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Questions and Answers
What should be evaluated for aqueous-based products packaged in semi-permeable containers?
What should be evaluated for aqueous-based products packaged in semi-permeable containers?
- Only physical stability
- Water loss in addition to physical, chemical, biological, and microbiological stability (correct)
- Only microbiological stability
- Only chemical stability
Under which condition should aqueous-based drug products be demonstrated to withstand?
Under which condition should aqueous-based drug products be demonstrated to withstand?
- Extreme temperature conditions
- High relative humidity environments
- Variable light exposure
- Low relative humidity environments (correct)
What is the minimum time period covered by data at submission for long-term stability testing?
What is the minimum time period covered by data at submission for long-term stability testing?
- 6 months
- 12 months (correct)
- 3 months
- 9 months
What is the minimum time period covered by data at submission for accelerated stability testing?
What is the minimum time period covered by data at submission for accelerated stability testing?
If the long-term condition is 25°C ± 2°C/40% RH ± 5% RH, what is the intermediate condition?
If the long-term condition is 25°C ± 2°C/40% RH ± 5% RH, what is the intermediate condition?
What approach can be developed and reported for non-aqueous, solvent-based products?
What approach can be developed and reported for non-aqueous, solvent-based products?
What does the applicant decide regarding long-term stability studies for drug products?
What does the applicant decide regarding long-term stability studies for drug products?
"If 30°C ± 2°C/35% RH ± 5% RH is the long-term condition, what happens to the intermediate condition?"
"If 30°C ± 2°C/35% RH ± 5% RH is the long-term condition, what happens to the intermediate condition?"
What type of containers should be used when testing drug products for stability under low relative humidity conditions?
What type of containers should be used when testing drug products for stability under low relative humidity conditions?
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