STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS Q1A(R2)
Stability testing provides data on how the quality of a pharmaceutical product varies over time and under the influence of various environmental factors (such as temperature and humidity). This allows for the determination of storage conditions and the establishment of the product's shelf life.
Stability studies should be conducted on all intended dimensions and types of packaging for the product's market release.
These studies are performed in climatic chambers, under controlled humidity and in conditions defined according to the ICH guidelines.
Long-term conditions are used to establish the expiration date of the product.
Accelerated degradation is a study designed to increase the rate of chemical degradation or physical alteration of an active substance while remaining compatible with the mechanisms involved in normal storage.
Storage Conditions:
- Long-term: 25°C / 60% RH
- Intermediate: 30°C / 65% RH
- Accelerated: 40°C / 75% RH
When degradation is observed under accelerated conditions, it is recommended to switch to intermediate conditions.
Sampling Frequency:
- Long-term: T0, T3, T6, T9, T12, T18, T24, and T36 months
- Intermediate: T0, T3, T6, T9, and T12 months
- Accelerated: T0, T3, and T6 months