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|
|IVb||ASEAN testing conditions hot/high humidity|
Long term testing requirements
|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
|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:
- 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)