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Can any one please explain following questions?
1. If product charged for stability at 40*C/75%RH - accelerated &
30/75 - long term, if product fails at acclerated conditions, what is
back up data for accelerated study?
2. Do we need to conduct at 30/65 - 12M or 25/60 - 12M for
submission.?
Regards,
Devang Purohit
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Hi Devang,
If your current long term stability test (30*C/75%) complies with your
specifications and you have some samples stored at 5*C +/- 3*C, you
might state that 25*C +/- 2*C/60% RH +/- 5% is your accelerated
storage condition and 5*C +/- 3*C your (real-time) long term storage
condition. Otherwise, you will have to perform all the long term
stability test at 25*C/60*C over 12 months with 30*C/65* as
intermediate storage condition (with a minimum of 4 time points)
before submission to the FDA. You might also choose to test your
sample at just 30*C/65*C over 12 months if you select this temperature
as the long term storage condition instead of 25*C/60*C.
Hoping this will help,
Fanny
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