Contact SRI Biosciences

Drug Substance Preparation

SRI chemists have a clear understanding that a clean, economical synthesis process is imperative for a new drug to be successful in a competitive market. We design processes with overall safety as the first priority and look to substitute potentially hazardous routes that were useful for lab bench-scale syntheses with safe, scalable routes. Other considerations include: acceptable reaction solvents, readily available reagents, economic purification methods, minimization of waste stream environmental impact.

We perform

• Scale-up feasibility studies
• Scale-up of existing processes
• Process development
• Process optimization
• Reference standard synthesis with certificates of analysis for
  • Drug substance
  • Production impurities
  • Degradation products identified from stability studies
  • Metabolites identified in PK/ADME studies
• Analytical methods development and validation
• Quality control and quality assurance support
• Technology transfer

Contact Us
     Last Updated Jan 25, 2010