Stability Storage & Analysis
About this service
Stability analysis is critical in assessing the integrity and quality of pharmaceutical products over time. Stability studies are an essential component of the drug development process, providing valuable data to support product shelf-life determinations and regulatory submissions.
We conduct comprehensive stability studies following international guidelines, including ICH (International Council for Harmonisation) and regional regulatory requirements. We design these studies to assess the effects of various environmental conditions on products, such as temperature, humidity, and light.
Real-Time Stability Studies
Real-time stability studies involve subjecting samples of pharmaceutical products to specific storage conditions representative of long-term storage. These studies provide valuable data on how the product degrades over time, allowing us to estimate its shelf life and recommended storage conditions accurately.
Accelerated Stability Studies
Accelerated stability studies involve subjecting samples to elevated temperature and humidity conditions for a shorter duration to simulate the long-term stability of the product. By accelerating the degradation process, we can quickly assess the product’s stability under stressed conditions and obtain valuable insights into its potential degradation pathways.
Forced Degradation Studies
In forced degradation studies, we intentionally subject the product to harsh conditions, such as heat, humidity, light, and oxidative stress, to accelerate degradation and determine potential degradation pathways. These studies help identify and characterize degradation products and impurities, which are essential for assessing product stability and ensuring its safety. We also use use ASAPrime™ software to quickly and accurately determine product shelf-life.
Interpreting and Analysing Data
Our team meticulously analyses stability study data to determine the degradation kinetics and establish the product’s stability profile. By understanding the rate of degradation and identifying critical degradation products, we can develop appropriate storage conditions and packaging recommendations to maintain product quality.
Stability Data Reporting
We provide comprehensive stability data reporting, including graphical representations and statistical analyses so clients can make informed decisions regarding product shelf life, storage conditions, and regulatory submissions.
Ongoing Stability Monitoring
Even after product commercialisation, stability monitoring remains a crucial aspect of ensuring product quality throughout its lifecycle. Our team can assist with ongoing stability monitoring to assess product quality over an extended period and make any necessary adjustments to storage conditions or formulations.
Stability Storage at Custom
All stability storage units at Custom are remotely monitored 24 hours a day for temperature and humidity with on call engineers available.
