Stability testing demonstrates how drug product and drug substance attributes change over time and how they are affected by environmental factors such as temperature, humidity, and light. Such changes may occur during storage and influence quality, safety, and efficacy.
The tests primarily cover physical and chemical changes and microbial growth. With a dedicated stability room, our team will provide you with customized support and program management for all aspects of stability, from stability method development and validation to clinical stability and release testing.
Evaluate your products under these ICH-qualified storage conditions:
- 5 ± 3 °C
- 25 ± 2 °C, 60 ± 5% RH
- 30 ± 2 °C, 65 ± 5% RH
- 40 ± 2 °C, 75 ± 5% RH