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Stability Testing Report: Vitamin D Capsules
Report
Stability Testing Report: Vitamin D Capsules:
Batch Details:
• Product Name: Vitamin D 1000 IU Softgel Capsules
• Batch No.: VD-2024-003
• Batch Size: 250,000 capsules
• Storage Conditions:
o Long-Term Stability: 25°C / 60% RH (12 months)
o Accelerated Stability: 40°C / 75% RH (6 months)
Stability Testing Results:
Assay (Potency):
Initial Value: 100%
After 6 Months (40°C): 92%
After 12 Months (25°C): 97%
Moisture Content:
Initial Value: 2.0%
After 6 Months (40°C): 3.5%
After 12 Months (25°C): 2.8%
Microbial Limit:
Initial Value: Within Spec
After 6 Months (40°C): Within Spec
After 12 Months (25°C): Within Spec
Conclusion:
Vitamin D capsules remained stable under long-term and accelerated conditions. The product met ICH Q1A guidelines, confirming a 24-month shelf-life under ambient conditions.
Stability testing ensures pharmaceutical products remain safe and effective throughout their shelf life. This project evaluates the stability of Vitamin D capsules under both long-term and accelerated conditions to determine how environmental factors affect product integrity.