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.

This is a completely revised and updated sequel to 'A Practical Approach to Chiral Separations by Liquid Chromatography' by the same editor. The scope has been extended to further chiral separation techniques like electrophoresis, membrane separations, or biological assays. More emphasis is put on preparative separation techniques. From reviews of the previous edition: 'A team of experts from academic and industrial laboratories throughout the world have compiled their findings and experience to make this book an exceptionally timely and unique contribution to the field' European Journal of Drug Metabolism 'The dense mass of information contained in this book will make it a valuable resource ...' Chemical Engineering Research '... this is a worthwhile addition to the expanding chiral literature and the book should be of value to those working in this field' The Analyst

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

What drives a scientist to edit a book on a speci c scienti c subject such as chiral mechanisms in separation methods? Until December 2005, the journal Analytical Chemistry of the American Chemical Society (Washington, DC) had an A-page section that was dedicated to simple and clear presentations of the most recent te- niques or the state of the art in a particular eld or topic. The “A-page” section was prepared for a broad audience of chemists including industrial professionals, s- dents as well as academics looking for information outside their eld of expertise. 1 Daniel W. Armstrong, one of the editors of this journal and a twenty-year+ long friend, invited me to present my view on chiral recognition mechanisms in a simple and clear way in an “A-page” article. In 2006, the “A-page” section was maintained as the rst articles at the beginning of each rst bi-monthly issue but the pagination was no longer page distinguished from the regular research articles published by the journal. During the time between the invitation and the submission, the A-page section was integrated into the rest of the journal and the article appeared as (2006) Anal Chem (78):2093–2099.

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. ​