ICH - Stability studies, alternate conditions...

[v9991]

as per ICH, most common recommended stability conditions include 25/60, 30/65, 40/75 (Temperature/Relative Humidity)
it also provides some alternative conditions(temperature) for specific products, viz., refrigerated, frozen etc.,

now, the question is, can we similarly justify the alternate conditions for Relative humidity as well. for eg., for a glass-ampoul (/hermetically sealed) injectible product, the relevance of relative humidity can be not totally relevant. Hence, can we take exception or alternate conditions of RH (viz., charge the product only at 25-deg or 40-deg etc.,)

can we extend the similar logic to any container which is proven suitabaly to be impermeable to moisture/water vapor et.c,

 

[v9991]

as per WHO Technical Report Series 953 ... 43rd report
WHO Expert Report Committee, on specifications & Pharmaceutical Preparations.
2.2.6.2 FPPs packaged in impermeable containers
"Thus stability studies for products stored in impermeable containers can be conducted under any controlled or ambient relative humidity condition."
criteria for establishing permeability....

"Parameters required to classify the packaging materials as permeable or impermeable depend on the characteristics of the packaging material, such as thickness and permeability coeffi cient. The suitability of the packaging material used for a particular product is determined by its product characteristics."

http://whqlibdoc.who.int/trs/WHO_TRS_953_eng.pdf



Containers generally considered to be moisture impermeable include glass ampoules.
other interesting ref....http://www.who.int/medicines/areas/quality_safety/quality_assurance/StabilityTable2.pdf

note : added....to acknowledge the original contributor....