Complete Mebendazole stability data package with ICH guidelines compliance, shelf life determination for all climate zones, and comprehensive testing results for global regulatory submissions.
Our comprehensive stability testing program follows ICH Q1A(R2) guidelines and provides complete stability data for Mebendazole tablets across all ICH climate zones. The data supports 36-month shelf life under recommended storage conditions.
| Climate Zone | Conditions | Testing Duration | Shelf Life | Storage Conditions | Results |
|---|---|---|---|---|---|
| Zone II | 25°C/60% RH | 36 months | 36 months | Room temperature | Meets specifications |
| Zone III | 30°C/65% RH | 36 months | 36 months | Ambient temperature | Meets specifications |
| Zone IVa | 30°C/75% RH | 36 months | 36 months | Warm climate | Meets specifications |
| Zone IVb | 40°C/75% RH | 36 months | 36 months | Hot & humid climate | Meets specifications |
| Time (months) | Assay (%) | Dissolution (%) | Hardness (kp) |
|---|---|---|---|
| 0 (Initial) | 100.2 | 98.5 | 6.2 |
| 3 | 99.8 | 98.2 | 6.1 |
| 6 | 99.5 | 97.8 | 6.0 |
| 12 | 99.2 | 97.5 | 5.9 |
| 18 | 98.9 | 97.2 | 5.8 |
| 24 | 98.6 | 96.9 | 5.7 |
| 36 | 98.3 | 96.5 | 5.6 |
| Time (months) | Assay (%) | Dissolution (%) | Hardness (kp) |
|---|---|---|---|
| 0 (Initial) | 100.2 | 98.5 | 6.2 |
| 3 | 99.6 | 97.9 | 6.0 |
| 6 | 99.1 | 97.3 | 5.8 |
| 12 | 98.5 | 96.8 | 5.6 |
| 18 | 98.0 | 96.3 | 5.4 |
| 24 | 97.5 | 95.8 | 5.2 |
| 36 | 97.0 | 95.2 | 5.0 |
| Time (months) | Assay (%) | Dissolution (%) | Hardness (kp) | Friability (%) | Appearance |
|---|---|---|---|---|---|
| 0 (Initial) | 100.2 | 98.5 | 6.2 | 0.45 | White, no defects |
| 1 | 99.8 | 98.0 | 6.0 | 0.48 | White, no defects |
| 2 | 99.4 | 97.5 | 5.8 | 0.52 | White, no defects |
| 3 | 99.0 | 97.0 | 5.6 | 0.55 | White, no defects |
| 6 | 98.2 | 96.0 | 5.2 | 0.62 | White, no defects |
Accelerated stability data shows excellent stability characteristics with no significant degradation over 6 months at 40°C/75% RH. All parameters remain within specification limits, supporting the proposed 36-month shelf life.
| Test Conditions: | 1.2 million lux hours UV, 200 watt hours/m² visible |
| Duration: | Exposure for 1.2 million lux hours |
| Assay Change: | <2% degradation |
| Degradation Products: | Within acceptable limits |
| Physical Changes: | No significant color or appearance changes |
| Conclusion: | Photostable |
| Test Conditions: | 60°C, 75% RH for 14 days |
| Assay Change: | <5% degradation |
| Dissolution: | Within 5% of initial value |
| Hardness: | No significant change |
| Friability: | Within specification limits |
| Conclusion: | Thermally stable |
Minor hydrolytic degradation observed under extreme humidity conditions. Degradation products are well-characterized and within acceptable limits.
Minimal photolytic degradation under accelerated photostability conditions. Product demonstrates excellent photostability characteristics.
Thermal stability maintained up to 60°C. No significant thermal degradation pathways identified under normal storage conditions.
Excellent oxidative stability with no significant oxidation products detected under stress testing conditions.
| Packaging Type: | PVC/Aluminum blister |
| Water Vapor Transmission: | <0.1 g/m²/24h |
| Oxygen Transmission: | <0.05 cm³/m²/24h |
| Light Protection: | Aluminum foil backing |
| Stability: | 36 months confirmed |
| Climate Suitability: | All climate zones |
| Packaging Type: | Aluminum/Aluminum |
| Water Vapor Transmission: | <0.01 g/m²/24h |
| Oxygen Transmission: | <0.005 cm³/m²/24h |
| Light Protection: | Complete light barrier |
| Stability: | 36 months confirmed |
| Climate Suitability: | Hot & humid climates |
Linear regression analysis of assay and dissolution data shows <5% degradation over 36 months across all climate zones, meeting ICH acceptance criteria.
All critical quality attributes remain within specification limits throughout the 36-month testing period under all ICH climate conditions.
Significant safety margin built into shelf life determination with degradation rates well below regulatory limits.
Protective packaging systems (blister and Alu-Alu) provide excellent barrier properties against moisture, oxygen, and light.
Proposed Shelf Life: 36 months from date of manufacture
Storage Conditions: Store below 30°C, protect from moisture and light
Climate Zone Coverage: Zones II, III, IVa, and IVb
Regulatory Acceptance: Accepted by major regulatory authorities worldwide
| Format: | PDF, Excel, and raw data files |
| Language: | English (with translation options) |
| Delivery: | Secure electronic transfer |
| Updates: | Regular stability updates provided |
| Support: | Technical support for data interpretation |
| Customization: | Country-specific format available |
Obtain our comprehensive Mebendazole stability data package with ICH compliance for all climate zones. Complete documentation for your regulatory submissions worldwide.
Complete Common Technical Document with Module 1-5 structure for regulatory submissions.
CTD DossierCertificate of Pharmaceutical Product for international trade and regulatory compliance.
COPP CertificateWHO-GMP certified manufacturing facilities and quality compliance information.
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