Stability testing provides evidence of how the quality of an active pharmaceutical ingredient (API), medicinal product or medical device varies over time. This approach also takes into account the influence of a variety of environmental factors, such as temperature, humidity and light.
This approach also takes into account the influence of a variety of environmental factors, such as temperature, humidity and light. Stability testing also evaluates the potential interaction of a medicinal substance with other active ingredients or excipients, as well as contact with the container closure system and packaging materials.
Mérieux NutriSciences performs accelerated, intermediate and long-term stability studies and photostability studies to ensure the regulatory compliance of active ingredients, medicinal products and medical devices.
We offer the following stability conditions for pharmaceutical stability storage:
• 25°C ± 2°C / 60% RH ± 5% RH
• 30°C ± 2°C / 65% RH ± 5% RH
• 30°C ± 2°C / 75% RH ± 5% RH
• 40°C ± 2°C / 75% RH ± 5% RH
All climatic conditions are continuously monitored using BMX eviSENSE LabguardTM software, ensuring a totally secure and controlled environment.
Our most common tests & services
All our Tests and Services
A medical device, or a material used in a medical device, that comes into direct contact with patients must be able to perform its intended function without inducing significant rejection.
Mérieux NutriSciences provides a comprehensive range of microbiological services relating to medical devices, to support facility and product monitoring, as well as product development and registration.
In relation to pharmaceutical products and medical devices derived from raw materials of animal origin, for which the raw material may contain viruses that are dangerous to human health...
Mérieux NutriSciences has a proven track record in carrying out studies of extractables and leachables in order to detect very low levels of contaminants from materials in contact with medicinal products and medical devices.
Mérieux NutriSciences offers method development and validation solutions for every analytical challenge, through the availability of several qualified analytical techniques in specialized GMP labs.
Forced degradation is synonymous with stress testing and plays a key role in the development of stability-indicating and analytical methods, establishing operative conditions and the design of formulations.