Outsourced Testing
Stability Testing
ICH-Compliant Shelf Life Studies
Stability testing evaluates how a product performs over time when exposed to environmental conditions such as temperature, humidity, and light. These studies help determine shelf life, storage requirements, packaging suitability, and overall product quality throughout its lifecycle. Stability testing is a critical component of product development and regulatory compliance for pharmaceutical, cosmetic, personal care, healthcare, and consumer products.
Our Stability Testing Capabilities
- Accelerated Stability Testing
Evaluate product performance under elevated temperature and humidity conditions to predict long-term stability.
- Real-Time Stability Studies
Monitor products under normal storage conditions throughout their intended shelf life.
- Photostability Testing
Assess product sensitivity to light exposure and packaging effectiveness.
- Freeze-Thaw Studies
Determine product robustness during shipping and storage fluctuations.
- Customized Stability Programs
Tailored study designs based on product type, formulation, packaging, and market requirements.
Outsourced Testing Services
Why Stability Testing Matters
- Establish product shelf life
- Support expiration dating claims
- Evaluate packaging performance
- Verify product integrity over time
- Meet FDA and ICH expectations
- Reduce risk of product failures
- Support commercialization and market expansion
Industries We Support
Pharmaceutical Products- ICH-compliant stability studies supporting drug development and commercialization.
Cosmetics & Personal Care- Evaluate color, odor, viscosity, pH, microbial performance, and product appearance over time.
Healthcare Products- Support OTC products, medical products, and consumer health formulations.
Consumer Products- Assess stability and shelf-life performance under expected market conditions.
Stability Testing & Environmental Storage Conditions
In stability studies, products are packaged in suitable containers and stored under a variety of environmental conditions. Most commonly, the products are stored under exaggerated (also known as “accelerated”) and normal (or “long term”) conditions. Under accelerated conditions, the product is subjected to elevated levels of temperature and humidity. Under long term conditions, the product is stored in an environment that is designed to mimic that of a normal room atmosphere.
Galbraith Laboratories offers a variety of storage conditions in their Cincinnati, OH and Knoxville, TN locations:
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Most commonly requested conditions include: 25°C ± 2°C / 60% RH ± 5% RH |
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40°C ± 2°C / 75% RH ± 5% RH |
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We also have more custom conditions, with the ability to adapt conditions to client specifications: |
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5°C ± 2°C / 20% RH ± 5% RH 37°C ± 2°C / 60% RH ± 5% RH 45°C ± 2°C / 75% RH ± 5% RH 50°C ± 2°C / 75% RH ± 5% RH |
At pre-defined time intervals, samples of the product are removed from storage and tested for characteristics such as preservative efficacy, purity, degradation products, and observed for physical changes. These types of studies enable product manufacturers to select the optimum formulation, packaging containers, recommended storage conditions, and expiration dates for final packaged products.
The temperature/humidity chambers are monitored 24/7 with alerts and emergency backup generators to ensure continuous power during electrical events and maintain compliance with FDA 21 CFR 11.
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FAQ
How long does stability testing take?
Stability testing timelines depend on the study design. Accelerated studies may take several months, while real-time studies typically run for the intended shelf-life period.
What are ICH stability testing guidelines?
ICH guidelines provide internationally recognized standards for stability studies, helping manufacturers establish shelf life, storage conditions, and product quality requirements.
What is accelerated stability testing?
Accelerated stability testing exposes products to elevated temperature and humidity conditions to predict long-term product performance and shelf life.
Why is stability testing important?
Stability testing helps ensure products remain safe, effective, and compliant throughout their intended shelf life.
What products require stability testing?
Pharmaceuticals, cosmetics, personal care products, healthcare products, and many consumer products benefit from stability testing programs.