Identification And Determination Of Impurities In Drugs

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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.

Quality Management and Quality Control

Author : Paulo Pereira
Publisher : Intechopen
ISBN 13 : 1789238773
Total Pages : 146 pages
Book Rating : 4.7/5 (892 download)

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Book Synopsis Quality Management and Quality Control by : Paulo Pereira

Download or read book Quality Management and Quality Control written by Paulo Pereira and published by Intechopen. This book was released on 2019 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality management (QM) practices are the basis for the successful implementation and maintenance of any QM system. Quality control (QC) is identified as a QM component. Therefore, QM effectiveness is dependent on the QC strategy. QC practice is more or less complex depending on the type of production. The book is focused on new trends and developments in QM and QC in several types of industries from a worldwide perspective. Its content has been organized into two sections and seven chapters written by well-recognized researchers worldwide. Several approaches are debated based on sample traceability, analytical method validation, required parameters, class of exponential regression-type estimators of the population means, determination of impurities, viewpoints, and case studies.

Countering the Problem of Falsified and Substandard Drugs

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309269393
Total Pages : 377 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Countering the Problem of Falsified and Substandard Drugs by : Institute of Medicine

Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Genotoxic Impurities

Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 0470934751
Total Pages : 455 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Genotoxic Impurities by : Andrew Teasdale

Download or read book Genotoxic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2011-03-29 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

Author : Satinder Ahuja
Publisher : Elsevier
ISBN 13 : 008050776X
Total Pages : 432 pages
Book Rating : 4.0/5 (85 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 Elsevier. This book was released on 2003-06-26 with total page 432 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.

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.

Method Validation in Pharmaceutical Analysis

Author : Joachim Ermer
Publisher : John Wiley & Sons
ISBN 13 : 3527604472
Total Pages : 418 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Method Validation in Pharmaceutical Analysis by : Joachim Ermer

Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

Pharmaceutical Chemistry of Antihypertensive Agents

Author : Gyorgy Szasz
Publisher : CRC Press
ISBN 13 : 9780849347245
Total Pages : 288 pages
Book Rating : 4.3/5 (472 download)

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Book Synopsis Pharmaceutical Chemistry of Antihypertensive Agents by : Gyorgy Szasz

Download or read book Pharmaceutical Chemistry of Antihypertensive Agents written by Gyorgy Szasz and published by CRC Press. This book was released on 1990-12-19 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Chemistry of Antihypertensive Agents, provides the only comprehensive treatment of anti-hypertensive properties (e.g., structure-activity relationship, analytics, and metabolism) of pharmaceutical chemicals. The topics discussed include diuretics, renin inhibitors, angiotensin-converting enzyme inhibitors, a-blocking agents, b-adrenergic antagonists, and vasodilators. Data is supported by more than 1400 references and 300 chemical structures. This book is essential reading for physicians and pharmaceutical researchers, as well as pharmaceutical chemistry students.

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.

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.

Pharmaceutical Analysis E-Book

Author : David G. Watson
Publisher : Elsevier Health Sciences
ISBN 13 : 0702069884
Total Pages : 598 pages
Book Rating : 4.7/5 (2 download)

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Book Synopsis Pharmaceutical Analysis E-Book by : David G. Watson

Download or read book Pharmaceutical Analysis E-Book written by David G. Watson and published by Elsevier Health Sciences. This book was released on 2015-12-24 with total page 598 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical analysis determines the purity, concentration, active compounds, shelf life, rate of absorption in the body, identity, stability, rate of release etc. of a drug. Testing a pharmaceutical product involves a variety of chemical, physical and microbiological analyses. It is reckoned that over £10 billion is spent annually in the UK alone on pharmaceutical analysis, and the analytical processes described in this book are used in industries as diverse as food, beverages, cosmetics, detergents, metals, paints, water, agrochemicals, biotechnological products and pharmaceuticals. This is the key textbook in pharmaceutical analysis, now revised and updated for its fourth edition. Worked calculation examples Self-assessment Additional problems (self tests) Practical boxes Key points boxes New chapter on electrochemical biosensors. New chapter on the quality control of biotechnologically produced drugs. Extended chapter on molecular emission spectroscopy. Now comes with an e-book on StudentConsult. Self-assessment is interactive in the accompanying online e-book. 65 online animations show concepts such as ionization partitioning of drug molecules etc. ~

Mutagenic Impurities

Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 1119551218
Total Pages : 548 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Mutagenic Impurities by : Andrew Teasdale

Download or read book Mutagenic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2022-02-15 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.

Analysis of Pharmaceuticals by Capillary Electrophoresis

Author : Kevin D. Altria
Publisher : Springer Science & Business Media
ISBN 13 : 3322850110
Total Pages : 300 pages
Book Rating : 4.3/5 (228 download)

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Book Synopsis Analysis of Pharmaceuticals by Capillary Electrophoresis by : Kevin D. Altria

Download or read book Analysis of Pharmaceuticals by Capillary Electrophoresis written by Kevin D. Altria and published by Springer Science & Business Media. This book was released on 2013-04-17 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dieser erste Titel einer ganzen Serie von anwendungsbezogenen Handbüchern zur Kapillarelektrophorese beschäftigt sich mit der Analytik von pharmazeutischen Substanzen. Dabei werden verschiedene Techniken praxisnah erläutert. Jeder, der im Labor - ob wissenschaftlich oder praxisnah - mit der Analyse von oft chiralen Pharmazeutika konfrontiert ist, wird viele Hinweise und Tips für seine Arbeit finden.USP: Einzige Monographie zur Analyse von Pharmazeutika mit CE This book describes the current state of the art for the analysis of pharmaceuticals by capillary electrophoresis and contains several hundred references to specific applications and methods. The main purpose of the book is to present the application possibilities of CE an therefore tabulated application data are provided. Chapters of the book are devoted to providing details of individual application areas such as chiral analysis, determination of drug related impurities, determination of drug counter-ions, drug residue monitoring and main component assay. An introductory chapter provides theoretical background to CE an related techniques. A chapter is dedicated to capillary electrochromatography which highlights the importance this technique currently possesses. Successful regulatory acceptance of CE methods is also described. A comprehensive chapter covers method validation aspects. Other chapters include discrete areas such as the use of non-aqueous solvents, forensic applications of CE, the application of experimental designs, determination of drugs in biofluids, and the analysis of vitamins by CE.

Steroid Analysis

Author : Hugh L. J. Makin
Publisher : Springer Science & Business Media
ISBN 13 : 1402097751
Total Pages : 1240 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Steroid Analysis by : Hugh L. J. Makin

Download or read book Steroid Analysis written by Hugh L. J. Makin and published by Springer Science & Business Media. This book was released on 2010-06-04 with total page 1240 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this handbook concentrates on the analysis of steroids in biological fluids. It offers analysis of low levels of steroid analytes in biological fluids. This new edition also provides an extra chapter on pharmaceutical aspects of steroid analysis. Coverage details spectroscopic and other methods, including UV and IR absorption spectroscopy, NMR spectroscopy, mass spectrometry, X-ray diffraction, chromatography and immunoassay of steroids.

Guideline for Submitting Samples and Analytical Data for Methods Validation

Author :
Publisher :
ISBN 13 :
Total Pages : 28 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Guideline for Submitting Samples and Analytical Data for Methods Validation by :

Download or read book Guideline for Submitting Samples and Analytical Data for Methods Validation written by and published by . This book was released on 1987 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Encyclopedia of Analytical Science

Author :
Publisher : Elsevier
ISBN 13 : 008101984X
Total Pages : 5142 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Encyclopedia of Analytical Science by :

Download or read book Encyclopedia of Analytical Science written by and published by Elsevier. This book was released on 2019-04-02 with total page 5142 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third edition of the Encyclopedia of Analytical Science, Ten Volume Set is a definitive collection of articles covering the latest technologies in application areas such as medicine, environmental science, food science and geology. Meticulously organized, clearly written and fully interdisciplinary, the Encyclopedia of Analytical Science, Ten Volume Set provides foundational knowledge across the scope of modern analytical chemistry, linking fundamental topics with the latest methodologies. Articles will cover three broad areas: analytical techniques (e.g., mass spectrometry, liquid chromatography, atomic spectrometry); areas of application (e.g., forensic, environmental and clinical); and analytes (e.g., arsenic, nucleic acids and polycyclic aromatic hydrocarbons), providing a one-stop resource for analytical scientists. Offers readers a one-stop resource with access to information across the entire scope of modern analytical science Presents articles split into three broad areas: analytical techniques, areas of application and and analytes, creating an ideal resource for students, researchers and professionals Provides concise and accessible information that is ideal for non-specialists and readers from undergraduate levels and higher

Development and Validation of Analytical Methods

Author : Christopher M. Riley
Publisher : Elsevier
ISBN 13 : 0080530354
Total Pages : 363 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis Development and Validation of Analytical Methods by : Christopher M. Riley

Download or read book Development and Validation of Analytical Methods written by Christopher M. Riley and published by Elsevier. This book was released on 1996-05-29 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.