Study Set Content:
Type of
dosage form
Container/closure system used for
packaging and light
Heat and moisture conditions encountered during
shipment, storage and handling.
at relatively high temperatures and/or humidity
accelerated stability testin
In early stages, accelerated stability testing (at relatively high temperatures and/or humidity) is used in order to determine the type of degradation products which may be found after
long-term storage
Normally performed for longer duration of the test period in order to allow significant product degradation under recommended storage conditions.
Real Time Stability Testing
- A product is stressed at several high (warmer than ambient) temperatures and the amount of heat input required to cause product failure is determined.
Accelerated Stability Testing
This is done to subject the product to a condition that accelerates
degradation
This information is then projected to predict shelf life or used to compare the relative stability of
alternative formulations.
This usually provides an early indication of the product shelf life and thus shortening the
development schedule
The concept of accelerated stability testing is based upon the
Arrhenius equation
Arrhenius equation
lnK =lnA +change in E/RT
ln
natural log
K
degradation rate/s
A =
Frequency factors
change in E
activation energy (kj/mol)
R
universal gas constant (0.00831 kJ/mol)
T
absolute temperature (K)
This equation describes the relationship between storage temperatures and degradation rate
Arrhenius equation
A usual practice for every marketed product for which stability data are required. In this study, stability samples, for retained storage for at least one batch a year are selected.
Retained Sample Stability Testing -
