Stability Studies

Stability Studies

Comprehensive Stability Testing Services Ensuring Regulatory Compliance

We offer testing on a range of stability testing, including the most commonly used 5 ±3°C, 25°C/60%, 30°C/65%RH, and 40°C/75%RH. We conduct stability studies at all stages of product development. Krins will ensure that stability studies methodology comply with ICH, US-FDA, and Health Canada and other relevant regulatory requirements/recommendations. Our commitment extends beyond standard stability testing, encompassing rigorous adherence to ICH, US-FDA, and Health Canada guidelines. We provide meticulous oversight at every stage, safeguarding product efficacy and safety.

Our Service Portfolio Includes

Stability Protocol Design and Execution

Formulation Evaluation Stability Studies

Forced Degradation Studies Design and Execution

Stability Testing for R&D Stages (IND, NDA, ANDA)

Development-Validation of Stability Indicating Methods

Commercial / Post-Market Stability Studies

Stability Studies Summary Report Preparation

Customized Conditional Stability Studies

Long Term Stability Studies

Intermediate Stability Studies

Accelerated Stability Studies

Photo-stability Studies

OOT and OOS Trending Reports

Customized Data Recording and Reporting

Freeze/Thaw Studies

Transportation Stability Studies

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