Stability & Shelf Life Testing

Stability tests are designed to test and provide evidences regarding the variation in product quality over time and in face of the influence of a variety of environmental factors, such as: temperature, humidity and light, in addition to other factors related to the product itself, such as physical properties and chemicals.

The stability tests provide indications about the behavior of the product, in a certain period of time, in view of the environmental conditions to which it may be subjected, from the manufacture to the end of its validity.

Specific tests include:

• ICH Q1A Accelerated Testing (40°C, 75% RH)
• ICH Q1A Intermediate Testing (30°C, 60% and 65% RH)
• ICH Q1A Long-term Testing (25°C, 65% RH or 30°C, 65% RH)
• ICH Q1A Refrigerated Product Testing (5°C or 25°C, 60% RH)
• ICH Q1B & VICH GL5 Photostability testing
• ASEAN/WHO stability testing (30°C, 75%RH, or 40°C, 75%RH)

5 Types of Stability for Products

Stability testing is an essential part of the drug development process, which involves evaluating the chemical and physical properties of a drug product to ensure its safety and efficacy. During stability testing, several types of stability are generally recognized.

1. Chemical stability: This refers to the ability of a drug product to maintain its chemical integrity and purity over time. Chemical stability is usually assessed by monitoring the degradation of the active pharmaceutical ingredient (API) and the formation of degradation products.
2. Physical stability: This refers to the ability of a drug product to maintain its physical properties over time, such as its appearance, particle size and viscosity. Physical stability is usually assessed by monitoring changes in the appearance and physical properties of the drug product.
3. Microbiological stability: This refers to the ability of a drug product to maintain its microbiological purity over time. Microbiological stability is usually assessed by monitoring the growth of microorganisms in the drug product.
4. Packaging stability: This refers to the ability of a drug product to maintain its stability when stored in the packaging material used for its distribution. Packaging stability is usually assessed by monitoring changes in the drug product's stability under different packaging conditions.
5. Storage stability: This refers to the ability of a drug product to maintain its stability under different storage conditions, such as temperature, humidity and light exposure. Storage stability is usually assessed by monitoring changes in the drug product's stability over time under different storage conditions.