ICH Stability Studies
We are equipped to conduct comprehensive stability studies as per ICH Guidance Q1A (R2). Our team monitors your products under a range of environmental conditions to ensure they maintain their quality and efficacy over time.
What do we test?
We provide stability studies for:
New Drug Substances and Products
Reformulated or Repackaged Products
Accelerated and Long-Term Stability Testing
What storage conditions do we offer?
Our stability chambers are validated and monitored to provide precise conditions, including:
- Accelerated Testing: 40°C ± 2°C / 75% RH ± 5% RH
- Intermediate Testing: 30°C ± 2°C / 65% RH ± 5% RH
- Long-Term Testing: 25°C ± 2°C / 60% RH ± 5% RH
What guidelines do we follow?
All studies are conducted in compliance with ICH guidelines and tailored to meet specific regulatory requirements for your product.
How should I send my samples?
Ensure samples are packaged securely and include detailed documentation regarding product specifications and intended storage conditions.