9 Questions
What should be evaluated for aqueous-based products packaged in semi-permeable containers?
Water loss in addition to physical, chemical, biological, and microbiological stability
Under which condition should aqueous-based drug products be demonstrated to withstand?
Low relative humidity environments
What is the minimum time period covered by data at submission for long-term stability testing?
12 months
What is the minimum time period covered by data at submission for accelerated stability testing?
6 months
If the long-term condition is 25°C ± 2°C/40% RH ± 5% RH, what is the intermediate condition?
30°C ± 2°C/35% RH ± 5% RH
What approach can be developed and reported for non-aqueous, solvent-based products?
Comparable approaches can be developed
What does the applicant decide regarding long-term stability studies for drug products?
The specific temperature for storage
"If 30°C ± 2°C/35% RH ± 5% RH is the long-term condition, what happens to the intermediate condition?"
"There is no need for an intermediate condition"
What type of containers should be used when testing drug products for stability under low relative humidity conditions?
Semi-permeable containers
Test your knowledge on pharmaceutical bracketing concepts and climatic zones related to stability testing. Learn about how bracketing can be applied to similar strengths in drug products and the significance of climatic zones in stability testing.
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