STABILITY STUDIES
Every beginning has an end. We’ll tell you when.
Our facilities are equipped with climatic chambers that meet the requirements of ICH guidelines, as well as the environmental conditions required by the Stability Studies of the Authorities in the various countries or climatic zones where the product will be marketed. In these chambers, we record the product’s evolution under the influence of different environmental factors such as temperature, humidity, and light. These studies allow us to determine the product’s expiry date or shelf life. In addition, thanks to our extensive expertise in formulation and analytical determinations, you will always have the best alternatives and possible courses of action available should the results fall outside specifications.
STUDIES AND SERVICES
+ Preliminary stability studies
+ Stability studies according to ICH Q1A guideline
+ On-going stability studies
+ Forced degradation studies
+ Photostability studies according to ICH Q1B guideline
+ Compatibility studies
+ Sample storage service under controlled conditions
STORAGE CONDITIONS
+ Long-term Zone II (25°C / 60% RH)
+ Long-term Zone IVb (30°C / 75% RH)
+ Intermediate conditions (30°C / 65% RH)
+ Accelerated conditions (40°C / 75% RH)
+ 2 – 8 ºC
+ Possibility of assessing specific conditions
CONTROL PARAMETERS
+ Organoleptic properties
+ Physicochemical properties
+ Chemical properties
+ Microbiological control