MT 46.3 Accelerated Storage Stability MR formulation
Content Handbook P
Method - see CIPAC Handbook J, page 128
Outline of method
A sample is placed in a sheet of aluminum foil, which is subsequently wrapped in and placed in an oven at a specified temperature for a defined period of time.
The objective is to simulate the normal long-term ageing of a formulation by heating. Although actual data from a product in sales packs and stored in e.g., warehouses is preferable, the accelerated storage test provides useful guidance on performance after storage since many formulations that perform poorly in the accelerated test do not have satisfactory shelf lives (of at least 2 years) in hot or temperate climates.
The method is suitable for accelerated storage stability of matrix release formulation (MR) incorporated type regarding determination of active ingredient content and release/retention rate. It is not suitable for accelerated storage stability of MR incorporated type regarding determination of physical tests.