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Les méthodes spectroscopiques sont devenues des techniques incontournables dans le milieu de la Chimie, avec un immense champ de possibilités. Parmi celles-ci, la Spectroscopie Proche Infrarouge (NIRS) est une technique analytique en plein essor dans l'industrie pharmaceutique. L'objectif du travail qui a supporté cette thèse était de développer une méthode d'analyse par spectroscopie proche infrarouge pour le dosage de principe actif dans un produit fini, à des fins de libération de lots. Cette nouvelle méthode, plus rapide, et plus économique, présente une alternative à la méthode de dosage actuelle par HPLC. Ce projet inclut le développement du modèle de calibration, la comparaison du modèle obtenu avec la méthode de référence, et la validation de la méthode selon les réglementations internes et internationales relatives aux méthodes analytiques. Cette thèse présente l'étude de faisabilité menée lors de la construction du modèle de calibration, ainsi que la stratégie de validation de la méthode et ses résultats. Une méthode analytique satisfaisante a été développée, pour deux formes différentes du produit : sous forme granules ou poudres (résultant du broyage des granules). L'analyse de données multivariées a été utilisée pour la construction du modèle. Le modèle a une précision (RMSECV) de 0.6% de la dose nominale, et a été démontré au moins équivalent à la méthode HPLC, si ce n'est meilleur en termes de précision.
This book discusses the theory, instrumentation, validation, and implementation of near-infrared spectroscopy for pharmaceutical and medical applications. It showcases a diverse range of contemporary methods for the production, screening, and analysis of new drug products and pharmaceuticals. Presents current approaches in near-infrared spectroscopy (NIR) to monitor and control multiple phases of the drug manufacturing process.
Since the completion of the first edition of this book, major developments have occurred in the pharmaceutical industry that have shaped the field of near-infrared (NIR) spectroscopy. A new initiative from the U.S. Food and Drug Administration (FDA) to modernize regulations of pharmaceutical manufacturing and drug quality has helped position NIR sp
Rapid, inexpensive, and easy-to-deploy, near-infrared (NIR) spectroscopy can be used to analyze samples of virtually any composition, origin, and condition. The Handbook of Near Infrared Analysis, Fourth Edition, explores the factors necessary to perform accurate and time- and cost-effective analyses across a growing spectrum of disciplines. This updated and expanded edition incorporates the latest advances in instrumentation, computerization, chemometrics applied to NIR spectroscopy, and method development in NIR spectroscopy, and underscores current trends in sample preparation, calibration transfer, process control, data analysis, instrument performance testing, and commercial NIR instrumentation. This work offers readers an unparalleled combination of theoretical foundations, cutting-edge applications, and practical experience. Additional features include the following: Explains how to perform accurate as well as time- and cost-effective analyses. Reviews software-enabled chemometric methods and other trends in data analysis. Highlights novel applications in pharmaceuticals, polymers, plastics, petrochemicals, textiles, foods and beverages, baked products, agricultural products, biomedicine, nutraceuticals, and counterfeit detection. Underscores current trends in sample preparation, calibration transfer, process control, data analysis, and multiple aspects of commercial NIR instrumentation. Offering the most complete single-source guide of its kind, the Handbook of Near Infrared Analysis, Fourth Edition, continues to offer practicing chemists and spectroscopists an unparalleled combination of theoretical foundations, cutting-edge applications, and detailed practical experience provided firsthand by more than 50 experts in the field.
An introductory text, written with the needs of the student in mind, which explains all the most important techniques used in the analysis of pharmaceuticals - a key procedure in ensuring the quality of drugs . The text is enhanced throughout with keypoints and self-assessment boxes, to aid student learning. Features Includes worked calculations to demonstrate mathematics in use for pharmaceutical analysis. Focuses on key points rather than a large number of facts to help readers really understand the field as well as pass exams. Includes self-assessment, focussing on simple arithmetical calculation results from analytical data. Additional section on basic calculations in pharmaceutical analysis More detail on the capillary electrophoresis of proteins A discussion of some of the new types of HPLC column and on solvent selectivity in HPLC Additional material inserted on the control of the quality of analytical methods, mass spectrometry and high pressure liquid chromatography Additional self-assessment exercises
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
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 analyses, 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.The mathematics involved is notoriously difficult, but this much-praised and well established textbook, now revised and updated for its fifth edition, guides a student through the complexities with clear writing and the author's expertise from many years' teaching pharmacy students. Worked calculation examples and self-assessment test questions aid continuous learning reinforcement throughout Frequent use of figures and diagrams clarify points made in the text Practical examples are used to show the application of techniques Key points boxes summarise the need to know information for each topic Focuses on the most relevant and frequently used techniques within the field
The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.
This book seeks to introduce the reader to current methodologies in analytical calibration and validation. This collection of contributed research articles and reviews addresses current developments in the calibration of analytical methods and techniques and their subsequent validation. Section 1, "Introduction," contains the Introductory Chapter, a broad overview of analytical calibration and validation, and a brief synopsis of the following chapters. Section 2 "Calibration Approaches" presents five chapters covering calibration schemes for some modern analytical methods and techniques. The last chapter in this section provides a segue into Section 3, "Validation Approaches," which contains two chapters on validation procedures and parameters. This book is a valuable source of scientific information for anyone interested in analytical calibration and validation.