Stability Storage And Testing
The drug is kept in environmentally controlled chambers and its under these conditions, that the trial batches are exposed to a stimulated environment and the batches are tested upon various parameters, in order to define the shelf life.
BioLink Lifesciences provides Stability Storage services wherein samples are placed inside environmentally controlled chambers that also helps in stimulated testing of the drug samples under all 5 climatic zones and recommended testing conditions, as defined by the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human use).
Our stability storage services fully conform with the ICH and non-ICH requirements and it also reports data on changes recorded in the physical, chemical, biopharmaceutical and microbiological properties when the drugs are stored in a perfectly stimulated chamber.
Stability Studies generate critical data that is assessed during registration and commercialization of the drug product. These studies also reveal the efficiency and integrity of the drug while it is stored and it even provides accurate data on the safety and effectiveness of the drug, when it’s supplied to different parts of the world.
Well framed and documented quality stability data for supporting various phases of drug development is our forte and passion.
We perform Stability Testing that determines the alterations observed in the drug substances. These alterations may come up due to the change in environmental factors. And yes, we offer both kinds of Stability Testing:
Real-time Stability Testing
Accelerated Stability Testing
Stability Testing reveals verified & evidence-based data and information on the changes that impact the storage and shelf life of drugs, APIs with the passage of time.