Page 174 - Applied Pharmacognosy
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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
