ICH guide line for Stability Study

Stability study is  required for how much time  pharmaceutical product stable

In ICH guide line stability studies required for development and lifecycle of pharmaceutical products, IND / NDA also DMF file submission activities.

Stability product in pharma various environmental factors effect such as temperature, humidity and light.

all data of stability study helpful for  retest intervals and shelf life to established.

Stability study of pharmaceutical product divided four climatic zone  

ICH Stability Zones(climatic zone)

Zone	Type of Climate
Zone I	Temperate zone
Zone II	Mediterranean/subtropical zone
Zone III	Hot dry zone
Zone IV	Hot humid/tropical zone
Zone IVb	ASEAN testing conditions hot/higher humidity

Long Term Testing Conditions

Climatic Zone	Temperature	Humidity	Minimum Duration
Zone I	21ºC ± 2ºC	45% rH ± 5% rH	12 Months
Zone II	25ºC ± 2ºC	60% rH ± 5% rH	12 Months
Zone III	30ºC ± 2ºC	35% rH ± 5% rH	12 Months
Zone IV	30ºC ± 2ºC	65% rH ± 5% rH	12 Months
Zone IVb	30ºC ± 2ºC	75% rH ± 5% rH	12 Months
Refrigerated	5ºC ± 3ºC	No Humidity	12 Months
Frozen	-15ºC ± 5ºC	No Humidity	12 Months

• Cabinets 50 ºC, 57 ºC, 60 ºC

• Storage at 2-8ºC, -20ºC, -40ºC, -80ºC

 • Photostability (ICH Options 1 & 2)

 • Specialised Conditions

• Freeze / Thaw Cycle Tests

Accelerated and Intermediate Testing Conditions

Climatic Zone	Temperature	Humidity	Minimum Duration
Accelerated Ambient	40ºC ± 2ºC	75% rH ± 5% rH	6 Months
Accelerated Refrigerated	25ºC ± 2ºC	60% rH ± 5% rH	6 Months
Accelerated Frozen	5ºC ± 3ºC	No Humidity	6 Months
Intermediate	30ºC ± 2ºC	65% rH ± 5% rH	6 Months

 Analytical testing of stability study : 

Analytical testing perform analytical laboratories as per  Schuler (product  withdrawal  Schuler[Routine time point test])

It all testing done by definite testing (which is give ADL and R&D after study of    development and validation of stability indicating methods through  technology such as UPLC-MS, LC-MSMS, GCMS, HPLC, GPC, UV-VIS, GC to identify and quantify degradation products and includes tests such as assay and impurities, excipient degradation, dissolution, hardness, UV, IR, friability, disintegration, water containt, Loss on dry(LOD)  and more)