Investigation Of Various Analytical Methods For The Identification And Quantification Of Active Pharmaceutical Ingredients

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Analytical Techniques in the Pharmaceutical Sciences

Author : Anette Müllertz
Publisher : Springer
ISBN 13 : 1493940295
Total Pages : 829 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Analytical Techniques in the Pharmaceutical Sciences by : Anette Müllertz

Download or read book Analytical Techniques in the Pharmaceutical Sciences written by Anette Müllertz and published by Springer. This book was released on 2016-08-30 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Guideline for Submitting Samples and Analytical Data for Methods Validation

Author :
Publisher :
ISBN 13 :
Total Pages : 28 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Guideline for Submitting Samples and Analytical Data for Methods Validation by :

Download or read book Guideline for Submitting Samples and Analytical Data for Methods Validation written by and published by . This book was released on 1987 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Practical HPLC Method Development

Author : Lloyd R. Snyder
Publisher : John Wiley & Sons
ISBN 13 : 1118591518
Total Pages : 665 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Practical HPLC Method Development by : Lloyd R. Snyder

Download or read book Practical HPLC Method Development written by Lloyd R. Snyder and published by John Wiley & Sons. This book was released on 2012-12-03 with total page 665 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revision brings the reader completely up to date on the evolving methods associated with increasingly more complex sample types analyzed using high-performance liquid chromatography, or HPLC. The book also incorporates updated discussions of many of the fundamental components of HPLC systems and practical issues associated with the use of this analytical method. This edition includes new or expanded treatments of sample preparation, computer assisted method development, as well as biochemical samples, and chiral separations.

Countering the Problem of Falsified and Substandard Drugs

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309269393
Total Pages : 377 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Countering the Problem of Falsified and Substandard Drugs by : Institute of Medicine

Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Genotoxic Impurities

Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 0470934751
Total Pages : 455 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Genotoxic Impurities by : Andrew Teasdale

Download or read book Genotoxic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2011-03-29 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Advances in Analytical Techniques for Forensic Investigation

Author : Priyanka Chhabra
Publisher : John Wiley & Sons
ISBN 13 : 1394167326
Total Pages : 319 pages
Book Rating : 4.3/5 (941 download)

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Book Synopsis Advances in Analytical Techniques for Forensic Investigation by : Priyanka Chhabra

Download or read book Advances in Analytical Techniques for Forensic Investigation written by Priyanka Chhabra and published by John Wiley & Sons. This book was released on 2024-08-06 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is essential for anyone seeking to understand and apply the latest analytical techniques in forensic investigation, saving time, materials, energy, and manpower by providing guidance on the most appropriate techniques for different types of investigations. Advances in Analytical Techniques for Forensic Investigation is aimed to describe the applicability of different types of analytical techniques used for the forensic investigation, including FT-IR, chromatography, mass spectroscopy, NMR spectroscopy, atomic absorption spectroscopy, UV- vis spectroscopy, etc. This book will focus on current and emerging developments in the latest analytical techniques and methods used in the forensic investigation and sample analysis of various physical, chemical, and biological samples in order to facilitate the smooth conduction of justice.

Method Validation in Pharmaceutical Analysis

Author : Joachim Ermer
Publisher : John Wiley & Sons
ISBN 13 : 3527604472
Total Pages : 418 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Method Validation in Pharmaceutical Analysis by : Joachim Ermer

Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

Analytical Method Development and Validation

Author : Michael E. Swartz
Publisher : CRC Press
ISBN 13 : 1482229773
Total Pages : 95 pages
Book Rating : 4.4/5 (822 download)

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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 2018-10-03 with total page 95 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.

Introduction to Pharmaceutical Chemical Analysis

Author : Steen Honoré Hansen
Publisher : John Wiley & Sons
ISBN 13 : 1119954339
Total Pages : 511 pages
Book Rating : 4.1/5 (199 download)

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Book Synopsis Introduction to Pharmaceutical Chemical Analysis by : Steen Honoré Hansen

Download or read book Introduction to Pharmaceutical Chemical Analysis written by Steen Honoré Hansen and published by John Wiley & Sons. This book was released on 2011-10-18 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook is the first to present a systematic introduction to chemical analysis of pharmaceutical raw materials, finished pharmaceutical products, and of drugs in biological fluids, which are carried out in pharmaceutical laboratories worldwide. In addition, this textbook teaches the fundamentals of all the major analytical techniques used in the pharmaceutical laboratory, and teaches the international pharmacopoeias and guidelines of importance for the field. It is primarily intended for the pharmacy student, to teach the requirements in “analytical chemistry” for the 5 years pharmacy curriculum, but the textbook is also intended for analytical chemists moving into the field of pharmaceutical analysis. Addresses the basic concepts, then establishes the foundations for the common analytical methods that are currently used in the quantitative and qualitative chemical analysis of pharmaceutical drugs Provides an understanding of common analytical techniques used in all areas of pharmaceutical development Suitable for a foundation course in chemical and pharmaceutical sciences Aimed at undergraduate students of degrees in Pharmaceutical Science/Chemistry Analytical Science/Chemistry, Forensic analysis Includes many illustrative examples

HPLC for Pharmaceutical Scientists

Author : Yuri V. Kazakevich
Publisher : John Wiley & Sons
ISBN 13 : 0470087943
Total Pages : 1136 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis HPLC for Pharmaceutical Scientists by : Yuri V. Kazakevich

Download or read book HPLC for Pharmaceutical Scientists written by Yuri V. Kazakevich and published by John Wiley & Sons. This book was released on 2007-02-16 with total page 1136 pages. Available in PDF, EPUB and Kindle. Book excerpt: HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry. In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided. This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development. The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.

Calibration and Validation of Analytical Methods

Author : Mark Stauffer
Publisher : BoD – Books on Demand
ISBN 13 : 1789230845
Total Pages : 176 pages
Book Rating : 4.7/5 (892 download)

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Book Synopsis Calibration and Validation of Analytical Methods by : Mark Stauffer

Download or read book Calibration and Validation of Analytical Methods written by Mark Stauffer and published by BoD – Books on Demand. This book was released on 2018-04-25 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

9th Edition of International Conference on Mass Spectrometry 2019

Author : Euroscicon
Publisher : EuroScicon
ISBN 13 :
Total Pages : 46 pages
Book Rating : 4./5 ( download)

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Book Synopsis 9th Edition of International Conference on Mass Spectrometry 2019 by : Euroscicon

Download or read book 9th Edition of International Conference on Mass Spectrometry 2019 written by Euroscicon and published by EuroScicon. This book was released on 2019-02-25 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt: March 04-05, 2019, Best Western Premier Airport hotel Fontane Berlin. Key Topics: New Advances And Development In Mass Spectrometry, Mass Spectrometry Applications In Organic Chemistry, Mass Spectrometry Applications, Mass Spectrometry In Pharmaceutical Industry, Spectroscopy, Mass Spectrometry Applications In Clinical Diagnostics, Capillary Electrophoresis, Chromatography, Tandem Mass Spectrometry, Maas Spectrometry In Environmental Analysis, Protein Mass Spectrometry, Ionization Techniques Mass Spectrometry, Mass Spectrometry Instrumentation, Forensic Analysis, Mass Spectrometry In Medicine, Imaging Mass Spectrometry, Analytical Chemistry, Proteomics

Pharmaceutical Analysis for Small Molecules

Author : Behnam Davani
Publisher : John Wiley & Sons
ISBN 13 : 1119425018
Total Pages : 211 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Pharmaceutical Analysis for Small Molecules by : Behnam Davani

Download or read book Pharmaceutical Analysis for Small Molecules written by Behnam Davani and published by John Wiley & Sons. This book was released on 2017-08-01 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Flow Injection Analysis

Author : B. Karlberg
Publisher : Elsevier
ISBN 13 : 0080875580
Total Pages : 385 pages
Book Rating : 4.0/5 (88 download)

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Book Synopsis Flow Injection Analysis by : B. Karlberg

Download or read book Flow Injection Analysis written by B. Karlberg and published by Elsevier. This book was released on 1989-08-04 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a practical guide for first-time and experienced users of Flow Injection Analysis (FIA). It gives, not a detailed theoretical analysis, but a ``nuts and bolts'' approach to the description of the technique and how it can be utilized to solve analytical chemical problems.The advantages of flow injection, how, when, why and where it works are all fully explained. Criteria for the choice of hardware and useful hints for maintenance are provided. The large variety of detectors suitable to combine with FIA are discussed, as are special modes of operation, their advantages and their limitations, and also conversion of batch methods to FIA methods. Numerous in-depth descriptions of applications of FIA techniques in water, soil, pharmaceutical and industrial analysis are featured, and a complete bibliography is included.The authors have spent several years demonstrating, lecturing and using FIA and the basic outline of their book closely follows the schedule of the FIA workshops they have taught. It will be an invaluable tool for all chemists who perform analyses on a routine basis.

The Treatment of Epilepsy

Author : Simon Shorvon
Publisher : John Wiley & Sons
ISBN 13 : 1118936981
Total Pages : 1072 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis The Treatment of Epilepsy by : Simon Shorvon

Download or read book The Treatment of Epilepsy written by Simon Shorvon and published by John Wiley & Sons. This book was released on 2015-09-15 with total page 1072 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highly Commended at the British Medical Association Book Awards 2016 The Treatment of Epilepsy, fourth edition, is a comprehensive reference and clinical guide to the pharmacological, medical and surgical options available in the treatment of epilepsy. The text is compiled by a group of internationally renowned editors and contributors and is now in full color and extensively illustrated The first two sections cover the background to, and principles of, treatment in different clinical situations Section three comprises a series of systematic reviews of contemporary drug therapy, devoting one chapter to each anti-epileptic drug and covering all clinically-relevant aspects Section four focuses on the surgical options, devoting individual chapters to each of the modalities of presurgical assessment and to each surgical operation or approach This 4th edition is extensively revised incorporating the many recent developments in therapy, and comprises 81 chapters from world experts from 18 countries

Introduction to Pharmaceutical Analytical Chemistry

Author : Stig Pedersen-Bjergaard
Publisher : John Wiley & Sons
ISBN 13 : 111936275X
Total Pages : 752 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis Introduction to Pharmaceutical Analytical Chemistry by : Stig Pedersen-Bjergaard

Download or read book Introduction to Pharmaceutical Analytical Chemistry written by Stig Pedersen-Bjergaard and published by John Wiley & Sons. This book was released on 2019-02-11 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt: The definitive textbook on the chemical analysis of pharmaceutical drugs – fully revised and updated Introduction to Pharmaceutical Analytical Chemistry enables students to gain fundamental knowledge of the vital concepts, techniques and applications of the chemical analysis of pharmaceutical ingredients, final pharmaceutical products and drug substances in biological fluids. A unique emphasis on pharmaceutical laboratory practices, such as sample preparation and separation techniques, provides an efficient and practical educational framework for undergraduate studies in areas such as pharmaceutical sciences, analytical chemistry and forensic analysis. Suitable for foundational courses, this essential undergraduate text introduces the common analytical methods used in quantitative and qualitative chemical analysis of pharmaceuticals. This extensively revised second edition includes a new chapter on chemical analysis of biopharmaceuticals, which includes discussions on identification, purity testing and assay of peptide and protein-based formulations. Also new to this edition are improved colour illustrations and tables, a streamlined chapter structure and text revised for increased clarity and comprehension. Introduces the fundamental concepts of pharmaceutical analytical chemistry and statistics Presents a systematic investigation of pharmaceutical applications absent from other textbooks on the subject Examines various analytical techniques commonly used in pharmaceutical laboratories Provides practice problems, up-to-date practical examples and detailed illustrations Includes updated content aligned with the current European and United States Pharmacopeia regulations and guidelines Covering the analytical techniques and concepts necessary for pharmaceutical analytical chemistry, Introduction to Pharmaceutical Analytical Chemistry is ideally suited for students of chemical and pharmaceutical sciences as well as analytical chemists transitioning into the field of pharmaceutical analytical chemistry.

Recent Trends in Pharmaceutical Analytical Chemistry

Author : Constantinos K. Zacharis
Publisher : MDPI
ISBN 13 : 3036507981
Total Pages : 166 pages
Book Rating : 4.0/5 (365 download)

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Book Synopsis Recent Trends in Pharmaceutical Analytical Chemistry by : Constantinos K. Zacharis

Download or read book Recent Trends in Pharmaceutical Analytical Chemistry written by Constantinos K. Zacharis and published by MDPI. This book was released on 2021-09-01 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers the most recent research trends and applications of Pharmaceutical Analytical Chemistry. The included topics range from the adulteration of dietary supplements, to the determination of drugs in biological samples with the aim to investigate their pharmacokinetic properties.