Stability Storage

Stability storage and testing is a critical component of the drug development lifecycle. It is necessary to demonstrate how the quality of drug substances and drug products vary over time when exposed to environmental factors such as temperature, humidity and light. It is important to understand all the regulatory requirements, such as the ICH Guidelines, which establish guidance for stability storage and testing programs for new drug substances and drug products.

Cambrex and Q1 Scientific’s stability storage and sample management capabilities provide a variety of pharmaceutical storage conditions, with walk-in and reach-in chambers that meet all ICH Q1A requirements. Plus, our experts have extensive experience conducting stability studies across the entire life cycle of a product, from early development of the API to process validation of the drug product.

We provide the following standard ICH stability storage conditions:

• 25°C ± 2°C / 60%RH ± 5%RH
• 25°C ± 2°C / 40%RH ± 5%RH
• 30°C ± 2°C / 65%RH ± 5%RH
• 40°C ± 2°C / 75%RH ± 5%RH
• 40°C ± 2°C / 25%RH ± 5%RH
• 60°C ± 2°C
• 5°C ± 3°C
• -20°C ± 5°C
• -70°C ± 15°C
• Custom conditions/validation also available

Our chambers are mapped and fully qualified for long-term and short-term shelf-life studies that include intermediate and accelerated testing per ICH Q1A (R2). In addition to traditional shelf-life stability studies, Cambrex routinely performs specialized studies, such as freeze/thaw temperature cycling, compatibility and photostability studies.

Our analytical experts can support your stability storage and testing at all phases of development, and we offer a seamless experience from sample receipt to report issuance.