Stability testing is necessary to ensure the product is of acceptable quality throughout its entire storage period. In order to do this, it is necessary to monitor compliance of the product with a suitable quality specification throughout the shelf life. It is not acceptable to only test at the time of expiry, for example, on a retention sample (even though the results of this type of testing may provide useful information about the overall stability of the product).
We at THS carry out the stability studies as per the ICH guidelines and provide the following services to support stability testing :Study design, in cooperation with the client Protocol development for client approval Storage of stability samples (alternatively, storage may be performed by the client and ASI may receive samples for testing) Testing of stability samples Interim stability reports, provided after each testing interval A final stability report after the last testing interval QA review of reports and data.
We provide stability study in the form of accelerated and prolonged as well as as per the need of the customers