Chiral Separation Methods For Pharmaceutical And Biotechnological Products

Discusses chiral separations and offers guidance for selecting the optimum method for desired results Chiral separations represent the most intriguing and, by some measures, most difficultseparations of chemical compounds. This book provides researchers and students an under-standing of chiral separations and offers a convenient route to selecting the best separation method, saving considerable time and cost in product development. Considering chiral separations in the biotechnological and pharmaceutical industries, as well as for food applications, Dr. Ahuja provides insights into a broad range of topics. Opening with a broad overview of chiral separations, regulatory considerations in drug product development, and basic issues in method development, the book: Covers a variety of modern methods such as gas chromatography, high performance liquid chromatography, supercritical fluid chromatography, and capillary electrophoresis Deals with the impact of chirality on the biological activity of small and large molecules Provides detailed information on useful chiral stationary phases (CSPs) for HPLC Includes handy information on selection of an appropriate CSP, including mechanistic studies Offers strategies for fast method development with HPLC, SFC, and CE Discusses preparatory methods utilized in the pharmaceutical industry With in-depth discussions of the current state of the field as well as suggestions to assist future developments, Chiral Separation Methods for Pharmaceutical and Biotechnological Products is an essential text for laboratory investigators, managers, and regulators who are involved in chiral separations in the pharmaceutical industry, as well as students preparing for careers in these fields.

Thoroughly revised, with either entirely new or completely updated contents, this is a practical manual for the small and large-scale preparation of enantiomerically pure products. The result is a vital resource for meeting the highest purity standards in the manufacture of chiral pharmaceuticals, food additives and related compounds. All the approaches covered here are highly relevant to modern manufacturing and quality control schemes in the pharmaceutical and biotech industries, addressing the increasingly important issue of drug safety in view of tougher regulatory standards worldwide.

Authored by a team of respected scientists and technologists, this book covers many pharmaceutical and biotechnology separations methods currently in use. Practical applications and descriptions are offered for air elutriation, microporous filtration, ultrafiltration, phase partitioning, crystallization, and chromatographic technologies such as adsorption, affinity, chelate, ion-exchange, size-exclusion, template, hydrophobic interaction, biotransformations, and chiral separations. Containing hundreds of references and a complete index, this book is designed for research and development scientists, process optimization engineers, and quality control laboratory scientists as well as quality assurance professionals and others needing to understand current separation techniques.

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. Presents a critical assessment of the application of ICH guidelines on method validation and specification setting Written by subject-matter experts involved in the development and application of the guidelines Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction

Liquid Chromatography: Applications, Second Edition,is a single source of authoritative information on all aspects of the practice of modern liquid chromatography. It gives those working in both academia and industry the opportunity to learn, refresh, and deepen their knowledge of the wide variety of applications in the field. In the years since the first edition was published, thousands of papers have been released on new achievements in liquid chromatography, including the development of new stationary phases, improvement of instrumentation, development of theory, and new applications in biomedicine, metabolomics, proteomics, foodomics, pharmaceuticals, and more. This second edition addresses these new developments with updated chapters from the most expert researchers in the field. Emphasizes the integration of chromatographic methods and sample preparation Explains how liquid chromatography is used in different industrial sectors Covers the most interesting and valuable applications in different fields, e.g., proteomic, metabolomics, foodomics, pollutants and contaminants, and drug analysis (forensic, toxicological, pharmaceutical, biomedical) Includes references and tables with commonly used data to facilitate research, practical work, comparison of results, and decision-making

Essentials in Modern HPLC Separations, Second Edition discusses the role of separation in high performance liquid chromatography (HPLC). This new and updated edition systematically presents basic concepts as well as new developments in HPLC. Starting with a description of basic concepts, it provides important guidance for the practical utilization of various HPLC procedures, such as the selection of the HPLC type, proper choice of the chromatographic column, selection of mobile phase and selection of the method of detection, all of which are in correlation with the physico-chemical characteristics of the compounds separated. Every chapter has been carefully reviewed, with several new sections added to bring the book completely up-to-date. Hence, it is a valuable reference for students and professors in chemistry. Provides a thoroughly updated resource, with an entirely new section on Computer-aided Method Development in HPLC and new subsections on miniaturization and automation in HPLC, chemometric aspects of HPLC, green solvent use in HPLC, and more Includes insights into the chromatographic process to find the optimum solution for analyzing complex samples Presents a basis for understanding the utilization of modern HPLC for applications, particularly for the analysis of pharmaceutical, biological, food, beverage and environmental samples

There is a demand for analytical methods that are able to discriminate between enantiomers in order to analyze the enantiomeric purity of compounds from natural or chemical sources not only in pharmaceutical sciences but in any field on bioactive compounds including chemistry, biology, biochemistry, forensic, and environmental sciences and many others. The second edition of Chiral Separations: Methods and Protocols, expands upon the previous edition with current methodology, providing an overview and especially practically oriented applications of the most important analytical techniques in chiral separation sciences. New chapters on analytical separation sciences by chromatographic and electrophoretic techniques have been added as has simulated moving bed chromatography as a preparative method. Written in the highly successful Methods in Molecular BiologyTM series format, the chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Chiral Separations: Methods and Protocols, Second Edition is helpful for analytical chemists working on stereochemical problems in fields or pharmacy, chemistry, biochemistry, food chemistry, molecular biology, forensics, environmental sciences or cosmetics in academia, government or industry.

This book highlights the morphology-property relationship of regenerated cellulose materials and composites, as morphology of materials is the key feature and corresponds to associated applications of/to the materials. It is highly essential to assimilate the literature on morphology-property relationship of cellulose materials. Being the most abundant natural polymer on earth and gateway to large number of applications, cellulose is expected to be researched for higher efficiencies. Various books and research articles have targeted the specific morphologies, the respective characteristics and application areas. This book presents literature on morphology-property relationship of cellulose materials and provides a direction to this relationship. ​