Equipped with technologically advanced processes and analytical instrumentation, our scientists support all your hazard evaluation needs, offering integrated, continuous service through the drug development life cycle.
During early process development, AMRI’s experts conduct a safety evaluation to identify potential issues during scale-up. At that stage and based on our evaluation, we redesign the processes to address all potentially hazardous issues. Backed by experienced process scientists and engineers, the new processes are then demonstrated with fixed equipment in the kilo lab to prove robustness.
AMRI’s experts go beyond sample analysis to fix hazardous processes. Leverage our decades of experience in developing safe, efficient and robust processes to help you fulfill your API supply needs.
Our capabilities include:
- Thermal stability assessment: Includes accelerating rate calorimetry (ARC), differential scanning calorimetry (DSC), high-pressure DSC and use of thermal screening unit
- Reaction calorimetry: 200 to 1600 mL, -25 to 200 oC; 0–60 bar; headspace analysis and vent sizing package (VSP2)
- Impact sensitivity testing for potentially explosive compounds: Includes DSC screening and BAM Fallhammer test; routine assessment of impact sensitivity of all compounds exceeding 800 J/g)
- Extensive risk-based assessment sheet: Based on our thorough analysis, a detailed report summarizing the results is provided; we then develop processes to address all concerns