Do you require Stability Testing services, also known as Shelf-life Studies, for the registration of a new Drug Substance (Active Pharmaceutical Ingredient, API) or Drug Product (Finished Dosage Form, FDF)?
Stability Testing services provide essential data on how the quality of an API or FDF varies over time under the influence of temperature and humidity. This enables the establishment of recommended storage conditions, re-testing intervals and shelf-lives.
Eurofins BioPharma Product Testing Netherlands (“EBPT-NL”) can be your complete outsourcing partner to register your product for various international markets. Our WHO-prequalified and EU-GMP accredited laboratories in the Netherlands, are fully equipped for stability testing in line with ICH conditions (listed below).
ICH Stability Testing services comprise Regular (Pivotal as well as Commercial batches) and On-Going; In-Use; Freeze-Thaw; and Forced Degradation and Photostability Studies and are described in more detail below.
EBPT-NL houses walk-in rooms for the most common climate zones, i.e. long-term (25H60), intermediate (30H65) and accelerated (40H75). For other ICH conditions climate cabinets are available. All rooms and cabinets are continuously monitored by automated monitoring systems with full back-up of data and power supply. The available conditions are listed hereunder.
- ≤ - 60 °C (Deep Frozen)
- - 20 ± 3 °C (Frozen)
- 5 ± 3 °C (Refrigerated, Accelerated Frozen)
- 15 ± 3 °C
- 25 ± 2 °C / 40 ± 5 % RH
- 25 ± 2 °C / 60 ± 5 % RH (ICH Zone II, Accelerated Refrigerated)
- 30 ± 2 °C / 65 ± 5 % RH (ICH Zone IVa, Intermediate)
- 30 ± 2 °C / 70 ± 5 % RH
- 30 ± 2 °C / 75 ± 5 % RH (ICH Zone IVb)
- 40 ± 2 °C / 75 ± 5 % RH (Accelerated Ambient)
Regular and On-Going Stability
Regular stability studies do not need more elaboration than stating that EBPT-NL executes those on pivotal (clinical trial medication) and commercial batches. On-Going studies are executed on commercial batches only, namely one batch per annum per product.
In-Use stability studies are typically executed on multi-dose products such as topical (gels, creams, lotions, etc.), eye and ear drops and oral liquids. An In-Use study is mostly run in parallel with a Regular stability study, i.e. at one or multiple time points of the Regular study an In-Use study starts whereby the time point of the Regular study (e.g. 6 months) serves as the initial time point for the In-Use study. The In-Use study typically lasts several days or weeks.
During transportation of a product it is not uncommon that it is subjected to extreme temperature conditions such as freezing or overheating. For some products it is necessary to be able to withstand a certain degree of temperature change during transport.
Freeze-Thaw studies put products through a series of extreme temperature changes, the so-called freeze-thaw cycles. An example of a freeze-thaw cycle is exposing the product to freezing temperatures (approximately -15°C to -25°C) for 24 hours and then store it at a higher temperature (approximately 25°C) for 24 hours. The sample is then analyzed for significant changes. This completes one cycle. If no significant changes are observed after three cycles one can be confident that the product is sufficiently stable for transport.
Forced Degradation and Photostability
Forced degradation studies, also known as stress testing, play a central role in formulation development, manufacturability assessment and development of stability-indicating analytical test methods. A stability-indicating method is a method that accurately and precisely measures a drug substance or drug product well separated from process impurities, excipients and degradation products. Stress tests generate representative samples to assess drug substance and drug product stability, provide information about possible degradation pathways and demonstrate the stability-indicating power of the analytical procedures applied.
The execution of a Forced Degradation Study routinely includes treatment of samples with acid, base, peroxide, temperature and light. Other conditions can be added upon request or after evaluation of the first results.
For the application of light a specific cabinet is used that imitates sunlight and adheres to ICH Guideline Q1B. This cabinet and guideline are also in Photostability Studies, i.e. studies to assess the light sensitivity of API’s or FDF’s.
If you require advice on your stability program, the various types of stability studies or more information on our stability storage capacity then please contact us.