This function focuses on evaluating the long-term and accelerated stability of APIs, intermediates, and drug products under the environmental conditions defined by ICH Climatic Zones I–IV. The studies provide critical data for shelf-life determination, formulation optimization, and regulatory compliance.
Key Deliverables
- Long-term & Accelerated Stability Testing: Conducting studies under ICH-prescribed temperature and humidity conditions for all climatic zones.
- Stress and Photostability Testing: Assessing product robustness under light, heat, and oxidative stress conditions.
- Shelf-life & Expiry Determination: Generating stability data to support expiry dating and storage conditions.
- Degradation Product Analysis: Monitoring formation of impurities, degradation products, and potency loss over time.
- Regulatory-Compliant Reporting: Preparing comprehensive stability reports for IND, NDA, ANDA, DMF, and other submissions.
- Support for Formulation & Packaging Decisions: Data-driven recommendations for container closure systems and formulation adjustments to ensure stability across regions.