HPLC in the Pharmaceutical Industry

Author: Godwin W. Fong

Publisher: CRC Press

ISBN: 9780824784997

Category: Science

Page: 326

View: 4220

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A practical guide for chemists in the pharmaceutical industry to making automated analyses of drugs that will meet the standards of regulatory agencies. Reviews the standard techniques of high-performance liquid chromatography, specialized detection methods, automation in pharmaceutical analysis, an
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HPLC for Pharmaceutical Scientists

Author: Yuri V. Kazakevich,Rosario LoBrutto

Publisher: John Wiley & Sons

ISBN: 0470087943

Category: Science

Page: 1080

View: 4058

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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.
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Handbook of Pharmaceutical Analysis by HPLC

Author: Satinder Ahuja,Michael Dong

Publisher: Elsevier

ISBN: 9780080455181

Category: Medical

Page: 600

View: 6437

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High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
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Pharmaceutical Analysis for Small Molecules

Author: Behnam Davani

Publisher: John Wiley & Sons

ISBN: 1119121116

Category: Medical

Page: 256

View: 4779

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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.
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HPLC Method Development for Pharmaceuticals

Author: Satinder Ahuja,Henrik Rasmussen

Publisher: Elsevier

ISBN: 0080554199

Category: Medical

Page: 532

View: 1764

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High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge. Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities) Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase
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High-Throughput Analysis in the Pharmaceutical Industry

Author: Perry G. Wang

Publisher: CRC Press

ISBN: 9781420059540

Category: Medical

Page: 432

View: 8674

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The introduction of combinatorial chemistry technology has increased the amount of compounds generated in a year from 50 to 2000. Conventional analytical approaches simply cannot keep up. These circumstances have caused drug discovery to take on the shape of a bottleneck, like traffic through a toll booth. In order to break the bottleneck, a corresponding revolutionary improvement to the conventional methodology must happen.
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Process Chemistry in the Pharmaceutical Industry

Author: Kumar Gadamasetti

Publisher: CRC Press

ISBN: 9780824719814

Category: Medical

Page: 500

View: 1321

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Providing guidance for chemists and other scientists entering pharmaceutical discovery and development, this up-to-the-minute reference presents contributions from an international group of nearly 50 renowned researchers—offering a solid grounding in synthetic and physical organic chemistry, and clarifying the roles of various specialties in the development of new drugs. Featuring over 1000 references, tables, and illustrations, Process Chemistry in the Pharmaceutical Industry is sure to find its way to the bookshelves of organic, physical, analytical, process, and medicinal chemists and biochemists; pharmacists; and upper-level undergraduate and graduate students in these disciplines.
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Job$ in the Drug Indu$try

A Career Guide for Chemists

Author: Richard J. Friary

Publisher: Elsevier

ISBN: 9780080509624

Category: Science

Page: 364

View: 2074

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This book is intended to help newly graduated chemists, particularly organic chemists, at all levels from bachelors to post-doctorates, find careers in the North American pharmaceutical industry. It will serve as a practical, detailed guiedbook for job seekers as well a reference work for faculty advisers, research supervisors, development officers, employment agents, and personnel managers in the industry. The book gathers in a single volume the fundamentals of getting an industrial job as a medicinal or process chemist, and covers all aspects of a chemist's job--scientific, financial, and managerial--within a pharmaceutical/biotechnology company. Other scientists looking for jobs as analytical or physical chemists and even biochemists and biologists will find the book useful. The valuable appendix is a unique compendium of 365 commercial, governmental, or non-profit institutions that comprise the North American pharmaceutical industry. Learn How To: Discover the 12 permanent, big-pharma jobs for B.S. chemists Use the 500+ company index to locate potential employers Track pharma openings with 190+ corporate and chemist-specific job banks Add industry veterans to your employment network Find the 50+ companies offering paid summer internships to students Include the one resume item that wins interviews for B.S. and M.S. chemists Express a knowledgeable preference for drug discovery or development Research over 360 drug companies through their Web sites Discover the 70+ firms offering stock purchase plans or stock options3⁄4and which two represent big pharma Find out your salary offer in time to negotiate your wages
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Clarke's Isolation and Identification of Drugs in Pharmaceuticals, Body Fluids, and Post-mortem Material

Author: Eustace George Coverley Clarke,A. C. Moffat,Pharmaceutical Society of Great Britain. Dept. of Pharmaceutical Sciences

Publisher: N.A

ISBN: N.A

Category: Drug adulteration

Page: 1223

View: 2728

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Provides the means to identify and quantify drugs and other toxic substances in situations of overdose or poisoning and to interpret analytical results. Includes an analysis of toxic metals and pesticides.
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