I Synthetic route discovery and selection
- The evolution of chemical synthesis from laboratory to industrial scale.
- Lab versus Industrial synthesis.
- Organic drug synthesis The ideal process.
- Synthetic route discovery and selection. Patents.
II Hazards in industrial synthesis
- Major areas: toxicity, fire/explosion and chemical reaction Major accident causes.
- Hazards in process development and scale-up. Process safety.
- Thermal hazards: thermal stability and explosiveness of compounds and mixtures.
- Gas generation. Process abnormalities.
III Process Development and scale-up (batch)
- Main strategy: individual step study, integration of individual steps and global.
- Individual step development: the chemical transformation, the work-up, the isolation and purification of the product. Polymorphism and chiral synthesis.
IV Analysis
- In-process control and API characterization.
- Polymorphism, enantiomeric.
- API stability and specifications.
