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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.
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.
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.
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.
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.
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.
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.
The first book devoted exclusively to a highly popular, relatively new detection technique Charged Aerosol Detection for Liquid Chromatography and Related Separation Techniques presents a comprehensive review of CAD theory, describes its advantages and limitations, and offers extremely well-informed recommendations for its practical use. Using numerous real-world examples based on contributors’ professional experiences, it provides priceless insights into the actual and potential applications of CAD across a wide range of industries. Charged aerosol detection can be combined with a variety of separation techniques and in numerous configurations. While it has been widely adapted for an array of industrial and research applications with great success, it is still a relatively new technique, and its fundamental performance characteristics are not yet fully understood. This book is intended as a tool for scientists seeking to identify the most effective and efficient uses of charged aerosol detection for a given application. Moving naturally from basic to advanced topics, the author relates fundamental principles, practical uses, and applications across a range of industrial settings, including pharmaceuticals, petrochemicals, biotech, and more. Offers timely, authoritative coverage of the theory, experimental techniques, and end-user applications of charged aerosol detection Includes contributions from experts from various fields of applications who explore CAD’s advantages over traditional HPLC techniques, as well its limitations Provides a current theoretical and practical understanding of CAD, derived from authorities on aerosol technology and separation sciences Features numerous real-world examples that help relate fundamental properties and general operational variables of CAD to its performance in a variety of conditions Charged Aerosol Detection for Liquid Chromatography and Related Separation Techniques is a valuable resource for scientists who use chromatographic techniques in academic research and across an array of industrial settings, including the biopharmaceutical, biotechnology, biofuel, chemical, environmental, and food and beverage industries, among others.
This textbook is the first to present a systematic introduction to chemical analysis of pharmaceutical raw materials, finished pharmaceutical products, and of drugs in biological fluids, which are carried out in pharmaceutical laboratories worldwide. In addition, this textbook teaches the fundamentals of all the major analytical techniques used in the pharmaceutical laboratory, and teaches the international pharmacopoeias and guidelines of importance for the field. It is primarily intended for the pharmacy student, to teach the requirements in “analytical chemistry” for the 5 years pharmacy curriculum, but the textbook is also intended for analytical chemists moving into the field of pharmaceutical analysis. Addresses the basic concepts, then establishes the foundations for the common analytical methods that are currently used in the quantitative and qualitative chemical analysis of pharmaceutical drugs Provides an understanding of common analytical techniques used in all areas of pharmaceutical development Suitable for a foundation course in chemical and pharmaceutical sciences Aimed at undergraduate students of degrees in Pharmaceutical Science/Chemistry Analytical Science/Chemistry, Forensic analysis Includes many illustrative examples
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.