- Packing, Storage, and Stability Testing ensure drug protection by using suitable containers and environmental controls to preserve efficacy and safety.
- Packing, Storage, and Stability Testing help determine a product’s shelf life by assessing its physical, chemical, and microbiological stability under various conditions.
Packing:
- Soft gelatin capsules are packed in moisture-proof containers to prevent degradation.
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Common packing materials:
- Blister Packs: Made of aluminum or PVC for individual capsules.
- Bottles: For bulk packaging with desiccants to absorb moisture.
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Storage:
- Stored at a temperature of 15-25°C with a relative humidity of 35-45
- Avoid exposure to direct sunlight, high temperatures, or excessive moisture.
Stability Test:
- Performed under different conditions to assess:
- Physical Stability: Retention of capsule shape, size, and integrity.
- Chemical Stability: Drug degradation and compatibility with the shell.
- Microbial Stability: Resistance to microbial contamination over time.
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