Stability study

The expiration dates and storage precautions indicated on the packaging of pharmaceutical products are defined at the end of stability and shelf-life studies. These studies are conducted according to harmonised guidelines that apply to pharmaceutical products worldwide. These are the ICH (International Conference of Harmonisation) recommendations.
The objective of this study is to ensure consistent quality of the product in terms of storage conditions (at various temperatures and moisture levels) and over time (before and after opening)
The AR2i laboratory stores and monitors samples for pharmaceutical and parapharmaceutical laboratories and analyses them over various time frames in compliance with ICH standards.

We have climate chambers equipped with monitoring systems for the following conditions:

Temperature Relative humidity (RH)
Normal conditions: 25°C(± 2°C) 60% rh (±5%)
Intermediate conditions: 30°C(± 2°C) 65% rh (±5%)
Accelerated conditions: 40°C(± 2°C) 75% rh (±5%)
Conditions for semi-permeable packaging: 30°C(± 2°C) 65% rh (±5%)

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Please contact us before sending your samples in order to confirm the feasibility of your analysis by our laboratory, define a time frame and determine the number of samples required.

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