
Practical Process Research and Development
A guide for Organic Chemists
Description
Key Features
- Provides insights into generating rugged, practical, cost-effective processes for the chemical preparation of "small molecules"
- Breaks down process optimization into route, reagent and solvent selection, development of reaction conditions, workup, crystallizations and more
- Presents guidelines for implementing and troubleshooting processes
Readership
Industrial (primarily organic) chemists, and academicians (particularly those involved in a growing number of start-up companies) and students who need insight into industrial process R&D.
Table of Contents
Chapter 1. Introduction
I Introduction
II Equipment Considerations on Scale
III Operations Preferred on Scale
IV Patent Considerations
V Summary and Perspective
Chapter 2. Process Safety
I Introduction
II Repercussions of Using Compounds Regarded as Environmental Hazards
III Toxicological Hazards of Compounds
IV Controlling Chemical Reaction Hazards
V Perspective on SAFETY
Chapter 3. Route Selection
I Introduction
II Green Chemistry Considerations
III Biotransformations
IV Sleuthing to Determine Routes used to Make Drugs
V COG Estimates
VI Summary and Perspective
Chapter 4. Reagent Selection
I Introduction
II Biocatalysis
III Strong Bases
IV Phase-Transfer Catalysis
V Peptide Coupling
VI Oxidations
VII Reductions
VIII Treatments to Remove a Boc Group
Chapter 5. Solvent Selection
I Introduction
II Using Azeotropes to Select Solvents
III Choosing Solvents to Increase Reaction Rates and Minimize Impurities
IV Impurities in Solvents and Reactions of Solvents
V Water as Solvent
VI Solvent Substitutions
VII Solvent-Free Processes
VIII Summary and Perspective
Chapter 6. Effects of Water
I Introduction
II Detecting and Quantitating Water
III Removing Water from Routine Organic Processing
IV Where to Monitor and Control Water
V Operations to Remove or Consume Water
VI Operations Where Water can be Crucial
VII Perspective
Chapter 7. In-Process Assays, In-Process Controls, and Specifications
I Introduction
II Understanding Critical Details Behind In-Process Assays
III Benefits of In-Process Assays In Optimizing Processes
IV In-Process Controls
V Specifications
VI Process Analytical Technology
VII Summary and Perspective
Chapter 8. Practical Considerations for Scale-Up
I Introduction
II SAFETY: Inert Atmospheres Reduce Risks
III Temperature Control
IV Heterogeneous Processing and Considerations for Agitation
V Additions and Mixing Considerations
VI Solvent Considerations
VII Simple Procedures
VIII Impact of IPCs on Processing
IX Consider the Volatility of Reaction Components, and Use of Pressure
X Practical Considerations for Efficient Workups and Isolations
XI Additional Considerations for Kilo Lab Operations
XII Summary and Perspective
Chapter 9. Optimizing Processes by Minimizing Impurities
I Introduction
II Benefits and Limitations of Heterogeneous Processing
III Decrease Side Products by Decreasing Degradation of Starting Materials
IV Controlling pH
V Addition Sequence, Duration of Addition, and Time Between Additions
VI Temperature Control
VII Minimizing Impurities Formed During Workup
VIII Factors Affecting Hydrogenations
IX Statistical Design of Experiments
X Reaction Kinetics
XI Alternative Addition Protocols, or Continuous Processing
XII Perspective
Chapter 10. Optimizing Organometallic Reactions
I Introduction
II Chemical Activation to Improve Reaction Conditions
III Operations to Minimize Side Reactions
IV Impact of Impurities
V Some Considerations for Heterogeneous Reactions
VI Perspective and Summary
Chapter 11. Workup
I Introduction
II Quenching Reactions
III Extractions
IV Treatment With Activated Carbon and Other Absorbents
V Filtration to Remove Impurities
VI Removing Metal Salts and Metals
VII Quenching and Working Up Biocatalytic Reactions
VIII Chromatography
IX Perspective on Workup
Chapter 12. Crystallization and Purification
I Introduction
II Slow Application of Crystallization Pressure, and Seeding
III Crystallization by Cooling
IV Crystallization by Concentrating
V Crystallization by Adding an Antisolvent
VI Reactive Crystallization
VII Handling and Isolating Water-Soluble Products
VIII Polymorphs
IX Processing Enantiomeric Crystals
X Guidelines for a Practical Crystallization
XI Perspective
Chapter 13. Final Product Form and Impurities
I Introduction
II Physicochemical Considerations in APIs and Final Form Selection
III Impurity Considerations in APIs
IV Genotoxic Impurities
V Stability of Drug Substance
VI Perspective and Summary
Chapter 14. Continuous Operations
I Introduction
II Microreactors and Small-Diameter Tubing for Scale-Up
III Continuous Operations using Tubing or Reactors of Larger Diameter
IV Summary and Perspective
Chapter 15. Refining the Process for Simplicity and Ruggedness
I Introduction
II The Importance of Mass Balances
III Documenting a Process for Technology Transfer
IV Case Studies on Refined Processes
V Summary and Perspective
Chapter 16. Process Validation and Implementation
I Introduction
II Laboratory Investigations Focused on Process Implementation
III Activities Prior to Introducing a Process to the Pilot Plant or Manufacturing Plant
IV Actions During Process Implementation
V Cleaning and Removing Water from Processing Equipment
VI Follow-Up After Process Introduction
VII Managing Outsourcing
VIII Summary and Perspective
Chapter 17. Troubleshooting
I Introduction
II Perspective
Product details
- No. of pages: 488
- Language: English
- Copyright: © Academic Press 2012
- Published: August 9, 1973
- Imprint: Academic Press
- Paperback ISBN: 9781493301256
- eBook ISBN: 9780123865380
About the Author
Neal Anderson
Affiliations and Expertise
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