Here both are the different
testing only 40°C/75 RH
Study here time period are 1,3,6,12
Each batch perform Accelerated stability study
Here we have to seen that naturally degraded drug product which is covered According to WHO guidelines
storage condition of climatic zone IVa and zone IVb? Zone IV a: 30°C and 65% RH (hot and humid countries) Zone IV b: 30°C and 75% RH (hot and very humid countries Countries(e.g., 50°C, 60°C) comes under climatic zone IVb? Brazil, Cuba, China, Brunei, Cambodia, Indonesia, Malaysia, Myanmar, Philippines.
oxidation, and photolysis, hydrolysis, alklalation, high humidity, temperature etc test perform,
Required only one batch during DMF file submition.
Purpose force degradation
identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used.