ICH Stability Testing and Storage
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 over 25 years of stability testing experience across the full range of formulation types for both large and small molecules.
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 licences in both the EEA and US.
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 ICH stability
testing services include:
- Storage conditions: 25°C/60% RH, 30°C/65% RH, 40°C/75% RH, 3-8ºC and -20ºC.
- Other non-standard temperatures and relative humidity’s on request
- Stability testing and analysis (HPLC, LC/MS, GC)
- Forced degradation studies including; photo stability, oxidation, thermal stability
- Sterility / viable microbiological assessment
- Package integrity
- Endotoxin levels (LAL)
- Bioburden
Accelerated stability assessment programmes for excipient compatibility trials
For Accelerated Development of pharmaceuticals time is of the essence. Particularly for oncology development where time to market means saving lives. For oncology development stacked activities and compressed time lines means getting it right the first time. Picking winners by screening your API options, future proofing your analytical methods to develop a method that works for both API and formulation. Then degradation testing of the API in the presence of different excipients are all essential parts of accelerated development. After an in-silico assessment by computer simulation the degradation routes of the API are challenged under accelerated conditions.
- A tool to provide information for the accelerated development of pharmaceuticals.
- Based on the Arrhenius equation (every 10oC increase doubles the rate of a chemical reaction).
- Allows for accelerated testing to be performed at multiple temperatures and humidity’s (10 – 80oC/0 – 95%RH).
- Temperatures and humidity’s are selected by the software to maximise stress without changing physical form.
- Rapid screening of APIs and excipients.
- The effect of temperature and humidity can be modelled and quantified
- Stability performance can be predicted for any package type and climatic zone.
- In-use stability and the effects of temperature and humidity excursions can be assessed.
- Provides a rapid way to compare different formulations reducing the testing time to select the best formulation to take forward.
