Institute for International Research

Learning Objectives:

• Understand API and dosage form factors that impact sample preparation and extraction
  
• Prepare to implement new UPS <Chapter 467> residual solvent testing guidelines
  
• Learn how to apply results of forced degradation based on the compound chemistry
  
• Analyze the limitations and advantages of orthogonal techniques when applied to the identification and characterization of impurities
  
• Select appropriate columns with different selectivity to optimize critical pair separation
  
• Gain a greater understanding on the regulatory views for control of genotoxic impurities for improved compliance
  
• Develop sensitive and selective analytical methods to detect/quantify low level impurities with genotoxicity potential
  
• Implement concise method validation approaches for ICH and USP compliance
  
• Understand the HPLC columns available today and how they can lead to faster analysis times.
  
• Grasp the benefits of using sub-2 micron particles with modified conventional HPLC and compare to current U-HPLC technology
  
• Explore strategies and metrics for rapid development of robust methods
  
• Identify how a mechanistic understanding of method variables improves robustness
  
• Discover if API recovery and mass balance is critical criteria for an acceptable stability-indicating method
  
• Apply strategic validation tools to your method development and validation process
  
• Chemical Design for Six Sigma (CDFSS) tools that can be applied for analytical method development, validation, and transfer