Development of Novel Stability Indicating Methods Using Liquid Chromatography
Development of Novel Stability Indicating Methods Using Liquid Chromatography

Author: Mukesh Maithani

Publisher: Springer

Published: 2019-08-07

Total Pages: 117

ISBN-13: 9811387230

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Reversed-phase high-performance liquid chromatography (RP-HPLC) has become the most widely used method for pharmaceutical analysis, as it ensures accuracy, specificity and reproducibility for the quantification of drugs, while avoiding interference from any of the excipients that are normally present in pharmaceutical dosage forms. This book presents a simple methodology for developing stability-indicating methods and offers a ‘how-to guide’ to creating novel stability-indicating methods using liquid chromatography. It provides the detailed information needed to devise a stability-indicating method for drug substances and drug products that comply with international regulatory guidelines. As such, it is a must-read for anyone engaged in analytical and bioanalytical chemistry: professionals at reference, test, and control laboratories; students and academics at research laboratories, and scientists working for chemical, pharmaceutical, and biotechnology companies.

Practical HPLC Method Development
Practical HPLC Method Development

Author: Lloyd R. Snyder

Publisher: Wiley-Interscience

Published: 1988

Total Pages: 296

ISBN-13:

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Designed for the professional chemist who is already familiar with the basics of high performance liquid chromatography, this book explains how to develop separation methods for a variety of situations. It focuses on reversed-phase separations of small molecules and development of separations.

Separation Methods in Drug Synthesis and Purification
Separation Methods in Drug Synthesis and Purification

Author: Klara Valko

Publisher: Elsevier

Published: 2020-06-19

Total Pages: 790

ISBN-13: 0444640711

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Separation Methods in Drug Synthesis and Purification, Second Edition, Volume Eight, provides an updated on the analytical techniques used in drug synthesis and purification. Unlike other books on either separation science or drug synthesis, this volume combines the two to explain the basic principles and comparisons of each separation technique. New sections to this volume include enantiomer separation using capillary electrophoresis (CE) and capillary electro- chromatography, the computer simulation of chromatographic separation for accelerating method development, the application of chromatography and capillary electrophoresis used as surrogates for biological processes, and new developments in the established techniques of chromatography and preparative methods. - Features descriptions and applications of all separation methods used in the pharmaceutical industry - Written by the leading scientists in their respective fields, providing solutions for a wide range of industrial separation problems encountered within the pharmaceutical industry - Thoroughly updated with brand new separation science techniques and the latest developments in the established techniques of chromatography

Analytical Method Development and Validation
Analytical Method Development and Validation

Author: Michael E. Swartz

Publisher: CRC Press

Published: 2017-09-28

Total Pages:

ISBN-13: 9781138402560

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Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

Bioanalysis of Pharmaceuticals
Bioanalysis of Pharmaceuticals

Author: Steen Honoré Hansen

Publisher: John Wiley & Sons

Published: 2015-10-08

Total Pages: 336

ISBN-13: 1118716841

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Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry is the first student textbook on the separation science and mass spectrometry of pharmaceuticals present in biological fluids with an educational presentation of the principles, concepts and applications. It discusses the chemical structures and properties of low- and high-molecular drug substances; the different types of biological samples and fluids that are used; how to prepare the samples by extraction, and how to perform the appropriate analytical measurements by chromatographic and mass spectrometric methods. Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry: Is an introductory student textbook discussing the different principles and concepts clearly and comprehensively, with many relevant and educational examples Focuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteins Presents both the basic principles that are regularly taught in universities, along with the practical use of bioanalysis as carried out by researchers in the pharmaceutical industry and in hospital laboratories Is aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciences The book includes multiple examples to illustrate the theory and application, with many practical aspects including calculations, thus helping the student to learn how to convert the data recorded by instruments into the real concentration of the drug substances within the biological sample.

HPLC Method Development for Pharmaceuticals
HPLC Method Development for Pharmaceuticals

Author: Satinder Ahuja

Publisher: Academic Press

Published: 2007

Total Pages: 513

ISBN-13: 9780123705402

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High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge. * Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory * Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities) * Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase

Multidimensional Liquid Chromatography
Multidimensional Liquid Chromatography

Author: Steven A. Cohen

Publisher: John Wiley & Sons

Published: 2008-05-09

Total Pages: 490

ISBN-13: 0470276258

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Multidimensional Liquid Chromatography (MDLC) is a very powerful separation technique for analyzing exceptionally complex samples in one step. This authoritative reference presents a number of recent contributions that help define the current art and science of MDLC. Topics covered include instrumentation, theory, methods development, and applications of MDLC in the life sciences and in industrial chemistry. With the information to help you perform very difficult separations of complex samples, this reference includes chapters contributed by leading experts or teams of experts.

Preparative Chromatography for Separation of Proteins
Preparative Chromatography for Separation of Proteins

Author: Arne Staby

Publisher: John Wiley & Sons

Published: 2017-03-06

Total Pages: 577

ISBN-13: 1119031109

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Preparative Chromatography for Separation of Proteins addresses a wide range of modeling, techniques, strategies, and case studies of industrial separation of proteins and peptides. • Covers broad aspects of preparative chromatography with a unique combination of academic and industrial perspectives • Presents Combines modeling with compliantce useing of Quality-by-Design (QbD) approaches including modeling • Features a variety of chromatographic case studies not readily accessible to the general public • Represents an essential reference resource for academic, industrial, and pharmaceutical researchers

Chiral Separation Methods for Pharmaceutical and Biotechnological Products
Chiral Separation Methods for Pharmaceutical and Biotechnological Products

Author: Satinder Ahuja

Publisher: John Wiley & Sons

Published: 2011-03-31

Total Pages: 474

ISBN-13: 1118097750

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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.