Confidence in product stability, quality and shelf life
A pharmaceutical product must remain effective not only at the time of manufacture but throughout storage, transport and use. Compatibility and stability studies provide insight into how pharmaceutical products perform under different conditions, helping to ensure product quality, safety and shelf life.
Normec supports pharmaceutical and biopharmaceutical organisations with GMP-compliant stability studies and controlled storage facilities. Every study is tailored to the product, its stage of development and your organisation's specific quality requirements.
Stability studies in accordance with GMP and ICH guidelines
Reliable stability studies require accurate monitoring, dependable analytical testing and strict control of storage conditions. That is why all our studies are performed in accordance with applicable GMP and ICH guidelines.
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
- Compatibility studies for product and packaging combinations
Each study begins with a tailored protocol that clearly defines storage conditions, analytical methods and testing intervals.
Controlled storage under carefully monitored conditions
Reliable results begin with stable storage conditions. Our qualified storage chambers provide continuous monitoring of temperature and humidity to ensure sample integrity throughout the study.
Our storage facilities support standard ICH conditions, including:
- –20°C ± 5°C
- 5°C ± 3°C
- 25°C ± 2°C / 60% RH ± 5%
- 30°C ± 2°C / 65% RH ± 5%
- 30°C ± 2°C / 75% RH ± 5%
- 40°C ± 2°C / 75% RH ± 5%
All storage units are monitored 24/7. If any parameter moves outside its specified range, an automated alarm system is immediately activated to protect sample integrity.
Analytical expertise for reliable stability data
Our specialists have extensive experience in physical, chemical and microbiological testing of active pharmaceutical ingredients (APIs), excipients and finished products.
We perform analyses in accordance with:
- BP, EP, JP and USP methods
- CEP methods
- Transferred analytical methods
- Client-specific analytical methods
Using modern analytical equipment and statistical evaluation of test results, we identify trends and detect potential degradation at an early stage. This enables organisations to make well-informed decisions throughout product development, regulatory submissions and quality control.
Support throughout every stage
From clinical development to commercialisation and ongoing quality assurance, reliable stability data provide the foundation for regulatory compliance and product safety.
Normec supports organisations with flexible laboratory services, rapid turnaround times and practical guidance throughout complex projects. Our services integrate seamlessly with your existing manufacturing, quality and supply chain processes.
Would you like to know more about compatibility and stability studies?
Frequently Asked Questions
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These studies evaluate how pharmaceutical products respond to environmental factors such as temperature, humidity, light and storage conditions.
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Stability studies demonstrate the shelf life, safety and efficacy of pharmaceutical products throughout storage and use.
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We perform stability studies in accordance with GMP and ICH guidelines.
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In-use stability studies evaluate how stable a product remains after it has been opened or prepared for use.
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A photostability study assesses how exposure to light affects the stability of a pharmaceutical product.
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We offer controlled storage under a range of standard ICH temperature and humidity conditions.
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Yes. We design tailored study protocols and storage conditions based on your product and project requirements.