Stability studies categorisation
How many types of Stability study conditions are there and what are they?
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Stability studies is done based on storage conditions for a drug or medicine categorising by temperature and relative humidity
For now, four categories are done for stability study and called as zones
Zone-1 (Temperate), Zone-2 (Mediterranean/subtropical), Zone-3 (Hot/Dry), Zone-4 ( Hot/Humid)
The study will be done by placing the packed substances in the particular stability zone and analysis accordingly
Analysis of these stability samples is done by timely basis and is categorised as Long term and accelerated.
Meaning that the stability storage samples that are stored in their respective zonal conditions are analysed by timely period as either Long term or accelerated or both
As per information, Zone-4 is further classified into 4A and 4B based on Dry and Humid conditions