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Measuring Elemental Impurities In Pharmaceuticals

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Measuring Elemental Impurities In Pharmaceuticals

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Author : Robert Thomas
language : en
Publisher: CRC Press
Release Date : 2018-01-29

Measuring Elemental Impurities In Pharmaceuticals written by Robert Thomas and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-29 with Medical categories.

Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters , , and , together with Q3D, Step 4 guidelines for elemental impurities, drafted by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), a consortium of global pharmaceutical associations, including the European Pharmacopeia (Ph.Eur.), the Japanese Pharmacopeia (JP) and the USP. This book provides a complete guide to the analytical methodology, instrumental techniques and sample preparation procedures used for measuring elemental impurities in pharmaceutical and nutraceutical materials. It offers readers the tools to better understand plasma spectrochemistry to optimize detection capability for the full suite of elemental PDE (Permitted Daily Exposure) levels in the various drug delivery categories. Other relevant information covered in the book includes: The complete guide to measuring elemental impurities in pharmaceutical and nutraceutical materials. Covers heavy metals testing in the pharmaceutical industry from an historical perspective. Gives an overview of current USP Chapters and and ICH Q3D Step 4 Guidelines. Explains the purpose of validation protocols used in Chapter , including how J-values are calculated Describes fundamental principles and practical capabilities of ICP-MS and ICP-OES. Offers guidelines about the optimum strategy for risk assessment Provides tips on how best to prepare and present your data for regulatory inspection. An indispensable resource, the fundamental principles and practical benefits of ICP-OES and ICP-MS are covered in a reader-friendly format that a novice, who is carrying out elemental impurities testing in the pharmaceutical and nutraceutical communities, will find easy to understand.

Measuring Heavy Metal Contaminants In Cannabis And Hemp

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Author : Robert J. Thomas
language : en
Publisher: CRC Press
Release Date : 2020-09-30

Measuring Heavy Metal Contaminants In Cannabis And Hemp written by Robert J. Thomas and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-09-30 with Science categories.

The surge of interest in cannabis-based medicinal products has put an extremely high demand on testing capabilities, particularly for contaminants such as heavy metals, which are naturally taken up through the roots of the plants from the soil, growing medium, and fertilizers but can also be negatively impacted by the grinding equipment and extraction/distillation process. Unfortunately, many state regulators do not have the necessary experience and background to fully understand all the safety and toxicological issues regarding the cultivation and production of cannabis and hemp products on the market today. Measuring Heavy Metal Contaminants in Cannabis and Hemp offers a comprehensive guide to the entire cannabis industry for measuring elemental contaminants in cannabis and hemp. For testing labs, it describes fundamental principles and practical capabilities of ICP-MS and other AS techniques for measuring heavy metals in cannabis. For state regulators, it compares maximum contaminant limits of heavy metals with those for federally regulated pharmaceutical materials. For cultivators and processors, it helps them to better understand the many sources of heavy metals in cannabis. And for consumers of medical cannabis, it highlights the importance of choosing cannabis products that are safe to use. Other key topics include: The role of other analytical techniques for the comprehensive testing of cannabis products Tips to optimize analytical procedures to ensure the highest quality data Guidance on how to characterize elemental contaminants in vaping liquids and aerosols Suggestions on how to reduce errors using plasma spectrochemistry The role of certified reference materials to validate standard methods Easy-to-read sections on instrumental hardware components, calibration and measurement protocols, typical interferences, routine maintenance, and troubleshooting procedures Written with the cannabis testing community in mind, this book is also an invaluable resource for growers, cultivators, processors, testers, regulators, and even consumers who are interested in learning more about the potential dangers of heavy metal contaminants in cannabis and hemp.

Measuring Elemental Impurities In Pharmaceuticals

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Author : Robert Thomas
language : en
Publisher: CRC Press
Release Date : 2018-01-29

Practical Guide To Icp Ms

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Author : Robert Thomas
language : en
Publisher: CRC Press
Release Date : 2003-12-11

Practical Guide To Icp Ms written by Robert Thomas and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-12-11 with Science categories.

Written by a field insider with more than 20 years of experience in the development and application of atomic spectroscopy instrumentation, the Practical Guide to ICP-MS offers key concepts and guidelines in a reader-friendly format that is superb for those with limited knowledge of the technique. This reference discusses the fundamental principles, analytical advantages, practical capabilities, and overall benefits of ICP-MS. It presents the most important selection criteria when evaluating commercial ICP-MS equipment and the most common application areas of ICP-MS such as the environmental, semiconductor, geochemical, clinical, nuclear, food, metallurgical, and petrochemical industries.

Genotoxic Impurities

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Author : Andrew Teasdale
language : en
Publisher: John Wiley & Sons
Release Date : 2011-03-29

Genotoxic Impurities written by Andrew Teasdale and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-03-29 with Medical categories.

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 And Quality Control

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Author : Paulo Pereira (mikrobiolog.)
language : en
Publisher:
Release Date : 2019-04-10

Quality Management And Quality Control written by Paulo Pereira (mikrobiolog.) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-10 with Management. Industrial management categories.

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.

Trace Elemental Analysis Of Metals

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Author : Thomas R. Dulski
language : en
Publisher: CRC Press
Release Date : 1999-06-08

Trace Elemental Analysis Of Metals written by Thomas R. Dulski and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-06-08 with Technology & Engineering categories.

This work details minor, trace and ultratrace methods; addresses the essential stages that precede measurement; and highlights the measurement systems most likey to be used by the pragmatic analyst. It features key material on inclusion and phase isolation. The book is designed to provide useful maps and signposts for metals analysts who must verify that stringent trace level compositional specifications have been met.

Specification Of Drug Substances And Products

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Author : Christopher M. Riley
language : en
Publisher: Elsevier
Release Date : 2020-07-23

Specification Of Drug Substances And Products written by Christopher M. Riley and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-07-23 with Science categories.

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

Mutagenic Impurities

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Author : Andrew Teasdale
language : en
Publisher: John Wiley & Sons
Release Date : 2022-02-15

Mutagenic Impurities written by Andrew Teasdale and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-02-15 with Medical categories.

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.

Development And Validation Of Analytical Methods

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Author : Christopher M. Riley
language : en
Publisher: Elsevier
Release Date : 1996-05-29

Development And Validation Of Analytical Methods written by Christopher M. Riley and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996-05-29 with Science categories.

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.

Measuring Elemental Impurities In Pharmaceuticals

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