Pharmaceutical Stability Testing (ICH) & Storage

ILS Limited Pharmaceutical Stability TestingILS provide pharmaceutical stability testing and accelerated stability testing and stability storage from pre-clinical enabling stability on API's through to phase III and phase IV clinical trials.

Our brand new, state of the art pharmaceutical chemistry laboratories offer a full range of monitored temperature and humidity stability storage and laboratory testing conditions.

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.

ILS stability storage covers the requirements of the ICH Guidelines.

ILS ICH Conditions

The standard ICH temperatures are:

25°C / 60%RH - Real time storage condition
30°C / 65%RH - Intermediate storage condition
40°C / 75%RH - Accelerated storage condition


In addition to the standard temperatures, we also routinely offer

30°C / 75%RH
25°C / 40%RH
5°C 

We have additional stand alone chambers that can be set up to other temperatures and humidities.

 

Impurities in New Drug Products

Degradation of samples stored under relevant stress conditions: light, heat, humidity, acid/base hydrolysis, and oxidation in accordance with ICH Q3B.

 

We pride ourselves on customer service and value all of our customers please contact us to see if we can help you with your stability testing requirements.

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