Insight into stability, safety and shelf life
Temperature, humidity, light and storage conditions can all have a direct impact on product quality, efficacy and shelf life. That is why stability studies are an essential part of drug development, quality control and market authorisation.
Normec supports pharmaceutical and life sciences organisations with stability studies and controlled sample storage under strictly monitored conditions. We combine high-quality laboratory testing with reliable storage facilities that comply with GMP and ICH guidelines.
Stability studies in accordance with GMP and ICH guidelines
Every stability study requires a carefully structured approach. Each project starts with a detailed protocol defining the samples, test conditions, analytical methods and sampling intervals.
Our services include:
- Initial stability studies for new products
- Ongoing stability studies for commercial products
- In-use stability studies
- Photostability studies for light-sensitive products
- Sample storage under ICH conditions
All studies are performed in accordance with current GMP and ICH guidelines, supporting organisations throughout regulatory submissions, clinical studies, quality control and product launch.
Controlled storage under strictly monitored conditions
Reliable stability studies begin with stable storage conditions. Normec operates qualified storage chambers with continuous monitoring of temperature and humidity.
We support standard ICH storage conditions, including:
- –20°C ± 5°C
- 5°C ± 3°C
- 25°C ± 2°C / 60% relative humidity ± 5%
- 30°C ± 2°C / 65% relative humidity ± 5%
- 30°C ± 2°C / 75% relative humidity ± 5%
- 40°C ± 2°C / 75% relative humidity ± 5%
All storage units are monitored 24 hours a day, 7 days a week. If any parameter falls outside specification, an alarm system is activated immediately to protect sample integrity. We also provide customised storage conditions and tailored storage solutions where required.
Analytical expertise for reliable results
Accurate analytical testing is essential to detect trends, degradation or deviations at an early stage during stability studies.
Our specialists have extensive expertise in:
- Physical testing
- Chemical analysis
- Microbiological testing
- Analysis of active pharmaceutical ingredients (APIs)
- Analysis of excipients and finished products
We routinely work with pharmacopoeial methods in accordance with BP, EP, JP and USP, as well as CEP methods and customer-specific analytical methods. Using modern instrumentation, validated processes and statistical data evaluation, we deliver reliable, regulatory-compliant results.
Supporting safe pharmaceutical products
Normec provides flexible support tailored to your manufacturing, quality and development processes. With fast turnaround times, customised study protocols and practical guidance, we help organisations work efficiently while maintaining compliance.
Together, we help you develop safe, stable and reliable pharmaceutical products with confidence.
Would you like to know more about stability studies and sample storage?
Frequently Asked Questions
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Stability studies evaluate how pharmaceutical products respond to factors such as temperature, humidity, light and storage conditions.
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They provide insight into a product's shelf life, safety, efficacy and quality throughout storage and use.
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ICH conditions are internationally recognised storage conditions used for pharmaceutical stability studies.
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An in-use stability study evaluates how stable a product remains after it has been opened or is in use.
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A photostability study determines how sensitive a product is to exposure to light.
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Yes. We offer controlled sample storage under a range of temperature and humidity conditions.
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We perform physical, chemical and microbiological analyses for active pharmaceutical ingredients, excipients and finished products.