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[RegAffairs]RE: Stability testing

Hi Stein,
The answer to you question is (assuming the product is a conventional dosage
form e.g. tablet or capsule):
Yes, product is normally stored at high humidity, but not in the
refrigerator.
The shelf-life of tablets and capsules is normally determined by storing
samples at 25C/60% relative humidity, 40C/75% RH and optionally 30C/65% RH.
If the product is unstable at 30C, then the package must be labelled  'store
below 25C'.
Other rules may apply according to the exact product in question.
Regards,
Steve Binysh
Regulatory Affairs Consultant


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