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Our stability tests are ICH compliant, adhering to the guidelines and best practices recommended by the International Conference on Harmonization (ICH). Agno uses advanced digital systems to monitor our test chambers 24 hours a day, helping to ensure that temperature and humidity conditions are under control. We store samples under exactly defined conditions that are continuously documented. We have in-house stability chambers meeting ICH Q1A (Zones I & II) and ICH Q1F (Zones III & IV) requirements. The required temperature and humidity are monitored continuously and the ICH photostability conditions are qualified using NISH traceable photo-meters. The chambers are connected to backup power in case of power failure.
Storage Stability Conditions:
5 ºC ± 3 ºC
25 ºC ± 2 ºC / 60%RH ± 5%RH
30 ºC ± 2 ºC / 65%RH ± 5%RH
40 ºC ± 2 ºC / 75%RH ± 5%RH
ICH Photostability
Stability testing affords essential data on how the quality of a pharmaceutical varies over time under the influence of different environmental factors such as humidity, temperature, and photostability. Our comprehensive service starts with a study plan and a detailed protocol. A detailed report is executed after completion of the studies. In addition, we provide data analysis to calculate product shelf-life based on real-time data.
