Basic Tests For Pharmaceutical Substances

Author : World Health Organization
Publisher : World Health Organization
Page : 104 pages
File Size : 51,6 Mb
Release : 1998
Category : Health & Fitness
ISBN : 9241545135

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Basic Tests for Drugs by World Health Organization Pdf

This book provides a step-by-step guide to simple methods for verifying the identity of commonly used pharmaceutical substances and dosage forms. The basic tests described can also be used to detect mislabeled, substandard, or counterfeit products when the labeling or physical attributes give rise to doubt. Intended for use in developing countries, where resources and specialized skills may be scarce, all tests rely on a limited range of easily available reagents and equipment and need not be performed in a fully equipped laboratory or by persons with specialized training in pharmacy or chemistry. The book describes tests for 23 pharmaceutical substances and 58 pharmaceutical dosage forms, most of which are included in the WHO Model List of Essential Drugs. Basic tests for confirming the identity of four commonly used medicinal plant materials are also included. As stressed in the text, these tests, which merely confirm identity, are intended for use as primary screening tools and may need to be followed, in cases of adverse test results, by a full pharmacopoeial analysis. The book opens with a brief description of the importance of basic tests as one of the many steps needed to ensure a supply of safe and effective drugs. Chapter two describes several collections of more sophisticated tests, including volumetric or spectrophotometric analysis and thin-layer chromatography, that can be useful in the primary screening of imported pharmaceutical substances, and dosage forms. Information on how to obtain and use these guides to tests, which have not been published by WHO is also provided. Against this background, the main part of the book sets out test procedures for verifying the identity of selected pharmaceutical substances, pharmaceutical dosage forms, and medicinal plant materials. The book concludes with a cumulative index of test procedures described here and in the related WHO publications "Basic Tests for Pharmaceutical Substances" and "Basic Tests for Pharmaceutical Dosage Forms".

Author : Anonim
Publisher : Unknown
Page : 205 pages
File Size : 54,8 Mb
Release : 2007
Category : Electronic
ISBN : 8185386277

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Basic Tests For Pharmaceutical Substances, 1/Ed. by Anonim Pdf

Author : World Health Organization
Publisher : Unknown
Page : 246 pages
File Size : 53,5 Mb
Release : 1986
Category : Science
ISBN : UOM:39015012540061

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Basic Tests for Pharmaceutical Substances by World Health Organization Pdf

Author : World Health Organization
Publisher : World Health Organization
Page : 144 pages
File Size : 50,6 Mb
Release : 1991
Category : Medical
ISBN : 924154418X

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Basic Tests for Pharmaceutical Dosage Forms by World Health Organization Pdf

Author : Anonim
Publisher : Unknown
Page : 129 pages
File Size : 45,8 Mb
Release : 2008
Category : Drugs
ISBN : 8185386501

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Basic Tests for Pharmaceutical Dosage Forms by Anonim Pdf

Author : World Health Organization
Publisher : World Health Organization
Page : 122 pages
File Size : 42,8 Mb
Release : 1998
Category : Medical
ISBN : 9789241545105

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Quality Control Methods for Medicinal Plant Materials by World Health Organization Pdf

A collection of test procedures for assessing the identity, purity, and content of medicinal plant materials, including determination of pesticide residues, arsenic and heavy metals. Intended to assist national laboratories engaged in drug quality control, the manual responds to the growing use of medicinal plants, the special quality problems they pose, and the corresponding need for international guidance on reliable methods for quality control. Recommended procedures - whether involving visual inspection or the use of thin-layer chromatography for the qualitative determination of impurities - should also prove useful to the pharmaceutical industry and pharmacists working with these materials.

Author : Institute of Medicine,Board on Global Health,Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products
Publisher : National Academies Press
Page : 377 pages
File Size : 53,8 Mb
Release : 2013-06-20
Category : Medical
ISBN : 9780309269391

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Countering the Problem of Falsified and Substandard Drugs by Institute of Medicine,Board on Global Health,Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products Pdf

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.

Author : Anonim
Publisher : Unknown
Page : 136 pages
File Size : 49,5 Mb
Release : 2003-01-01
Category : Health & Fitness
ISBN : 9241209089

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WHO Expert Committee on Specifications for Pharmaceutical Preparations by Anonim Pdf

This report presents the recommendations relating to the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. It includes discussions concerning the development of the International Pharmacopoeia and basic tests for pharmaceutical substances and dosage forms as well as general quality control issues.

Author : Eustace George Coverley Clarke
Publisher : Unknown
Page : 680 pages
File Size : 42,7 Mb
Release : 2004
Category : Analytical toxicology
ISBN : UOM:39015058787154

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Clarke's Analysis of Drugs and Poisons by Eustace George Coverley Clarke Pdf

This manual and reference work provides a source of analytical data for drugs and related substances. It is intended for scientists faced with the difficult problem of identifying a drug in a pharmaceutical product, in a sample of tissue or body fluid, from a living patient or in post-mortem material. Volume One contains 32 chapters covering the practice of and analytical procedures used in forensic toxicology. Volume Two contains over 1750 drug and related substance monographs detailing: physical properties; analytical methods; pharmacokinetic data; and toxicity data, as well as expanded indexes and appendices. These volumes should be useful for all forensic and crime laboratories, toxicologists and analytical chemists, pathologists, poison information centres and clinical pharmacology departments.

Author : National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research
Publisher : National Academies Press
Page : 23 pages
File Size : 52,8 Mb
Release : 2006-02-19
Category : Science
ISBN : 9780309101172

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Science, Medicine, and Animals by National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research Pdf

Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.

Author : Christopher M. Riley,Thomas W. Rosanske
Publisher : Elsevier
Page : 349 pages
File Size : 50,5 Mb
Release : 1996-05-29
Category : Science
ISBN : 0080530354

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Development and Validation of Analytical Methods by Christopher M. Riley,Thomas W. Rosanske Pdf

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.

Author : World Health Organization
Publisher : World Health Organization
Page : 414 pages
File Size : 43,7 Mb
Release : 2007
Category : Business & Economics
ISBN : 9789241547086

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Quality Assurance of Pharmaceuticals by World Health Organization Pdf

Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.

Author : Dr. Dillip Kumar Jena,Dr. Pankaj Pradhan
Publisher : Thakur Publication Private Limited
Page : 200 pages
File Size : 51,8 Mb
Release : 2021-04-14
Category : Education
ISBN : 9789390972104

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Quality Control and Standardization Of Herbals by Dr. Dillip Kumar Jena,Dr. Pankaj Pradhan Pdf

Purchase the e-Book version of ‘Quality Control and Standardization of Herbals’ for B.Pharm 8th Semester, meticulously aligned with the PCI Syllabus. Published by Thakur Publication, this digital edition offers a comprehensive exploration of advanced instrumentation techniques at your fingertips. Upgrade your learning experience with the convenience and portability of an e-Book. Dive into the world of cutting-edge pharmaceutical instrumentation with ease. Get your copy today and embark on a journey of enhanced understanding.

Author : Ronny Priefer
Publisher : CRC Press
Page : 192 pages
File Size : 47,8 Mb
Release : 2023-08-10
Category : Medical
ISBN : 9781000914016

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Quantitative and Qualitative Determination Technologies of Counterfeit Drugs by Ronny Priefer Pdf

Drugs are often counterfeited to reduce manufacture costs, while still marketing it at as an authentic product. Increased incidence of drug counterfeiting is most noticeable in developing countries, which may not have the resources to supply counterfeit detection devices on a large scale. It is important to consider the problems caused and to propose options for controlling and reducing the prevalence of counterfeit medications. Various technologies are needed to identify the chemical properties of a questioned medicinal product, which can then be used to determine its authenticity. This volume focuses on current technological approaches that are able to detect counterfeited pharmaceuticals. Features Focuses on current technological approaches that are able to detect counterfeited pharmaceuticals Assesses the chemical methods of identifying counterfeit medicinal products and explains the theoretical underpinnings of the methods Provides case study type examples of the application for analysis of suspected counterfeit pharmaceuticals Discusses the detection and analysis of counterfeit drugs, and appropriate tools for combating this issue The editor draws on his experience as a respected chemist and prolific author in the field to provide this unique text on drug counterfeiting detection

Author : Anonim
Publisher : Unknown
Page : 28 pages
File Size : 47,8 Mb
Release : 2000
Category : Chemical tests and reagents
ISBN : PURD:32754069272999

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Color Test Reagents/kits for Preliminary Identification of Drugs of Abuse by Anonim Pdf