Analysis of 23 Elements in Wastewater by U.S. EPA Method 6020B Using ICPMS-2050

For the analysis of heavy metals in wastewater, the methods of the US Environmental Protection Agency (EPA) are considered reference for analysis worldwide. The US EPA published Method 6020B to control 23 metals in environmental water using ICP-MS. ICP-MS can analyze many elements at the ppt levels and allows for simultaneous analysis by directly introducing wastewater samples. 

 In this Application News, 23 elements in wastewater were analyzed using the ICPMS-2050. Analytical samples’ spike recovery tests and long-term stability tests were performed in accordance with the quality control (QC) requirements of the EPA Method 6020B.

Download Full Text Here

A Textbook Of Pharmaceutical Analysis, 3rd Edition

This book is a detailed, systematic treatment of analytically chemistry, focusing on drug analysis. It covers both classical techniques and modern approaches. It includes new sections on immunoassay, derivative formation, and statistical interpretation of data. Also includes an expanded treatment of liquid chromatography, as well as over 250 problems, many with solutions provided.

Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying CD-ROM comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management.

• Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues

• Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements

• Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries

• Includes a CD with downloadable training courses that can be adopted and directly customized to a particular organization

• Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate

The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the CD supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance. 

Download

Clarke's Analysis of Drugs and Poisons, 4th Edition

Clarke's Analysis of Drugs and Poisons, 4th Edition is now being offered solely as a print and online package. It is a full book & digital package, consisting of the two volume reference book in a slip case, plus one year's individual access to the online version of Clarke's via Medicines Complete, with all the attendant benefits, including updating annually.

MedicinesComplete is produced and updated by Pharmaceutical Press.

Clarke's Analysis of Drugs and Poisons is the definitive source of analytical data for drugs and poisons. Written by over 40 international experts, the resource also boasts an editorial advisory board of over 45 world renowned scientists.

This reference work has been completely revised and updated for the new edition, and comprises two volumes.

The book is essential for all forensic and clinical toxicologists, pathologists, hospital pharmacists, pharmaceutical analysts, clinical pharmacologists, clinical and forensic laboratories, and poison information centers.

Download

Encyclopedia of Analytical Science, 2nd Edition

As with the first edition of the Encyclopedia of Analytical Science, this second edition is designed to provide a detailed and comprehensive publication covering all facets of the science and practice of analysis. The new work has been extensively revised in terms of the titles and content of the first edition, and includes comprehensive coverage of techniques used for the determination of specific elements, compounds and groups of compounds, in physical or biological matrices.

Download

Gareth Thomas, "Medicinal Chemistry: An Introduction"

Medicinal Chemistry: An Introduction, Second Edition provides a comprehensive, balanced introduction to this evolving and multidisciplinary area of research. Building on the success of the First Edition, this edition has been completely revised and updated to include the latest developments in the field.

Written in an accessible style, Medicinal Chemistry: An Introduction, Second Edition carefully explains fundamental principles, assuming little in the way of prior knowledge. The book focuses on the chemical principles used for drug discovery and design covering physiology and biology where relevant. It opens with a broad overview of the subject with subsequent chapters examining topics in greater depth.

Download

Sample Sizes for Clinical Trials

With worked examples and problems based on real-world scenarios, this book takes readers through the process of calculating the sample size for many types of clinical trials. It covers the most common types of clinical trials across all phases. The author discusses how assumptions made in a sample size calculation can impact the calculation. He provides calculations for many of the trials and offers hints and tips on how to optimize the calculations. He also illustrates the steps involved in determining sample size, from defining the trial objective to selecting an appropriate endpoint.

Download

Guidance for the Implementation of a Quality Management System in Drug Testing Laboratories

Offers guidance for the implementation of a quality management system in drug testing laboratories: a commitment to quality and continuous improvement.
The quality of analyses and results of drug analysis laboratories have significant implications for the justice system, law enforcement, crime prevention and health policy, as well as for the international harmonization and worldwide exchange and coordination of drug information and data. The document aims to provide guidance to deliver high quality in a forensic laboratory, use the appropriate techniques to find the "answers" and to improve it constantly. It is a "how to do document" and includes some areas that are not explicitly covered in depth by ISO 17025.

Download

Handbook of Pharmaceutical Excipients, 6th Edition

"The Handbook of Pharmaceutical Excipients" is internationally recognised as the authoritative source of information on pharmaceutical excipients. "The Handbook of Pharmaceutical Excipients" is a comprehensive guide to the uses, properties and safety of pharmaceutical excipients and is an essential reference for those involved in the development, production, control or regulation of pharmaceutical preparations. The handbook collects together essential data on the physical properties of excipients as well as providing information on their safe use and potential toxicity. All monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names.

Download (UPDATED)

Martindale: The Complete Drug Reference, 36th Edition

This book provides reliable, unbiased and evaluated information on drugs and medicines used throughout the world. Each new drug licensed for use has its own potential benefits and adverse effects, and its own profile for dosage, administration and indications. Furthermore, manufacturers make regular changes to existing drug names and formulations, which can affect their interactions and safe usage. Health professionals require the correct answers and need to have confidence in the drugs information they use - but with medicines evolving at this rate, how can they be sure their knowledge is up to date? "Martindale" contains up to date information about more than 5,800 substances. Each and every entry is reviewed by our pharmaceutical editors to ensure health professionals have the most current data. Formulations change. Definitions change. Names change. But you can always trust "Martindale".

Download [Support us for this link by visiting ads on download page or by some donation]

Pharmaceutical Drug Analysis

During the past two decades, there have been magnificent and significant advances in both analytical instrumentation and computerized data handling devices across the globe. In this specific context the remarkable proliferation of windows-based computer software stretched overwhelmingly towards instrument control, real time data handling abilities and the ultimate usage of Laboratory Information Management Systems (LIMS) are surprisingly noteworthy.

Pharmaceutical Drug Analysis in its present form essentially comprises six parts containing in all 32 well-elaborated chapters predominantly dealing with the set of descriptive analytical methodologies developed to control and assure the quality of the final marketed product; and, therefore, includes both qualitative and quantitative methods of analysis to help in the identification as well as purity of the product.

The main purpose of this textbook is to discuss in an explicit and lucid manner several of the newer methods that now find rather wider application in the domain of pharmaceutical analysis. The basic principle of each technique is critically treated with emphasis on factors that directly affect its proper and judicious application to various analytical problems. An in-depth knowledge of these principles, instrumentations, modus operandi, experimental parameters, and sample preparation procedures in order to optimize the performance procedure of typical assay of pharmaceutical secondary products i.e., dosage forms, calculations etc., along with cognate assays from the Official Compendia have been included profusely.

Undergraduate and postgraduate students of pharmaceutical drug analysis, quality assurance chemists, industrial trainees, bulk-drug professionals and those in related disciplines earnestly requiring a substantial fundamental understanding and knowledge of the subject will certainly find this a much needed suitable compilation for reading and reference.

The broad coverage included in each of the selected analytical techniques would render Pharmaceutical Drug Analysis to be an useful source of ideas, inspiration for research, and developing newer practical solutions to problems in the ever expanding field of pharmaceutical analysis.

Download

Pericyclic Reactions (Oxford Chemistry Primers, 67)

Pericyclic reaction - the third type of organic reaction mechanism along with ionic and radical reactions - include some of the most powerful synthetically useful reactions, like the Diels - Alder reaction, 1,3- dipolar cycloadditions, the Alder ene reaction, Claisen rearrangements, the 2,3-Wittig rearrangement, diimide reduction, sulfoxide elimination and many others. These reactions are characterised by having cyclic transition structures, and also have highly predictable stereochemical features. Every organic chemist must be able to recognise the various types of pericyclic reaction and know something of their mechanisms and the factors that affect how well they work in organic synthesis. This book identifies the four main classes of pericyclic reaction, and discusses the main characteristics of the most important class, cycloadditions - providing a working knowledge, based on real examples, of their scope, patterns of reactivity, and stereochemistry. Then it explains the main features using ideas based in molecular orbital theory, but ( as in the companion book by A. J. Kirby on Stereoelectronic Effects ) without mathematics. It presents the Woodward - Hoffmann rules in the form of two all-encompassing rules, one for thermal reactions and its opposite for photochemical reactions. These rules are explained in detail and carefully illustrated, so that you will be able to predict the stereochemical outcome for any pericyclic reaction. The remaining chapters use this theoretical framework to show how the rules work with the other three classes of pericyclic reactions - electrocyclic reactions, sigmatropic rearrangements and group transfer reactions. By the end of the book, you will be able to recognise any pericyclic reaction and predict with confidence whether it is allowed, and with what stereochemistry, and you will have a working knowledge of the range of pericyclic reactions available to the synthetic organic chemist.

Download

Drug-like Properties: Concepts, Structure Design and Methods: from ADME to Toxicity Optimization

Of the thousands of novel compounds that a drug discovery project team invents and that bind to the therapeutic target, typically only a fraction of these have sufficient ADME/Tox properties to become a drug product. Understanding ADME/Tox is critical for all drug researchers, owing to its increasing importance in advancing high quality candidates to clinical studies and the processes of drug discovery. If the properties are weak, the candidate will have a high risk of failure or be less desirable as a drug product. This book is a tool and resource for scientists engaged in, or preparing for, the selection and optimization process.

The authors describe how properties affect in vivo pharmacological activity and impact in vitro assays. Individual drug-like properties are discussed from a practical point of view, such as solubility, permeability and metabolic stability, with regard to fundamental understanding, applications of property data in drug discovery and examples of structural modifications that have achieved improved property performance. The authors also review various methods for the screening (high throughput), diagnosis (medium throughput) and in-depth (low throughput) analysis of drug properties.

* Serves as an essential working handbook aimed at scientists and students in medicinal chemistry

* Provides practical, step-by-step guidance on property fundamentals, effects, structure-property relationships, and structure modification strategies

* Discusses improvements in pharmacokinetics from a practical chemist's standpoint.

Download

Name Reactions and Reagents in Organic Synthesis

This Second Edition is the premier name resource in the field. It provides a handy resource for navigating the web of named reactions and reagents. Reactions and reagents are listed alphabetically, followed by relevant mechanisms, experimental data (including yields where available), and references to the primary literature. The text also includes three indices based on reagents and reactions, starting materials, and desired products. Organic chemistry professors, graduate students, and undergraduates, as well as chemists working in industrial, government, and other laboratories, will all find this book to be an invaluable reference.

Download

Design and Analysis of Animal Studies in Pharmaceutical Development

This practical resource provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products! Clarifying detailed presentations with real-world examples, Design and Analysis of Animal Studies in Pharmaceutical Development furnishes definitions, background information, and regulatory requirements discusses statistical designs and methods for bioassay describes techniques for estimating drug efficacy and lethal doses illustrates statistical concepts as well as design and analysis principles for toxicology studies shows how to assess carcinogenicity and teratology for drugs under development details methods of analysis for in vitro Ames tests and Chinese hamster ovary cell mutagenesis studies and more!

Download

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 2 - Regulations, Standards, and Guidelines)

Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I. The book is presented in an convenient, easy-to-read format, organized to provide fast access to the guidelines and regulations of interest.

Download

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their Suppliers, Sixth Edition, (Volume 1 - With Checklis)

Volume 1 of this three-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these are referenced to the relevant relevant FDA regulations, EC and IPEC guidelines, and ISO/BSI standards. The text also explains various audit types, do's and don'ts for auditors, and guidance for audit preparation, performance, conclusion, report derivation, and follow up activities. A CD-ROM packaged with the book contains all of the checklists in a customizable electronic format.

Download

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

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.

Download

Quality Engineering Handbook, Second Edition, Revised and Expanded (Quality and Reliability)

…a launching pad for those interested in mastering the field of quality engineering.
Journal of Quality Technology

…focused toward the goals of quality engineering, quality control, and continuous improvement…a fine effort.

…a launching pad for those interested in mastering the field of quality engineering.
Journal of Quality Technology

…focused toward the goals of quality engineering, quality control, and continuous improvement…a fine effort.

Description

Written by the one of the foremost authorities on the subject, the Second Edition is completely revised to reflect the latest changes to the ASQ Body of Knowledge for the Certified Quality Engineer (CQE); covering every essential topic required by the quality engineer for day-to-day practices in planning, testing, finance, and management. Thoroughly examines and defines the principles and benefits of Six Sigma management and organization.

Download

Drug-Drug Interactions, Second Edition

Helping researchers predict drug interactions in a more accurate and effective manner, this comprehensive volume covers every critical aspect of metabolism-based drug-drug interactions, including preclinical, clinical, toxicological, regulatory, and marketing perspectives by renowned thought leaders in their respective fields. Thoroughly updated, the Second Edition reflects key developments in the field, including an improved understanding of the relationship between transporters and enzymes in drug metabolism and drug interactions. Formatted to benefit the reader, this source provides helpful case examples, representative enzyme systems, and computer-aided modeling, as well as 200 valuable tables, equations, drawings, and photographs to clarify key concepts.

Download