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chiragkhatri ★ India, 2007-12-18 10:15 (6767 d 14:55 ago) Posting: # 1388 Views: 5,207 |
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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 |
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kasi ☆ 2007-12-21 09:26 (6764 d 15:44 ago) @ chiragkhatri Posting: # 1412 Views: 4,121 |
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Dear Mr. Chirag Khatri, The stock solution of analyte to perform the stability should be freshly prepared. Best Regards, Kasi ----- Edit: Full quote removed. Please see this post! [Ohlbe] |
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chiragkhatri ★ India, 2007-12-22 06:03 (6763 d 19:07 ago) @ kasi Posting: # 1415 Views: 4,200 |
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Dear Kasi, I do agree with you regarding preparation of fresh stock for stability, means further we need to prepare aqueous spiking solutions and then spike in matrix and perform the stability experiments. Regards Chirag |
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vishal vayeda ☆ 2008-01-01 09:32 (6753 d 15:38 ago) @ kasi Posting: # 1445 Views: 4,167 |
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The guideline says to performe stability from freshly made solution it does't restrict you, if you made it by freshly spiking as you have a stability data of stock solution or you made a solution from freshly weight of the analyte. both of the case can be apply but if you have a stability of your stock solution then you can go with the freshly spike solution for further activity which can be justify. regards, Vishal Vayeda -- Edit: Full quote removed. Please see this post! [HS] |
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