Early and robust stability testing helps assess the developability of an API drug substance or drug product formulation, while less intensive stability testing serves as a reference point for the ongoing development program. Our stability testing services inform your drug product’s shelf life, suggest appropriate storage conditions before and after opening, and identify potential degradation or quality concerns. These insights also help select packaging and closure systems and support the development of stability-indicating analytical methods.
Our team is adaptable to your needs and conducts formal ICH stability studies following provided methods, compendial methods, or methods developed and validated by us. We use a formal stability tracking system that fully complies with regulatory processes for optimal compliance. With our support, your program can conduct accelerated, intermediate, long-term, and in-use stability studies to meet your needs.
STABILITY STORAGE CONDITIONS
Identify the appropriate storage conditions for your product by testing against our variety of parameters. No matter the needs and conditions of your project, we have the space to execute.
-80°C, Reach-In
-20°C, Reach-In
5°C, Walk-In
25°C/60% RH, Walk-In
30°C/65% RH, Walk-In
30°C/75% RH
30°C/70% RH
40°C/75% RH, Walk-In
40°C/10% RH
50°C/10% RH
37°C, 45°C and 50°C Accelerated Aging
Custom Conditions and Reach-In Chambers
Photo-Stability, ICH Q1b (Option 2)
Continuous Monitoring and Emergency Power Systems
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