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.
- Stability Indicating Method Development and Validation
- Method Verification
- Compendial (USP/EP/JP/BP) Procedures
- Method Transfer of Pre-Validated Analytical Methods
- Stability Studies per ICH Guidelines Q1A(R2)
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
- Process Validation
- Disinfectant Efficacy Testing
- Cleaning Validation
Eagle’s cutting-edge 35,000-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.
Your Future Awaits
Our talents vary — but we all have the same drive: to find better ways to improve the lives around us. If you are looking to become part of a company that is growing and innovative, Eagle may just be what you are looking for.
Got Micro needs? Ready to get started?
Call the Eagle Client Care Team at 800.745.8916 to request an initial consultation and discuss your operation’s specific needs.