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Brazil – General Provisions for Stability Studies of Active Pharmaceuticals and Medicines

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Storage ConditionLong-Term or Follow-up Study*Accelerated Stability Study*
-25 ° C to -15 ° C-20 ° C ± 5 ° CThere is not
Cooling (2-8 ° C)5 ± 3 ° C25 ° C ± 2 ° C / 60% RH ± 5% RH or30 ° C ± 2 ° C / 75% RH ± 5% RH or30 ° C ± 2 ° C / 65% RH ± 5% RH
Controlled ambient temperature (between 15 ° C and 25 ° C)25 ° C ± 2 ° C / 60% RH ± 5% RH40 ° C ± 2 ° C / 75% RH ± 5% RH
Ambient temperature (between 15 ° C and 30 ° C) – protect from moisture30 ° C ± 2 ° C / 70% RH ± 5% RH30 ° C ± 2 ° C / 65% RH ± 5% RH40 ° C ± 2 ° C / 75% RH ± 5% RH
Ambient temperature (between 15 ° C and 30 ° C)30 ° C ± 2 ° C / 75% RH ± 5% RH40 ° C ± 2 ° C / 75% RH ± 5% RH
Storage ConditionLong-Term or Follow-up Study*Accelerated Stability Study*
-25 ° C to -15 ° C-20 ° C ± 5 ° CThere is not
Cooling (2-8 ° C)5 ± 3 ° C25 ° C ± 2 ° C / 60% RH ± 5% RH or30 ° C ± 2 ° C / 75% RH ± 5% RH or30 ° C ± 2 ° C / 65% RH ± 5% RH
Ambient temperature (between 15 ° C and 30 ° C) – water based products30 ° C ± 2 ° C / 35% RH ± 5% RH40 ° C ± 2 ° C / 25% RH ± 5% RH
Ambient temperature (between 15 ° C and 30 ° C) – other products30 ° C ± 2 ° C / 75% RH ± 5% RH40 ° C ± 2 ° C / 75% RH ± 5% RH

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