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ICH Stability Testing Services

Offering stability storage for all key ICH climatic zones. Our available conditions and storage solutions are suitable for long term, intermediate, accelerated, photo-stability, in-use and FUST stability trials.

Stability testing is a key component of the chemical, manufacturing and control (CMC) section of the Common Technical Document. Its purpose is to provide data and information as to how the quality of active pharmaceutical ingredients (API), investigational medicinal products (IMP) and finished pharmaceutical products are maintained with the passage of time. Continuity of the originally manufactured quality is key to assuring both patient safety and determining the shelf life of the aforementioned types of pharmaceutical preparation.

The ICH guidelines provides recommendations on stability testing protocols specifically temperature, humidity and duration for climatic Zone I and II, III and IV in order to minimise the different storage conditions for submission of a global dossier. At Tepnel we have developed over 25 years of stability testing experience across the full range of formulation types for both large and small molecules.

ICH stability zones

Zone Type of Climate
I Temperate
II Mediterranean/subtropical
III Hot dry
IV Hot humid/tropical
IVb ASEAN testing conditions hot/high humidity

Long term testing requirements

Zone Temperature Humidity Minimum Durations
I 21ºC ± 2ºC 40% RH ± 5% RH 12 Months
II 25ºC ± 2ºC 60% RH ± 5% RH 12 Months
III 30ºC ± 2ºC 35% RH ± 5% RH 12 Months
IV 30ºC ± 2ºC 65% RH ± 5% RH 12 Months
IVb 30ºC ± 2ºC 75% RH ± 5% RH 12 Months
Refrigerated 5ºC ± 3ºC No humidity 12 Months
Frozen -15ºC ± 5ºC No humidity 12 Months

 

Accelerated and intermediate testing conditions

Zone Temperature Humidity Minimum Durations
Accelerated ambient 40ºC ± 2ºC 70% RH ± 5% RH 6 Months
Accelerated refrigerated 25ºC ± 2ºC 60% RH ± 5% RH 6 Months
Accelerated frozen 5ºC ± 3ºC No humidity 6 Months
Intermediate 30ºC ± 2ºC 65% RH ± 5% RH 6 Months

 

Our GMP compliant facilities in Livingston, Scotland contain stability storage capacity and conditions which are continuously monitored, mapped, annually qualified and validated to ensure ongoing compliance and traceability to national standards. Coupled with an extensive set of analytical testing laboratories including full on site pharmaceutical microbiology support, we specialise in oral dosage units, inhalation formulations and vaccine formulations.

Tepnel is a named Quality Control Analytical Laboratory on multiple product licenses in both the EEA and US.

Our ICH stability testing services include:

 

Sections in cGMP Analytical Services

All cGMP Analytical Services

Additional Resources

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