Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals

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Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

Author : Satinder Ahuja
Publisher : Academic Press
ISBN 13 : 9780120449828
Total Pages : 444 pages
Book Rating : 4.4/5 (498 download)

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Book Synopsis Handbook of Isolation and Characterization of Impurities in Pharmaceuticals by : Satinder Ahuja

Download or read book Handbook of Isolation and Characterization of Impurities in Pharmaceuticals written by Satinder Ahuja and published by Academic Press. This book was released on 2003-07-18 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product. This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements. It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.

HB of Isolation and Characterization of Impurities in Pharmaceuticals (HB)

Author : Ahuja
Publisher :
ISBN 13 : 9788181479822
Total Pages : pages
Book Rating : 4.4/5 (798 download)

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Book Synopsis HB of Isolation and Characterization of Impurities in Pharmaceuticals (HB) by : Ahuja

Download or read book HB of Isolation and Characterization of Impurities in Pharmaceuticals (HB) written by Ahuja and published by . This book was released on 2005-06-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Handbook of Modern Pharmaceutical Analysis

Author : Satinder Ahuja
Publisher : Academic Press
ISBN 13 : 0123759811
Total Pages : 604 pages
Book Rating : 4.1/5 (237 download)

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Book Synopsis Handbook of Modern Pharmaceutical Analysis by : Satinder Ahuja

Download or read book Handbook of Modern Pharmaceutical Analysis written by Satinder Ahuja and published by Academic Press. This book was released on 2010-11-11 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Analysis of Drug Impurities

Author : Richard J. Smith
Publisher : John Wiley & Sons
ISBN 13 : 0470994223
Total Pages : 288 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Analysis of Drug Impurities by : Richard J. Smith

Download or read book Analysis of Drug Impurities written by Richard J. Smith and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: A key component of the overall quality of a pharmaceutical is control of impurities, as their presence, even in small amounts, may affect drug safety and efficacy. The identification and quantification of impurities to acceptable standards presents a significant challenge to the analytical chemist. Analytical science is developing rapidly and provides increasing opportunity to identify the structure, and therefore the origin and safety implications of these impurities, and the challenges of their measurement drives the development of modern quantitative methods. Written for both practicing and student analytical chemists, Analysis of Drug Impurities provides a detailed overview of the challenges and the techniques available to permit accurate identification and quantification of drug impurities.

Handbook of Pharmaceutical Analysis

Author : Lena Ohannesian
Publisher : CRC Press
ISBN 13 : 0824741943
Total Pages : 605 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Handbook of Pharmaceutical Analysis by : Lena Ohannesian

Download or read book Handbook of Pharmaceutical Analysis written by Lena Ohannesian and published by CRC Press. This book was released on 2001-11-09 with total page 605 pages. Available in PDF, EPUB and Kindle. Book excerpt: Exploring the analysis of pharmaceuticals, including polymorphic forms, this book discusses regulatory requirements in pharmaceutical product development and pharmaceutical testing. It covers methods of drug separation and procedures such as capillary electrophoresis for chromatographic separation of molecules. Additional topics include drug formulation analysis using vibrational and magnetic resonance spectroscopy and identification of drug metabolites and decomposition products using such techniques as mass spectrometry. The book provides more than 300 tables, equations, drawings, and photographs, and convenient, easy-to-use indices, facilitating quick access to each topic.

Identification and Determination of Impurities in Drugs

Author : S. Görög
Publisher : Elsevier
ISBN 13 : 0080534406
Total Pages : 773 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis Identification and Determination of Impurities in Drugs by : S. Görög

Download or read book Identification and Determination of Impurities in Drugs written by S. Görög and published by Elsevier. This book was released on 2000-05-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Impurity profiling is the common name of a group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. Since this is the best way to characterise the quality and stability of bulk drugs and pharmaceutical formulations, this is the core activity in modern drug analysis.Due to the very rapid development of the analytical methodologies available for this purpose and the similarly rapid increase of the demands as regards the purity of drugs it is an important task to give a summary of the problems and the various possibilities offered by modern analytical chemistry for their solution. That is the aim of this book.The book is methodology-oriented. In the first chapter some important aspects of the background of impurity-related analytical studies (toxicological, pharmacopoeial aspects, the characterisation of the sources of impurities and the role of impurity profiling in various fields of drug research, production and therapeutic use) are summarised. Chapter two deals with related organic impurities, the strategies for impurity profiling, the use of chromatographic and related separation methods, spectroscopic, and hyphenated techniques. The subject of the third chapter is the identification and determination of residual solvents. The determination of inorganic impurities is discussed in chapter four. The special problems of degradation products as impurities are dealt with in chapter five. A separate chapter has been compiled to deal with one of the most up-to-date problems in contemporary pharmaceutical analysis, the estimation of enantiomeric purity of chiral drugs. Chapter seven is devoted to various approaches to solve the problem of polymorphic modifications as impurities. Since in the broader sense of the word the microbiological purity of drugs and drug products also belongs to this circle, the most important information from this field is summarised in chapter eight. After the mainly methodology-oriented chapters, the final one concentrates on four groups of drugs (peptides, biotechnological products, antibiotics and steroids) in order to demonstrate the use of the methods described earlier.

Handbook of Trace Analysis

Author : Irena Baranowska
Publisher : Springer
ISBN 13 : 3319196146
Total Pages : 458 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Handbook of Trace Analysis by : Irena Baranowska

Download or read book Handbook of Trace Analysis written by Irena Baranowska and published by Springer. This book was released on 2015-08-13 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is unique in its comprehensive coverage of the subject and focus on practical applications in diverse fields. It includes methods for sample preparation, the role of certified reference materials, calibration methods and statistical evaluation of the results. Problems concerning inorganic and bioinorganic speciation analysis, as well as special aspects such as trace analysis of noble metals, radionuclides and volatile organic compounds are also discussed. A significant part of the content presents applications of methods and procedures in medicine (metabolomics and therapeutic drug monitoring); pharmacy (the analysis of contaminants in drugs); studies of environmental samples; food samples and forensic analytics – essential examples that will also facilitate problem solving in related areas.

HPLC Method Development for Pharmaceuticals

Author : Satinder Ahuja
Publisher : Elsevier
ISBN 13 : 0080554199
Total Pages : 533 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis HPLC Method Development for Pharmaceuticals by : Satinder Ahuja

Download or read book HPLC Method Development for Pharmaceuticals written by Satinder Ahuja and published by Elsevier. This book was released on 2011-09-21 with total page 533 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Pharmaceutical Stress Testing

Author : Steven W. Baertschi
Publisher : CRC Press
ISBN 13 : 1439801800
Total Pages : 626 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Pharmaceutical Stress Testing by : Steven W. Baertschi

Download or read book Pharmaceutical Stress Testing written by Steven W. Baertschi and published by CRC Press. This book was released on 2016-04-19 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability

Characterization of Impurities and Degradants Using Mass Spectrometry

Author : Guodong Chen
Publisher : John Wiley & Sons
ISBN 13 : 0470922974
Total Pages : 402 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Characterization of Impurities and Degradants Using Mass Spectrometry by : Guodong Chen

Download or read book Characterization of Impurities and Degradants Using Mass Spectrometry written by Guodong Chen and published by John Wiley & Sons. This book was released on 2011-04-27 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including potential genotoxic impurities), and excipient related impurities in formulated products. Both general practitioners in pharmaceutical research and specialists in analytical chemistry field will benefit from this book that will detail step-by-step approaches and new strategies to solve challenging problems related to pharmaceutical research.

Handbook of Stability Testing in Pharmaceutical Development

Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
ISBN 13 : 0387856277
Total Pages : 389 pages
Book Rating : 4.3/5 (878 download)

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Book Synopsis Handbook of Stability Testing in Pharmaceutical Development by : Kim Huynh-Ba

Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

Pharmaceutical Excipients

Author : Otilia M. Y. Koo
Publisher : John Wiley & Sons
ISBN 13 : 1118992423
Total Pages : 369 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis Pharmaceutical Excipients by : Otilia M. Y. Koo

Download or read book Pharmaceutical Excipients written by Otilia M. Y. Koo and published by John Wiley & Sons. This book was released on 2016-10-03 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients

Handbook of Pharmaceutical Granulation Technology

Author : Dilip M. Parikh
Publisher : CRC Press
ISBN 13 : 1616310030
Total Pages : 678 pages
Book Rating : 4.6/5 (163 download)

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Book Synopsis Handbook of Pharmaceutical Granulation Technology by : Dilip M. Parikh

Download or read book Handbook of Pharmaceutical Granulation Technology written by Dilip M. Parikh and published by CRC Press. This book was released on 2016-04-19 with total page 678 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the re

Pharmaceutical Analysis for Small Molecules

Author : Behnam Davani
Publisher : John Wiley & Sons
ISBN 13 : 1119425018
Total Pages : 211 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Pharmaceutical Analysis for Small Molecules by : Behnam Davani

Download or read book Pharmaceutical Analysis for Small Molecules written by Behnam Davani and published by John Wiley & Sons. This book was released on 2017-08-01 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES

Author : Mr. Yash Srivastav
Publisher : JEC PUBLICATION
ISBN 13 : 9361756133
Total Pages : 218 pages
Book Rating : 4.3/5 (617 download)

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Book Synopsis MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES by : Mr. Yash Srivastav

Download or read book MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES written by Mr. Yash Srivastav and published by JEC PUBLICATION. This book was released on with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Welcome to "Modern Pharmaceutical Analytical Techniques." This book explores the forefront of analytical science in the pharmaceutical industry, offering a concise guide for students and professionals alike. Focused on precision and innovation, each chapter delves into cutting-edge techniques, from chromatography to mass spectrometry. The content reflects the collaborative effort of leading experts in the field. As we navigate this exploration, we hope that readers gain technical knowledge and a profound appreciation for the pivotal role analytical chemistry plays in ensuring the safety and efficacy of pharmaceuticals.

Insight on Genotoxicity

Author : Shiv Shankar Shukla
Publisher : CRC Press
ISBN 13 : 1000197255
Total Pages : 171 pages
Book Rating : 4.0/5 (1 download)

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Book Synopsis Insight on Genotoxicity by : Shiv Shankar Shukla

Download or read book Insight on Genotoxicity written by Shiv Shankar Shukla and published by CRC Press. This book was released on 2020-10-14 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic toxicology is considered to be an important assessment tool as there is genetic impact of artificial chemicals. Insight on Genotoxicity discusses testing, mechanism, prediction, and bioindicator of genotoxicity taking into consideration recent advances in nano-engineered particles. Corollary of DNA dent is also discussed in detail taking into consideration the impact of ICH guidelines on genotoxicity testing, which is important for drug discovery innovation and development. Perspective review of genotoxicity evaluation in phytopharmaceuticals has been mentioned along with the prevention of genotoxicity in brief viewpoint. Salient Features Presents methods, standard protocols, and guidelines for genotoxicity testing Examines the impact of ICH Guidelines on genetic toxicity testing which is a regulatory requirement for drug discovery and development Defines appropriate strategies about advances in in vivo genotoxicity testing which have been listed along with progress and prospects Discusses advancement in the high-throughput approaches for genotoxicity testing Details computational prediction of genotoxicity with consideration of mutagenicity, chromosomal damage caused and strategies for computational prediction in drug development

Polymorphism in Pharmaceutical Solids

Author : Harry G. Brittain
Publisher : CRC Press
ISBN 13 : 1420073222
Total Pages : 656 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Polymorphism in Pharmaceutical Solids by : Harry G. Brittain

Download or read book Polymorphism in Pharmaceutical Solids written by Harry G. Brittain and published by CRC Press. This book was released on 2018-11-12 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: Using clear and practical examples, Polymorphism of Pharmaceutical Solids, Second Edition presents a comprehensive examination of polymorphic behavior in pharmaceutical development that is ideal for pharmaceutical development scientists and graduate students in pharmaceutical science. This edition focuses on pharmaceutical aspects of polymorphism a