Crystallization of Organic Compounds An Industrial Perspective

Practical resource covering applications of crystallization principles with methodologies, case studies, and numerous industrial examples for emphasis

Based on the authors’ hands-on experiences as process engineers, through the use of case studies and examples of crystallization processes, ranging from laboratory development through manufacturing scale-up, Crystallization of Organic Compounds guides readers through the practical applications of crystallization and emphasizes strategies that have proven to be successful, enabling readers to avoid common pitfalls that can render standard procedures unsuccessful.

Most chapters feature multiple examples that guide readers, step by step, through the crystallization of active pharmaceutical ingredients (APIs), including an analysis of the major methods of carrying out crystallization operations, their strengths and potential issues, as well as numerous examples of crystallization processes from development through manufacturing scale.

Advancements in the field of crystallization have been integrated throughout the book in the newly revised Second Edition to ensure the content adequately reflects current state-of-the-art industrial know-hows and practice. The new edition also adds chapters addressing downstream operations after the crystallization, including filtration/washing and drying, together with industrial use cases.

Crystallization of Organic Compounds includes detailed information on:

• Solubility and solid behavior, covering phase rule, polymorph, salt/co-crystal, chiral resolution and in-silico solubility prediction; and kinetics, covering seed, supersaturation, nucleation, crystal growth and model-based experimental design
• Critical issues in the crystallization practice, covering oiling out, seeding/wet-milling, agglomeration/aggregation, mixing scale-up and quality-by-design principles
• Cooling, anti-solvent, evaporation and reactive crystallization process design, covering batch and continuous operations with industrial examples
• Special applications, covering crystallization with ultrasound, reaction selectivity enhancement, and computation fluid dynamics, and solid dispersion

With highly practical coverage of the subject, Crystallization of Organic Compounds is an essential resource for engineers and chemists involved with the development, scaling, or operation of crystallization process in the pharmaceutical and fine chemical industries, particularly those with degrees in chemical engineering and chemistry.

Hsien-Hsin Tung, PhD, is the co-founder of AcrysPharm, LLC. He founded the crystallization lab. at Merck and center of excellence of particle engineering at Abbive.

Edward L. Paul, PhD, (deceased) was retired Director of Chemical Engineering R & D at Merck Research Laboratories.

Michael Midler, PhD, (deceased) was retired Senior Investigator, Chemical Engineering R&D at Merck.

James A. McCauley, PhD, was a senior investigator in the Analytical R & D at Merck until his retirement, after which he became an adjunct professor in the Department of Chemical and Biochemical Engineering at Rutgers University.

Preface

Chapter 1            Introduction to Crystallization

Chapter 2            Properties

Chapter 3            Polymorphism

Chapter 4            Kinetics

Chapter 5            Mixing and Crystallization

Chapter 6            Critical Issues and Quality by Design

Chapter 7            Cooling Crystallization

Chapter 8            Evaporative Crystallization

Chapter 9            Antisolvent Crystallization

Chapter 10          Reactive Crystallization

Chapter 11          Filtration

Chapter 12          Drying

Chapter 13          Special Applications

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