A Manual of Analytical Chemistry and Pharmaceutical Assaying PDF Download

Author: Samuel Philip Sadtler
Publisher:
ISBN:
Category :
Languages : en
Pages : 344

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Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 0080455182
Category : Medical
Languages : en
Pages : 679

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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

Author: Kim Huynh-Ba
Publisher: John Wiley & Sons
ISBN: 1119120918
Category : Science
Languages : en
Pages : 420

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Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs.

Author: Steen Honoré Hansen
Publisher: John Wiley & Sons
ISBN: 1119954339
Category : Science
Languages : en
Pages : 511

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Book Description
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

Author:
Publisher:
ISBN:
Category : American literature
Languages : en
Pages : 864

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Author: Carl Friedrich Plattner
Publisher:
ISBN:
Category : Blowpipe
Languages : en
Pages : 496

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Author: Samuel Philip Sadtler
Publisher:
ISBN:
Category :
Languages : en
Pages : 344

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Author: Peter C. Meier
Publisher: John Wiley & Sons
ISBN: 0471726117
Category : Science
Languages : en
Pages : 452

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Book Description
This new edition of a successful, bestselling book continues to provide you with practical information on the use of statistical methods for solving real-world problems in complex industrial environments. Complete with examples from the chemical and pharmaceutical laboratory and manufacturing areas, this thoroughly updated book clearly demonstrates how to obtain reliable results by choosing the most appropriate experimental design and data evaluation methods. Unlike other books on the subject, Statistical Methods in Analytical Chemistry, Second Edition presents and solves problems in the context of a comprehensive decision-making process under GMP rules: Would you recommend the destruction of a $100,000 batch of product if one of four repeat determinations barely fails the specification limit? How would you prevent this from happening in the first place? Are you sure the calculator you are using is telling the truth? To help you control these situations, the new edition: * Covers univariate, bivariate, and multivariate data * Features case studies from the pharmaceutical and chemical industries demonstrating typical problems analysts encounter and the techniques used to solve them * Offers information on ancillary techniques, including a short introduction to optimization, exploratory data analysis, smoothing and computer simulation, and recapitulation of error propagation * Boasts numerous Excel files and compiled Visual Basic programs-no statistical table lookups required! * Uses Monte Carlo simulation to illustrate the variability inherent in statistically indistinguishable data sets Statistical Methods in Analytical Chemistry, Second Edition is an excellent, one-of-a-kind resource for laboratory scientists and engineers and project managers who need to assess data reliability; QC staff, regulators, and customers who want to frame realistic requirements and specifications; as well as educators looking for real-life experiments and advanced students in chemistry and pharmaceutical science. From the reviews of Statistical Methods in Analytical Chemistry, First Edition: "This book is extremely valuable. The authors supply many very useful programs along with their source code. Thus, the user can check the authenticity of the result and gain a greater understanding of the algorithm from the code. It should be on the bookshelf of every analytical chemist."-Applied Spectroscopy "The authors have compiled an interesting collection of data to illustrate the application of statistical methods . . . including calibrating, setting detection limits, analyzing ANOVA data, analyzing stability data, and determining the influence of error propagation."-Clinical Chemistry "The examples are taken from a chemical/pharmaceutical environment, but serve as convenient vehicles for the discussion of when to use which test, and how to make sense out of the results. While practical use of statistics is the major concern, it is put into perspective, and the reader is urged to use plausibility checks."-Journal of Chemical Education "The discussion of univariate statistical tests is one of the more thorough I have seen in this type of book . . . The treatment of linear regression is also thorough, and a complete set of equations for uncertainty in the results is presented . . . The bibliography is extensive and will serve as a valuable resource for those seeking more information on virtually any topic covered in the book."-Journal of American Chemical Society "This book treats the application of statistics to analytical chemistry in a very practical manner. [It] integrates PC computing power, testing programs, and analytical know-how in the context of good manufacturing practice/good laboratory practice (GMP/GLP) . . .The book is of value in many fields of analytical chemistry and should be available in all relevant libraries."-Chemometrics and Intelligent Laboratory Systems

Author: Mr. Sushant Sudhir Pande
Publisher: Trinity Publishing House, Satara
ISBN: 8196569424
Category : Medical
Languages : en
Pages : 124

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We are very pleased to putforth 'Laboratory Manual of Pharmaceutical Analysis-I'. This manual is designed as per syllabus set by PCI for first year degree course in pharmacy as per PCI B. Pharm course regulations 2014. This manual is a sincere effort to improve the practical skills of students so that every student will understand the objective of each experiment and perform the practical easily. This manual is designed for 'outcome-based education' and each experiment is arranged in uniform way such as Aim, Practical Significance, Practical Outcomes, Theory, Resources Required, Precautions, Procedure, Observations, Calculations, Results, Conclusion, References and Synopsis Questions. Theory of each experiment is given in all fifteen experiments making the manual more interesting. The manual also focuses on practical skills as well as on the observation tables and calculations that will be helpful in qualitative and quantitative analysis. The experiments designed in this manual are written after practical performance in the laboratory by author themselves. We welcome all the suggestions from teachers and students regarding the conduct of the practical. Also, you can put your queries in case of difficulties directly to us, so that the effective solution can be given to you. We are always with you to support and help, so feel free to interact with us. We look forward for your valuable feedback regarding manual. We acknowledge the help and co-operation extended by various persons in bringing out this manual. We are highly indebted to the authors of various books and articles mentioned in bibliography which became a major source of information for writing this manual. We also thank the publishers, designers and printers who graciously worked hard to publish this manual in time.

Author:
Publisher:
ISBN:
Category : American literature
Languages : en
Pages : 2188

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