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Validation Services
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.
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Validation Services
- 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)
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 - Process Validation
- Disinfectant Efficacy Testing
- Cleaning Validation
![3O1A8000-37 A microbiologist looking at a contact plate under a magnifying glass.](https://eagleanalytical.com/wp-content/uploads/2022/02/3O1A8000-37-scaled.jpg)
OUR LABORATORIES
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.
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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.