Pharmaceutical Test Report
Report Title: Stability Testing Report for PainAway Relief Tablet
Report Number: STR-2024-001
Date: October 7, 2050
Prepared by: [Your Name], Quality Assurance Analyst
Approved by: Rocky Orn, Senior Quality Manager
Company Name: [Your Company Name]
Address: [Your Company Address]
Contact Information: [Your Company Email]
1. Introduction
This report summarizes the stability testing conducted on the PainAway Relief Tablet, a pain management oral tablet formulation, to evaluate its quality over time under specified storage conditions.
2. Objective
The objective of this study was to determine the stability of the PainAway Relief Tablet under controlled room temperature (25°C ± 2°C, 60% RH ± 5%) and accelerated conditions (40°C ± 2°C, 75% RH ± 5%) for a period of 12 months.
3. Test Methodology
3.1 Sample Information
Product Name: PainAway Relief Tablet
Batch Number: 2024-PA-001
Manufacturing Date: June 1, 2024
Expiry Date: May 31, 2026
3.2 Testing Conditions
Storage Temperature: 25°C ± 2°C / 40°C ± 2°C
Relative Humidity: 60% RH ± 5% / 75% RH ± 5%
Test Duration: 0, 3, 6, and 12 months
3.3 Test Parameters
4. Results
Test Parameter | Initial Value | 12 Months | Specification | Conclusion |
|---|
Appearance | White tablet | No change | Pass | Pass |
Assay (active ingredient) | 500 mg | 485 mg | 90% - 110% | Pass |
pH | 6.5 | 6.2 | 5.5 - 7.0 | Pass |
Dissolution | 90% in 30 min | 85% | NLT 80% | Pass |
Microbial Limits | <10 cfu/g | <10 cfu/g | NMT 100 cfu/g | Pass |
5. Discussion
The stability study of PainAway Relief Tablet demonstrates that the product remains within acceptable limits for all tested parameters over the specified duration. Minor changes were observed in the assay results, but they remain within the established specifications (all results above 90%). The dissolution profile indicates that the product continues to meet the necessary release criteria, maintaining effective delivery of the active ingredient.
6. Conclusion
Based on the results of this stability testing, it is concluded that PainAway Relief Tablet is stable under the specified storage conditions for 12 months. Further testing is recommended at extended intervals to ensure continued compliance with quality specifications.
7. Recommendations
Continue monitoring stability at regular intervals beyond 12 months.
Consider a long-term study at refrigerated conditions (4°C) to evaluate extended shelf life.
Review packaging materials to ensure they maintain integrity under all recommended storage conditions.
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