What Is A Significant Change In Stability
A significant change instability is a deviation from its trend. According to ICH guidelines, the remarkable changes observed in the drug product considered significant changes.
Definition of Significant change:
Significant change is a remarkable change in the physical or chemical properties of the drug product or drug substance. Or
It is a noticeable change in the physical or chemical property from its initial results of the drug product or drug substance.
What is a Significant change in Dissolution?
The significant change in dissolution is, when the dissolution does not meet (Fails) to S2 stage acceptance criteria then it is considered as a significant change.
What is ICH and FDA guidelines talks on What Is A Significant Change In Stability?
- A 5% change in assay from its initial value, or failure to meet the acceptance criteria for it’s potency when using biological or immunological procedures.
- Any degradation products exceeding its acceptance criterion. (Related substances)
- Failure to meet the acceptance criteria for appearance, physical attributes, and functionality test (eg. color, phase separation, Resuspendability, caking, hardness, dose delivery per actuation). However, some change in physical attributes (eg softening of suppositories, melting of creams) may be expected under accelerated conditions.
- Failure to meet the acceptance criterion for pH.
- Failure to meet the acceptance criteria for dissolution for 12 dosage unit.
- 5 % loss in water from its initial value considered a significant change.
The stability of the drug product is determined by storing the product at different intervals such as accelerated and long-term conditions.
As per ICH Q1E, when gelatin capsule and gel coated tablets fail to meet specification criteria of dissolution, it will not be a significant change, if no other significant change is observed.
Here we understand what is a significant change in Stability? What is a Significant change in Dissolution?
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