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Dedication to Safety, Efficacy & Quality
The FDA recommends that all assay procedures for BUD/stability studies should be stability-indicating. The main objective of a stability-indicating method is to monitor results during stability studies to guarantee the safety, efficacy, and quality of the product. It also represents a powerful tool when investigating out-of-trend (OOT) or out-of-specification (OOS) results in quality control processes.
Validation Services
- Stability Indicating Method Development and Validation
- Method Verification
- Compendial (USP/EP/JP/BP) Procedures
- Method Transfer of Pre-Validated Analytical Methods
- Process Validation
- Stability Studies per ICH Guidelines Q1A(R2)
Study | Storage Condition |
| Long-term | 25°C ± 2°C/60% RH ± 5% RH |
| Intermediate | 30°C ± 2°C/65% RH ± 5% RH |
| Accelerated | 40°C ± 2°C/75% RH ± 5% RH |
| Refrigerated | 5°C ± 3°C |
Let Our Experience Work For You
Cutting-Edge
Our Laboratories
Eagle’s cutting-edge 80,000-square-foot facility and laboratory are equipped with advanced technologies and specialized segregated laboratory spaces to meet the diverse needs of our clients. This behind-the-scenes video provides you with an opportunity to witness testing while touring our laboratory.