Stability Studies
Stability studies gauge the preservation of a product's properties and characteristics within defined parameters, ensuring consistency from the moment of compounding throughout its storage and usage.
A stability-indicating method for API potency is an analytical technique designed to accurately determine the concentration or potency of the API in a pharmaceutical formulation while accounting for potential degradation products. This method is crucial for monitoring the stability of the API over time, ensuring that it retains its intended potency throughout its shelf life.
A stability-indicating method for API potency is an analytical technique designed to accurately determine the concentration or potency of the API in a pharmaceutical formulation while accounting for potential degradation products. This method is crucial for monitoring the stability of the API over time, ensuring that it retains its intended potency throughout its shelf life.
What tests are required and recommended?
- Required
- Potency assay
- Appearance
- Subvisible particulates
- Antimicrobial Effectiveness Testing (Only final timepoint is required)
- Container Closure Integrity
- Recommended
- pH, if applicable
- Sterility (CCIT in lieu of sterility)
The two Phases of a Stability Study
- Phase 1 consists of Stability Indicating Method and any validations and method suitability.
- Phase 2 consists of the specified test carried out over the timepoints.
Example Phase 2 Timepoints
| Test | T0 | T30 | T60 | T90 |
|---|---|---|---|---|
| Potency | ✔ | ✔ | ✔ | ✔ |
| pH | ✔ | ✔ | ✔ | ✔ |
| Appearance | ✔ | ✔ | ✔ | ✔ |
| Particulate <788> | ✔ | ✔ | ✔ | ✔ |
| CCIT | ✔ | ✔ | ✔ | ✔ |
| AET | ✔ | ✔ | ||
| Sterility | ✔ | |||
| Endotoxin | ✔ |
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