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Development Of An Analytical Method For Active Pharmaceutical Ingredient Assay By Near Infrared Spectroscopy
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Book Synopsis Development of an analytical method for active pharmaceutical ingredient assay by near infrared spectroscopy by : Hélène Comyn
Download or read book Development of an analytical method for active pharmaceutical ingredient assay by near infrared spectroscopy written by Hélène Comyn and published by . This book was released on 2020 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy by : Emil W. Ciurczak
Download or read book Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy written by Emil W. Ciurczak and published by CRC Press. This book was released on 2002-02-08 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy by : Emil W. Ciurczak
Download or read book Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy written by Emil W. Ciurczak and published by CRC Press. This book was released on 2014-12-15 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Analytical Method Development and Validation by : Michael E. Swartz
Download or read book Analytical Method Development and Validation written by Michael E. Swartz and published by CRC Press. This book was released on 1997-05-16 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Moisture Determination in an Active Pharmaceutical Ingredient (API) by Near Infrared Spectroscopy by : Orlando Rodríguez Ramos
Download or read book Moisture Determination in an Active Pharmaceutical Ingredient (API) by Near Infrared Spectroscopy written by Orlando Rodríguez Ramos and published by . This book was released on 2000 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Investigation of Various Analytical Methods for the Identification and Quantification of Active Pharmaceutical Ingredients by : Kaho Kwok
Download or read book Investigation of Various Analytical Methods for the Identification and Quantification of Active Pharmaceutical Ingredients written by Kaho Kwok and published by . This book was released on 2007 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Evaluation of the Use of Near-infrared Spectroscopy for the Analysis of Pharmaceutical and Adhesive Preparations by : Dolores Niland
Download or read book Evaluation of the Use of Near-infrared Spectroscopy for the Analysis of Pharmaceutical and Adhesive Preparations written by Dolores Niland and published by . This book was released on 1999 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Pharmaceutical and Medical Applications of Near-infrared Spectroscopy by :
Download or read book Pharmaceutical and Medical Applications of Near-infrared Spectroscopy written by and published by . This book was released on 2010 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. Blend uniformity analysis Mixing Discussion of reported work Sampling and data handling Segregation, Demixing, and Particle Size Granulation, Drying, and Coating Monitoring Granulation and Drying Coating and Pelletization Pharmaceutical assays Qualitative analysis Quantitative analysis Determination of actives in tablets and capsules Considerations for intact dosage form analysis Validation issues International conference on harmonization Historical perspective Medical applications Blood glucose Blood oxygenation Tissue Major organs Blood chemistry Fetuses and newborns Cancer and precancer Photon migration in tissues Review articles Index
Book Synopsis Residual Solvent Determination in an Active Pharmaceutical Ingredient (API) by Near Infrared Spectroscopy by : Raúl Enrique Gómez Pérez
Download or read book Residual Solvent Determination in an Active Pharmaceutical Ingredient (API) by Near Infrared Spectroscopy written by Raúl Enrique Gómez Pérez and published by . This book was released on 2000 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Near-infrared Spectroscopic Assay Transfer for Active Pharmaceutical Ingredients in Intact Tablets by :
Download or read book Near-infrared Spectroscopic Assay Transfer for Active Pharmaceutical Ingredients in Intact Tablets written by and published by . This book was released on 2005 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Development of a Hybrid Analytical Technique Using Near Infrared Spectroscopy and Thin Layer Chromatography by : Jaclyn Ann Robustelli
Download or read book Development of a Hybrid Analytical Technique Using Near Infrared Spectroscopy and Thin Layer Chromatography written by Jaclyn Ann Robustelli and published by . This book was released on 2014 with total page 42 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Development of Quantitative Assays for the Actives in Intact Pharmaceutical Capsules Using Near-infrared Spectroscopy by :
Download or read book Development of Quantitative Assays for the Actives in Intact Pharmaceutical Capsules Using Near-infrared Spectroscopy written by and published by . This book was released on 2007 with total page 630 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Developments in Analytical Methods in Pharmaceutical, Biomedical, and Forensic Sciences by : Giuseppe Piemonte
Download or read book Developments in Analytical Methods in Pharmaceutical, Biomedical, and Forensic Sciences written by Giuseppe Piemonte and published by . This book was released on 1987 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Development of Quantitiative Assays for the Actives in Intact Pharmaceutical Capsules Using Near-infrared Spectroscopy by :
Download or read book Development of Quantitiative Assays for the Actives in Intact Pharmaceutical Capsules Using Near-infrared Spectroscopy written by and published by . This book was released on 2007 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Spectroscopic and Chemometric Techniques for Pharmaceutical Applications by : Gerard G. Dumancas
Download or read book Spectroscopic and Chemometric Techniques for Pharmaceutical Applications written by Gerard G. Dumancas and published by American Chemical Society. This book was released on 2023-05-15 with total page 143 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spectroscopic and chemometric methods have become routinely applied tools in pharmaceutical industries because they reduce the analysis time and minimize the use of chemicals. The contents of this digital primer are to help newcomers in the field by providing basic content information about various spectroscopic and chemometric tools used in pharmaceutical analysis.
Book Synopsis Low-level Pharmaceutical Analysis of Drugs and Impurities by Near-infrared Spectroscopy by : Mark Richard Morton
Download or read book Low-level Pharmaceutical Analysis of Drugs and Impurities by Near-infrared Spectroscopy written by Mark Richard Morton and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Process Analytical Technology by : Katherine A. Bakeev
Download or read book Process Analytical Technology written by Katherine A. Bakeev and published by John Wiley & Sons. This book was released on 2010-04-01 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Analytical Technology explores the concepts of PAT and its application in the chemical and pharmaceutical industry from the point of view of the analytical chemist. In this new edition all of the original chapters have been updated and revised, and new chapters covering the important topics of sampling, NMR, fluorescence, and acoustic chemometrics have been added. Coverage includes: Implementation of Process Analytical Technologies UV-Visible Spectroscopy for On-line Analysis Infrared Spectroscopy for Process Analytical Applications Process Raman Spectroscopy Process NMR Spectrscopy: Technology and On-line Applications Fluorescent Sensing and Process Analytical Applications Chemometrics in Process Analytical Technology (PAT) On-Line PAT Applications of Spectroscopy in the Pharmaceutical Industry Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing NIR Chemical Imaging This volume is an important starting point for anyone wanting to implement PAT and is intended not only to assist a newcomer to the field but also to provide up-to-date information for those who practice process analytical chemistry and PAT. It is relevant for chemists, chemical and process engineers, and analytical chemists working on process development, scale-up and production in the pharmaceutical, fine and specialty chemicals industries, as well as for academic chemistry, chemical engineering, chemometrics and pharmaceutical science research groups focussing on PAT. Review from the First Edition “The book provides an excellent first port of call for anyone seeking material and discussions to understand the area better. It deserves to be found in every library that serves those who are active in the field of Process Analytical Technology.”—Current Engineering Practice