Cyanta provides both long and short-term stability storage and analytical services including validation of stability indicating assays. Our stability and validation services are also designed to support your product from predevelopment through commercialization.
Method Validation
Our method development and validation services include:
- Analytical method validation for potency, dissolution, degradants, impurities, moisture, metals, residual solvents and other physical/chemical tests
- Stability indicating methods for APIs
- Development of cleaning validation methods
- Analytical method validations per ICH guidelines
- Process validation (synthetic process support/finished product manufacturing support, including test points)
Stability Storage
Cyanta specializes in a in providing stability storage under ICH guidelines for a variety of storage conditions. Our stability conditions include:
| Temperature (Celsius) | Humidity |
| 25 | 60 |
| 30 | 60 |
| 30 | 65 |
| 40 | 75 |
| 5 | Controlled Humidity |
Additional conditions can be provided on an as needed basis.
We specialize in providing storage and analytical support for the following:
- API
- Finished drug products
- Medical device
- QC release