that the stock solution is stable at Room Temperature for xx hours
 
paresh.mistry
●    

2007-01-12 12:42
(7108 d 11:40 ago)

(edited on 2007-01-12 13:26)
@ Mahesh
Posting: # 453
Views: 6,124
 

 Stability (Stock Solution)

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Dear mahesh,

you have to prepare fresh stock solution to proven you desire time of stability against your stock solution which you want to proven as per my understanding.

expert can comment.

regards,
paresh
 
Jaime_R
★★  

Barcelona,
2007-01-12 16:01
(7108 d 08:20 ago)

@ Mahesh
Posting: # 458
Views: 6,199
 

 Stability (Stock Solution)

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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, 4. Stock Solution Stability).

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