Analytical/Process Validation

In our state-of-the-art R&D labs at Cambrex, our chemists design synthetic routes to your target molecules and develop them to optimal commercial processes. The development and validation of analytical methods run parallel with the synthetic development to provide rapid enabling of your project.

Process Validation Capabilities

• Establishing validation protocols
• Analytical method development
• Range finding for critical process parameters
• Optimization/design of experiments
• Laboratory reproducibility studies
• Scale-up and technology transfer
• Validation summary reports
• Active change control system to ensure continued validated operation

Analytical Validation Capabilities

• Stability indicating and focused degradation studies
• Impurity and limit tests
• Impurity isolation and identification
• Method validation transfers