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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.
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
Our comprehensive service starts with study plan and protocols, conducting the studies and writing the report. In addition, we provide data analysis to calculate product shelf-life based on real-time data.
