ICH Stability Storage and Testing
Stability testing is performed to determine how a drug substance (active pharmaceutical ingredient or finished product) is altered over a given period of time, under the influence of various environmental factors, such as humidity, temperature, light, and typical storage conditions. The results determine the product’s shelf life, as well as optimal storage and shipment conditions.
Avoid drug development delays and accelerate FDA approval by partnering with Altasciences, a CDMO that can overcome any analytical hurdles that may arise during this critical milestone.
Equipped with state-of-the-art analytical laboratories and on-site, ICH-compliant stability chambers that meet all cGMP requirements, Altasciences’ laboratory is ready to handle all your needs and help gain regulatory approval for your product. Our experts provide a wide range of analytical testing services, including method development and validation, ICH stability testing and storage (in real-time and long-term), pharmaceutical product degradation testing, and much more.
Our facility offers standard ICH conditions, as well as custom storage conditions, to ensure the most stable and uniform environments for your materials. Altasciences’ environmental chambers are continuously monitored by Rees Scientific, a centralized monitoring system that provides our team with 24/7/365 data and real-time alerts to ensure your products or samples remain within the desired specifications.
Our cGMP stability testing and storage services include:
- cGMP registration stability programs
- Protocol design and program management
- Development and validation of stability-indicating methods
- Stability testing of APIs, finished pharmaceutical products, clinical trial materials, and formulated products
- Tailored reporting (timepoint and final reports)
- Temperature cycling, freeze-thaw study, and shipping studies
- Forced degradation testing
- Real-time stability testing
- Long-term stability testing
- Intermediate stability testing
- Accelerated stability testing
- In-use stability testing
- Follow-up stability trials
- Formulation stability testing
All of Altasciences’ stability chambers are on our backup generator and include the following conditions:
- -80 °C
- -20 °C
- 5 °C (walk-in chamber)
- 25 °C/60% relative humidity (RH), walk-in chamber
- 30 °C/65% RH
- 30 °C/75% RH
- 40 °C/75% RH
Request a full virtual tour of our manufacturing and analytical facility.
Do you need stability testing and storage for your product? Send us a message.