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Types of Chemical markers

Stability Testing Frequency

Study           Storagecondition      Minimum time period
Longterm*                             covered by data at
                25°C ± 2°C/60%RH      submission
Intermediate**  5%RH or           ± 6 months(optionaandb )
Accelerated**   30°C ± 2°C/65%RH
                5%RH              ±

                30°C±2°C/  65%RH± 6 months
                5%RH

                40°C ± 2°C/75%RH ± 6 months
                5%RH

performed at 25°C ± 2°C/60%RH ± 5%RH or 30°C ± 2°C/65%RH ± 5%RH. In
the latter case, no additional data under intermediate conditions will have to be
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