Stability studies – Real time and accelerated |
We can help you review your existing stabilities or help you design new ones by assisting you with preparation Stability testing Protocols in compliance with ICH guidelines. Studies can be real time or accelerated as the requirement may be and can be suited to specific dosage forms. Correct conditions in terms of temperature and humidity have to be ascertained. Selection of tests, analysis, reporting of data and validation of facilities and procedures have also to be taken care of. By intensively reviewing the results and data from stability studies, we can prepare comprehensive stability test reports and together with your technical people, taking into consideration regulatory guidelines, decide on the shelf life for your drug substance or finished formulation. Studies can be conducted at the client’s site by providing them the technology to set up the adequate facilities or at our facility. |
