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Commercial Production
Discovery Support
Process R&D
Clinical Supply
Regulatory Support
Special Manufacturing

Analytical Method Research, Development, and Validation

  • In-Process Controls
  • Raw Materials Testing
  • Intermediates and Final Product Testing
  • Cleaning Test Methods
  • Residual Solvents
  • Solid State Materials Characterization
    • Polymorphism
    • Crystal form (Solvates, Clathrates, etc.)
    • Crystal characteristics
  • Impurity Characterization/Detection
  • Spectroscopic, Physical and Thermal Analysis
  • Reference Standards
  • Specifications (Raw Materials, Intermediates, and Final Product)
  • Vendor Qualification
  • Test Methods for Waste Streams
  • Release Testing
  • Stability Evaluation for
    • Process Streams
    • Intermediates
    • Raw Materials
    • Final Product

 

 

 
   

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