Impurities Guideline For Residual Solvents
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Impurities Guideline For Residual Solvents
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Author : Canada. Therapeutic Products Programme
language : en
Publisher:
Release Date : 1999
Impurities Guideline For Residual Solvents written by Canada. Therapeutic Products Programme and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999 with Contamination (Technology) categories.
Ich Quality Guidelines
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Author : Andrew Teasdale
language : en
Publisher: John Wiley & Sons
Release Date : 2017-10-09
Ich Quality Guidelines 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 2017-10-09 with Medical categories.
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Guidance For Industry
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Author :
language : en
Publisher:
Release Date : 1997
Guidance For Industry written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with categories.
Guidance For Industry
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Author :
language : en
Publisher:
Release Date : 1999
Guidance For Industry written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999 with categories.
Static Headspace Gas Chromatography
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Author : Bruno Kolb
language : en
Publisher: John Wiley & Sons
Release Date : 2006-06-23
Static Headspace Gas Chromatography written by Bruno Kolb 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 2006-06-23 with Science categories.
The only reference to provide both current and thorough coverage of this important analytical technique Static headspace-gas chromatography (HS-GC) is an indispensable technique for analyzing volatile organic compounds, enabling the analyst to assay a variety of sample matrices while avoiding the costly and time-consuming preparation involved with traditional GC. Static Headspace-Gas Chromatography: Theory and Practice has long been the only reference to provide in-depth coverage of this method of analysis. The Second Edition has been thoroughly updated to reflect the most recent developments and practices, and also includes coverage of solid-phase microextraction (SPME) and the purge-and-trap technique. Chapters cover: * Principles of static and dynamic headspace analysis, including the evolution of HS-GC methods and regulatory methods using static HS-GC * Basic theory of headspace analysis-physicochemical relationships, sensitivity, and the principles of multiple headspace extraction * HS-GC techniques-vials, cleaning, caps, sample volume, enrichment, and cryogenic techniques * Sample handling * Cryogenic HS-GC * Method development in HS-GC * Nonequilibrium static headspace analysis * Determination of physicochemical functions such as vapor pressures, activity coefficients, and more Comprehensive and focused, Static Headspace-Gas Chromatography, Second Edition provides an excellent resource to help the reader achieve optimal chromatographic results. Practical examples with original data help readers to master determinations in a wide variety of areas, such as forensic, environmental, pharmaceutical, and industrial applications.
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.
Green Extraction Of Natural Products
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Author : Farid Chemat
language : en
Publisher: John Wiley & Sons
Release Date : 2016-03-11
Green Extraction Of Natural Products written by Farid Chemat 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 2016-03-11 with Science categories.
Extraction processes are essential steps in numerous industrial applications from perfume over pharmaceutical to fine chemical industry. Nowadays, there are three key aspects in industrial extraction processes: economy and quality, as well as environmental considerations. This book presents a complete picture of current knowledge on green extraction in terms of innovative processes, original methods, alternative solvents and safe products, and provides the necessary theoretical background as well as industrial application examples and environmental impacts. Each chapter is written by experts in the field and the strong focus on green chemistry throughout the book makes this book a unique reference source. This book is intended to be a first step towards a future cooperation in a new extraction of natural products, built to improve both fundamental and green parameters of the techniques and to increase the amount of extracts obtained from renewable resources with a minimum consumption of energy and solvents, and the maximum safety for operators and the environment.
Pharmaceutical Analysis For Small Molecules
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Author : Behnam Davani
language : en
Publisher: John Wiley & Sons
Release Date : 2017-08-01
Pharmaceutical Analysis For Small Molecules written by Behnam Davani 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 2017-08-01 with Science categories.
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.
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.