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, 湿度和光. It is important to understand all the 监管 requirements, 例如ICH指南, which establish guidance for stability storage and testing programs for new drug substances and drug products.
网赌最正规的平台和 Q1科学的 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. +, 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℃±2℃/ 60%rh±5%rh
- 25℃±2℃/ 40%rh±5%rh
- 30℃±2℃/ 65%rh±5%rh
- 40℃±2℃/ 75%rh±5%rh
- 40℃±2℃/ 25%rh±5%rh
- 60°C ± 2°C
- 5°C ± 3°C
- -20°C ± 5°C
- -70°C ± 15°C
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). 除了传统的保质期稳定性研究, 网赌最正规的平台定期进行专门的研究, 如冻结/解冻温度循环, 相容性和光稳定性研究.
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.