راهنمای جداسازی و شناسایی ناخالصی‌ها در داروسازی (جلد ۵) (علم و فناوری جداسازی، جلد ۵)

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. Content: Preface Pages xi-xiii Satinder Ahuja Contributors Pages xv-xvi Overview: Isolation and characterization of impurities Original Research Article Pages 1-25 Satinder Ahuja Review of regulatory guidance on impurities Original Research Article Pages 27-37 Radhika rajagopalan Polymorphic and solvatomorphic impurities Original Research Article Pages 39-73 Harry G. Brittain, Ales Medek Impurities in drug products Original Research Article Pages 75-88 Kenneth C. Waterman, Roger C. Adami, Jin Yang Hong Strategies for investigation and control of process- and degradation-related impurities Original Research Article Pages 89-117 Bernard A. Olsen, Steven W. Baertschi Reference standards Original Research Article Pages 119-143 Paul A. Culbert, Bruce D. Johnson Sample selection for analytical method development Original Research Article Pages 145-164 Hugh J. Clarke, Kenneth J. Norris Sample preparation methods for the analysis of pharmaceutical materials Original Research Article Pages 165-201 David T. Rossi, Kenneth G. Miller Isolation methods I: Thin-layer chromatography Original Research Article Pages 203-230 Pamela M. Gorman, Hong Jiang Isolation methods II: Column chromatography Original Research Article Pages 231-248 Mark Guinn, Ronald Bates, Benjamin Hritzko, Teri Shanklin, Glenn Wilcox, Sam Guhan Mass spectral characterization Original Research Article Pages 249-299 David J. Burinsky, Feng Wang NMR characterization of impurities Original Research Article Pages 301-339 Linda L. Lohr, Andrew J. Jensen, Thomas R. Sharp Hyphenated characterization techniques Original Research Article Pages 341-359 Thomas N. Feinberg Solving impurity/degradation problems: Case studies Original Research Article Pages 361-400 Karen M. Alsante, Todd D. Hatajik, Linda L. Lohr, Dinos Santafianos, Thomas R. Sharp Index Pages 401-414 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. Let us first briefly review what constitutes an impurity in a drug substance (a new chemical entity of therapeutic interest) or drug product (a drug substance formulated into a suitable product for administration to patients) to enable us to better understand the need to isolate and characterize impurities.