Aziridines and Epoxides in Organic SynthesisAndrei K. Yudin.Publisher: Wiley-VCH Number Of Pages: 516 Publication Date: 2006-03-20 .
Wednesday, July 30, 2008
Enantioselective Synthesis of Beta Amino Acids .Eusebio Juaristi, V. A. Soloshonok
Publisher: Wiley-VCH Number Of Pages: 634 Publication Date: 2005-04-21
Reductions by the Alumino- and Borohydrides in Organic Synthesis .Reductions by the Alumino- and Borohydrides in Organic SynthesisBy Jacqueline Seyden-PennePublisher: Wiley-VCH Number Of Pages: 224 Publication Date: 1997-09-01
Free Energy Calculations in Rational Drug Design.Product Details
Hardcover: 406 pages Publisher: Springer; 1 edition (October 1, 2001) Language: English ISBN-10: 0306466767 ISBN-13: 978-0306466762
Hardcover: 406 pages Publisher: Springer; 1 edition (October 1, 2001) Language: English ISBN-10: 0306466767 ISBN-13: 978-0306466762
Chemistry: An Industry-Based Laboratory Manual (Plastic Comb).Product Details
Plastic Comb: 248 pages Publisher: CRC; 1 edition(June 23, 2000) Language: English ISBN-10: 1566703468 ISBN-13: 978-1566703468 Product Dimensions: 10 x 7.4 x 0.6 inches Shipping Weight: 1.1 pounds http://rapidshare.com/files/92533439/1566703468.rar
Hydroboration and Organic Synthesis: 9-Borabicyclo [3.3.1] nonane (9-BBN)Ranjit S. Dhillon.Description: 9-Borabicyclo [3.3.1]nonane, a commercially available reagent, is the most versatile hydroborating reagent to synthesize organoboranes (B-R-9-BBN). The reagent exhibits remarkable regio-, chemo-, and stereoselectivity during hydroboration reactions. The organoboranes can be converted to C-H, C-O, C-N, C-S, C-halogen, C-metal and above all C-C bonds. In addition, the suitable substituted / unsaturated R of B-R-9-BBN can be utilized to produce dienes, enynes, allenes etc. with defined stereochemistry. 9-BBN’s derivatives have been elegantly used for the asymmetric reduction of ketone moiety. Diels-Alder and reactions have expanded the utility of 9-BBN for the synthesis of a variety of organic compounds required for industry. Consequently, this vast field in the form of a book will be helpful to synthetic organic chemists for easy access to required for chemical transformations.
Quaternary Stereocenters: Challenges and Solutions for Organic SynthesisSteven V. Ley, Jens Christoffers, Angelika Baro.Publisher: Wiley-VCH Number Of Pages: 359 Publication Date: 2006-01-09
Filling the gap in the literature, this book presents everything there is to know about this topic. By comprehensively covering the quaternary stereocenters found in a range of important and useful molecules in pharmaceutical and medicinal applications, as well as in thousands of natural products, the book provides the know-how chemists need to synthesize challenging molecules with numerous applications.A must for organic chemists in academia, the pharmaceutical industry and medicine.From the Contents:Important Natural ProductsImportant Pharmaceuticals and IntermediatesAldol ReactionsMichael Reactions and Conjugate AdditionsCycloaddition ReactionsRearrangement ReactionsAlkylation of Ketones and IminesAsymmetric Allylic AlkylationAsymmetric Cross Coupling and Heck ReactionsPhase Transfer CatalysisEnzymatic MethodsRadical http://rapidshare.com/files/94362417/New_Folder.rar
Filling the gap in the literature, this book presents everything there is to know about this topic. By comprehensively covering the quaternary stereocenters found in a range of important and useful molecules in pharmaceutical and medicinal applications, as well as in thousands of natural products, the book provides the know-how chemists need to synthesize challenging molecules with numerous applications.A must for organic chemists in academia, the pharmaceutical industry and medicine.From the Contents:Important Natural ProductsImportant Pharmaceuticals and IntermediatesAldol ReactionsMichael Reactions and Conjugate AdditionsCycloaddition ReactionsRearrangement ReactionsAlkylation of Ketones and IminesAsymmetric Allylic AlkylationAsymmetric Cross Coupling and Heck ReactionsPhase Transfer CatalysisEnzymatic MethodsRadical http://rapidshare.com/files/94362417/New_Folder.rar
Cycloaddition Reactions in Organic SynthesisShu Kobayashi, Karl Anker Jorgensen.Publisher: Wiley-VCH Number Of Pages: 400 Publication Date: 2001-10-11
Description: Cycloaddition reactions are among the most important tools for synthesis in organic chemistry, since these reactions are vital to the modern synthesis of natural products and biologically active substances.Metal catalysis plays an increasingly important role in these reactions, often allowing several stereocenters to be selectively created and integrated in the target molecules. Kobayashi and Jorgensen's handbook provides numerous examples of metal-catalyzed reactions, including [2+1], [3+2] and [4+2] cycloadditions. Important reactions such as carbo- and hetero-Diels-Alder, carbocyclic, cyclopropanation and 1,3-dipolar cycloaddition reactions are discussed. A large number of experimental procedures gives a concrete idea of the use of metal-catalyzed cycloaddition reactions in modern synthesis.The book is aimed at chemists in industry or academia, who want to effectively use cycloadditions in their work.
Description: Cycloaddition reactions are among the most important tools for synthesis in organic chemistry, since these reactions are vital to the modern synthesis of natural products and biologically active substances.Metal catalysis plays an increasingly important role in these reactions, often allowing several stereocenters to be selectively created and integrated in the target molecules. Kobayashi and Jorgensen's handbook provides numerous examples of metal-catalyzed reactions, including [2+1], [3+2] and [4+2] cycloadditions. Important reactions such as carbo- and hetero-Diels-Alder, carbocyclic, cyclopropanation and 1,3-dipolar cycloaddition reactions are discussed. A large number of experimental procedures gives a concrete idea of the use of metal-catalyzed cycloaddition reactions in modern synthesis.The book is aimed at chemists in industry or academia, who want to effectively use cycloadditions in their work.
Pass: www.forumakademi.org
Handbook of Reagents for Organic Synthesis, Chiral Reagents for Asymmetric Synthesis Leo A. Paquette.Publisher: Wiley Number Of Pages: 582 Publication Date: 2003-08-15
Description: Derived from the renowned, Encyclopedia of Reagents for Organic Synthesis (EROS), the related editors have created a new handbook which focuses on chiral reagents used in asymmetric synthesis and is designed for the chemist at the This new handbook follows the same format as including an introduction and an alphabetical arrangement of the reagents. As chiral reagents are the key for the successful asymmetric synthesis, choosing the right reagents is essential, in this handy reference the editors give details on how to prepare, store and use the reagents as well as providing key reactions to demonstrate where reagents have been successfully used.
Description: Derived from the renowned, Encyclopedia of Reagents for Organic Synthesis (EROS), the related editors have created a new handbook which focuses on chiral reagents used in asymmetric synthesis and is designed for the chemist at the This new handbook follows the same format as including an introduction and an alphabetical arrangement of the reagents. As chiral reagents are the key for the successful asymmetric synthesis, choosing the right reagents is essential, in this handy reference the editors give details on how to prepare, store and use the reagents as well as providing key reactions to demonstrate where reagents have been successfully used.
Bioconjugate Techniques, Second Edition.Publisher: Academic Press
Number Of Pages: 1323
Publication Date: 2008-04-01
ISBN-10 / ASIN: 0123705010
ISBN-13 / EAN: 9780123705013
Binding: Paperback
Number Of Pages: 1323
Publication Date: 2008-04-01
ISBN-10 / ASIN: 0123705010
ISBN-13 / EAN: 9780123705013
Binding: Paperback
Handbook of Industrial Biocatalysis.Product Details
Hardcover: 616 pages Publisher: CRC; 1 edition(June 9, 2005) Language: English ISBN-10: 0824724232 ISBN-13: 978-0824724238 Product Dimensions: 8.5 x 6.1 x 0.6 inches Shipping Weight: 1.2 pounds http://rapidshare.com/files/23900903/HiBiCa.rar
Hardcover: 616 pages Publisher: CRC; 1 edition(June 9, 2005) Language: English ISBN-10: 0824724232 ISBN-13: 978-0824724238 Product Dimensions: 8.5 x 6.1 x 0.6 inches Shipping Weight: 1.2 pounds http://rapidshare.com/files/23900903/HiBiCa.rar
Monday, July 28, 2008
Your Library Requires These Bibles
Handbook of Solvents
Handbook of Chemistry
Handbook of Inorganic Chemicals
Handbook of Water Treatment
Hazardous Waste Handbook
Hazardous Chemicals Handbook
Handbook of Industrial Mixing
Handbook of Heterocyclic Chemistry
Analytical Chemistry Handbook
Solvent Recovery Handbook
Drug discovery Handbook
Handbook of Chiral Chemicals
Handbook of Drug Screening
The Clinical Use of Blood Handbook
Crystallization Technology Handbook
Handbook of Size Exclusion Chromatography
Handbook of Organic Solvent Properties
Handbook of Preperative Inorganic Chemistry
Handbook of Chemical Risk Assessment
Dean's Analytical Chemistry Handbook
Dean’s Hand Book Of Organic Chemistry
Handbook of Polymer Synthesis
Handbook of Chemistry
Handbook of Inorganic Chemicals
Handbook of Water Treatment
Hazardous Waste Handbook
Hazardous Chemicals Handbook
Handbook of Industrial Mixing
Handbook of Heterocyclic Chemistry
Analytical Chemistry Handbook
Solvent Recovery Handbook
Drug discovery Handbook
Handbook of Chiral Chemicals
Handbook of Drug Screening
The Clinical Use of Blood Handbook
Crystallization Technology Handbook
Handbook of Size Exclusion Chromatography
Handbook of Organic Solvent Properties
Handbook of Preperative Inorganic Chemistry
Handbook of Chemical Risk Assessment
Dean's Analytical Chemistry Handbook
Dean’s Hand Book Of Organic Chemistry
Handbook of Polymer Synthesis
Chemical Analysis: Modern Instrumentation Methods and Techniques 2nd ed.By Francis Rouessac, Annick Rouessac,Publisher: WileyNumber Of Pages: 600Publication Date: 2007-05-25Sales Rank: 509973ISBN / ASIN: 0470859032EAN: 9780470859032Binding: PaperbackManufacturer: WileyStudio: Wiley
The HPLC Solvent Guide.Book DescriptionThe HPLC Solvent Guide provides detailed coverage of all commonly used HPLC solvents used in a wide range of separations. High-performance liquid chromatography (HPLC) is a procedure for separating components from a mixture of chemical substances; a combination of separation, identification, and quantitative measurements. Solvent selection is perhaps the most commonly overlooked parameter in HPLC. Even the most experienced analytical chemist tends to select one of three familiar solvents. HPLC is a mature but substantial market, and one that Wiley reaches successfully and well.The HPLC list is established, and this second edition of a successful title… will build upon the success of the first. This is a revised and expanded edition in a field that is still growing into areas of analysis and methods.
Guidance For Industry Bio-Analytical ValidationBook DescriptionThe information in this guidance generally applies to bioanalytical procedures such as gas chromatography (GC), high-pressure liquid chromatography (LC), combined GC and LC massspectrometric (MS) procedures such as LC-MS, LC-MS-MS, GC-MS, and GC-MS-MS performed for the quantitative determination of drugs and/or metabolites in biological matricessuch as blood, serum, plasma, or urine. This guidance also applies to other bioanalytical methods, such as immunological and microbiological procedures, and to other biological matrices, such as tissue and skin samples. This guidance provides assistance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements indeveloping bioanalytical method validation information used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies requiring pharmacokinetic (PK) evaluation. This guidance also applies to bioanalytical methods used for non-human harmacology/toxicology studies and preclinical studies. For studies related to the veterinary drug approval process, this guidance applies only to blood and urine BA, BE, and PK studies.This guidance provides general recommendations for bioanalytical method validation. Therecommendations can be adjusted or modified depending on the specific type of analytical method used.
Troubleshooting and Maintenance Guide for Gas Chromatographers .This fourth edition of the classic guide for every user of gas chromatographic instrumentation is now updated to include such new topics as fast GC using narrow, short columns, electronic pressure control, and basic aspects of quantitative gas chromatography. The author shares his many years of experience in technical support for gas chromatography users, addressing the most common problems, questions and misconceptions in capillary gas chromatography. He structures and presents the material in a concise and practical manner, suitable even for the most inexperienced user without any detailed knowledge of chemistry or chromatography. For lab technicians in chemistry, analytical, food, medicinal and environmental chemists, pharmaceutists.
http://rapidshare.com/files/92832921/Tblshoot_guide_GC.zip
Chemical Separations: Principles, Techniques and Experiments .Principles, Techniques and Experiments By Clifton E. MeloanPublisher: Wiley-Interscience Number Of Pages: 768 Publication Date: 1999-10-06 Book Description: Performing effective chemical separations-a step-by-step guide to the most commonly used techniques.How do experienced analysts go about making a chemical separation work? Through precise, detailed coverage of the principles, equipment, and techniques involved, this combination laboratory manual and reference source gives readers a working knowledge of an impressive array of separation methods. In forty-two chapters, it explores all major categories of separation, including those involving phase changes, extraction, chromatography, resins, electric fields, flotation, membranes, and miscellaneous techniques.With an emphasis on everyday practice rather than theory, Chemical Separations explains the principles and parameters of these methods with a minimum of mathematics, while providing 59 specific to demonstrate proper procedures. Drawn from well-known commercial and academic laboratories and approved by national standard-setting organizations, these experiments feature step-by-step protocols for each separation scheme, precise instructions on setting up the apparatus, and helpful checklists for essential chemicals and supplies. With Chemical Separations as their guide, analysts and newcomers to chemical analysis will learn how to obtain quality analysis using commercial products, natural samples, and proven real-world laboratory techniques.
Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists(Paperback).Product Details
Paperback: 337 pages Publisher: Churchill Livingstone(December 1999) Language: English ISBN-10: 0443059861 ISBN-13: 978-0443059865 Product Dimensions: 9.5 x 7.4 x 0.8 inches Shipping Weight: 1.8 pounds Download from here
Laboratory manual for the physico-chemical analysis of soil, water and plant .Chaturvedi, R.K. and K. Sankar. 2006. Laboratory manual for the physico-chemical analysis of soil, water and plant. Wildlife Institute of India, Dehradun. Pp 97.
Chromatographic Detectors (Chromatographic Science)
By Raymond P.W. ScottPublisher: CRC
Number Of Pages: 536 Publication Date: 1996-07-17 http://rapidshare.com/files/4446418/chromatodetectors.rar
Password: www.AvaxHome.ru
Chromatography: Concepts and ContrastsBy James M. Miller
Publisher: Wiley-Interscience
Number Of Pages: 320 Publication Date: 1988-01-04 http://rapidshare.com/files/9493167/Chromatography_-_Concepts_and_Contrasts_0471848212.rar
http://rapidshare.de/files/15916734/H014782.djvu
http://mihd.net/uqintm/__4e28b02__.html
Current Practice of Gas Chromatography-Mass Spectrometry
By Wilfried M.A. Niessen
Publisher: CRC Number Of Pages: 528 Publication Date: 2001-04-04 http://rapidshare.com/files/68453692/0824704738.rar__4428b02__via_gigapedia.info__.html
PASSWORD: gigapedia
http://mihd.net/frgjdz/__3228b02__.html
High-Performance Gradient Elution:
The Practical Application of the Linear-Solvent-Strength Model
By Lloyd R. Snyder, John W. DolanPublisher: Wiley-Interscience Number Of Pages: 496 Publication Date: 2006-12-11
http://rapidshare.com/files/73968891/HPGradient_Elution.zip
http://rapidshare.com/files/73782612/High-Performance_Gradient_Elution.rar
High-Performance Liquid Chromatography: Advances and PerspectivesBy Csaba HorvathPublisher: Academic Pr Number Of Pages: 341 Publication Date: 1980-06 http://rapidshare.com/files/6710906/Horvath.pdf
Handbook of Ion Chromatography.Product Details
Hardcover: 931 pages
Publisher: Wiley-VCH; 3 Rev Upd edition (January 4, 2005)
Language: English
ISBN-10: 3527287019
ISBN-13: 978-3527287017
Product Dimensions: 9.9 x 7.2 x 2.4 inches
Book DescriptionThe third edition of this highly successful and established handbook has been completely revised and considerably extended, making it unrivaled in the timeliness and comprehensiveness of the information presented. This new edition runs to two volumes, with added chapters or sections covering:- New and important applications of ion chromatography in the life sciences, such as the analysis of proteins, nucleic acids, amino acids or carbohydrates. - New instrumentation that meets the demand for miniaturization and reduced analysis times. - Coupling of ion chromatography to mass-spectrometric or inductively coupled plasma detectors- Validation of ion-chromatographic methods, which is important for quality assuranceThe author has played a major role in the development of ion chromatography and – alongside his industrial post -- has been appointed as visiting professor at the University of Innsbruck, one of the prominent centers of chromatography research in the world.
Hardcover: 931 pages
Publisher: Wiley-VCH; 3 Rev Upd edition (January 4, 2005)
Language: English
ISBN-10: 3527287019
ISBN-13: 978-3527287017
Product Dimensions: 9.9 x 7.2 x 2.4 inches
Book DescriptionThe third edition of this highly successful and established handbook has been completely revised and considerably extended, making it unrivaled in the timeliness and comprehensiveness of the information presented. This new edition runs to two volumes, with added chapters or sections covering:- New and important applications of ion chromatography in the life sciences, such as the analysis of proteins, nucleic acids, amino acids or carbohydrates. - New instrumentation that meets the demand for miniaturization and reduced analysis times. - Coupling of ion chromatography to mass-spectrometric or inductively coupled plasma detectors- Validation of ion-chromatographic methods, which is important for quality assuranceThe author has played a major role in the development of ion chromatography and – alongside his industrial post -- has been appointed as visiting professor at the University of Innsbruck, one of the prominent centers of chromatography research in the world.
Biochromatography: Theory and Practice.Publisher: CRC
Number Of Pages: 526
Publication Date: 2002-02-14
ISBN-10 / ASIN: 0415269032
ISBN-13 / EAN: 9780415269032
Binding: Hardcover
Product Description: The field of bioseparation, and biochromatography in particular, is advancing very rapidly as our knowledge of the properties of molecules and atomic forces increases. This volume covers the basic principles of biochromatography in detail. It assesses different techniques and includes a large number of applications, providing the reader with a multidisciplinary perspective that gives the insight to master the many chromatographic methods. Biochromatography: Theory and Practice is a valuable tool for graduate and research scientists, technicians, engineers and teachers in a range of fields including biochemistry, biotechnology, biorecognition and chromatography.
Number Of Pages: 526
Publication Date: 2002-02-14
ISBN-10 / ASIN: 0415269032
ISBN-13 / EAN: 9780415269032
Binding: Hardcover
Product Description: The field of bioseparation, and biochromatography in particular, is advancing very rapidly as our knowledge of the properties of molecules and atomic forces increases. This volume covers the basic principles of biochromatography in detail. It assesses different techniques and includes a large number of applications, providing the reader with a multidisciplinary perspective that gives the insight to master the many chromatographic methods. Biochromatography: Theory and Practice is a valuable tool for graduate and research scientists, technicians, engineers and teachers in a range of fields including biochemistry, biotechnology, biorecognition and chromatography.
Thin-Layer Chromatography, Fourth Edition (Chromatographic Science)By Bernard Fried, Joseph ShermaPublisher: CRC
Number Of Pages: 512
Publication Date: 1999-01-04
ISBN-10 / ASIN: 0824702220
ISBN-13 / EAN: 9780824702229
Binding: Hardcover
Product Description:
The fourth edition of this work emphasizes the general practices and instrumentation involving TLC and HPTLC, as well as their applications based on compound types, while providing an understanding of the underlying theory necessary for optimizing these techniques. The book details up-to-date qualitative and quantitative densitometric experiments on organic dyes, lipids, antibiotics, pharmaceuticals, organic acids, insecticides, and more.
http://rapidshare.com/files/114139226/0824742087.zip
Liquid Chromatography Mass Spectrometry
http://rapidshare.com/files/67565003...ectrometry.pdf
Wiley Liquid Chromatography Mass Spectrometry An Introduction 2003 http://rapidshare.com/files/67610837...ction_2003.pdf
Capillary Gas Adsorption Chromatography.Publisher: Wiley-VCH
Number Of Pages: 330
Publication Date: 1998-12-23
ISBN-10 / ASIN: 3527296751
ISBN-13 / EAN: 9783527296750
Binding: Hardcover
Quadrupole Ion Trap Mass Spectrometry , 2nd Edition .Product Details
Hardcover: 392 pages
Publisher: Wiley-Interscience; 2 edition (August 23, 2005)
Language: English
ISBN-10: 0471488887
ISBN-13: 978-0471488880 Editorial ReviewsReview"…[the authors] brighten up even the least interesting, and most challenging sections...[the book]...will be required reading for my graduate students." (Journal of the American Society for Mass Spectrometry, May 2006) "The authors have done a great job…providing invaluable information on a complex topic in a single volume…this is an important, comprehensive, and well-written description." (CHOICE, January 2006)
Hardcover: 392 pages
Publisher: Wiley-Interscience; 2 edition (August 23, 2005)
Language: English
ISBN-10: 0471488887
ISBN-13: 978-0471488880 Editorial ReviewsReview"…[the authors] brighten up even the least interesting, and most challenging sections...[the book]...will be required reading for my graduate students." (Journal of the American Society for Mass Spectrometry, May 2006) "The authors have done a great job…providing invaluable information on a complex topic in a single volume…this is an important, comprehensive, and well-written description." (CHOICE, January 2006)
Fundamentals of Analytical Toxicology.Publisher: Wiley-Interscience
Number Of Pages: 544
Publication Date: 2008-03-21
ISBN-10 / ASIN: 0470319356
ISBN-13 / EAN: 9780470319352
Binding: Paperback
Number Of Pages: 544
Publication Date: 2008-03-21
ISBN-10 / ASIN: 0470319356
ISBN-13 / EAN: 9780470319352
Binding: Paperback
Split and Splitless Injection for Quantitative Gas Chromatography: Concepts, Processes, Practical Guidelines, Sources of Error (4th, Completely Revised Edition) by Konrad Grob.Publisher: Wiley-VCH Number Of Pages: 480 Publication Date: 2001-04-06 ISBN-10 / ASIN: 3527298797 Description: This comprehensive and unique handbook of split and splitless injection techniques has been completely revised and updated. This new edition offers: New insights concerning sample evaporation in the injector Information about matrix effects A new chapter on injector designThe real processes within the injector are for the first time visualized and explained by the CD-ROM included in the book. Furthermore the reader will understand the concepts of injection techniques and get a knowledge of the sources of error. The handbook also includes many practical guidelines. http://rapidshare.com/files/18043406/spli_splitless_injection_quantitative_gc.rar
Practical High-Performance Liquid Chromatography, 4th Edn.pdf.http://rapidshare.com/files/130875392/Practical_High-Performance_Liquid_Chromatography__4th_Edn.pdf.rar
Azoles, Antifungal Active Substances: Syntheses and UsesL. Zirngibl.Publisher: Wiley-VCH Verlag GmbH Number Of Pages: 300 Publication Date: 1998-05 Description: Azoles are central ingredients in many drugs. They play an important role in the fight against skin deseases and the secondary symptoms of AIDS. They are also used in the protection of plants and in industry (leather, wool). The rapid development in this field affords a comprehensive handbook about their uses and applications.The book covers the last 15 years of development of the title substances from a synthetic organic viewpoint based on over 2700 references (including 1350 patents) until October 1997. The author shows structure-activity relationships, activities and applications. The work will become an indispensable planning guide for researchers in the
pharmaceutical industry and at universities.
Traceability in Chemical MeasurementBook Description:
Metrological traceability of chemical measurement results means the establishment of a relation to metrological stated references through an unbroken chain of comparisons. This volume collects 56 outstanding papers on the topic, mostly published in the period 2000-2003 in the journal "Accreditation and Quality Assurance". They provide the latest understanding, and possibly the rationale why it is important to integrate the concept of metrological traceability including suitable measurement standards such as certified reference materials, into the standard measurement procedures of every analytical laboratory. In addition, this anthology considers the benefits to both the analyticallaboratory and the user of the measurement results.Publisher: SpringerNumber Of Pages: 281Publication Date: 2005-01-12Sales Rank: 254646ISBN / ASIN: 3540439897EAN: 9783540439899Binding: HardcoverManufacturer: SpringerStudio: Springer
Sulfuric Acid ManufactureBy William G.I. Davenport, Matthew King,
* Publisher: Elsevier Science* Number Of Pages: 425* Publication Date: 2005-12-17* ISBN / ASIN: 0080444288Book Description:More sulfuric acid is produced every year than any other chemical. It has a wide range of uses including phosphate fertilizer production, explosives, glue, wood preservatives, and lead-acid batteries. It is also a particularily corrosive and dangerous acid, with extreme environmental and health hazards if not manufactured, used, and regulated properly.Sulfuric Acid Manufacture: Analysis, Control and Optimization keeps the important topics of safety and regulation at the forefront as it overviews and analyzes the process of sulfuric acid manufacture.The first nine chapters focus on the chemical plant processes involved in industrial acidmaking, with considerable data input from the authors' industrial colleagues. The last 15 chapters are dedicated to the mathematical analysis of acidmaking. Both Authors bring years of hands-on knowledge and experience to the work, making it an exceptional reference for anyone involved in sulfuric acid research and/or manufacture. * Only book to examine the processes of sulfuric acid manufacture from an industrial plant standpoint as well as mathematical. * Draws on the industrial connections of the authors, through their years of hands-on experience in sulfuric acid manufacture. * A considerable amount of industrial plant data is presented to support the text.pdf. no pass, 13146 KB
Sodium Sulfate : Handbook of Deposits, Processing & UseBy Donald E. Garrett
* Publisher: Academic Press* Number Of Pages: 365* Publication Date: 2001-07-16* ISBN / ASIN: 0122761510Book Description: Sodium Sulfate: Handbook of Deposits, Processing, Properties, and Use will be the authoritative and up-to-date distillation of all that is known about naturally occurring sodium sulfate, detailed information on formation, worldwide deposits, processing technologies, and usage over time. Garrett provides a comprehensive overview of sodium sulfate from deposit formation, through processing technologies and usage. Garrett's reference addresses the need for a comprehensive handbook on this industrial mineral. Dr. Garrett's unique chemical engineering background and flair for history have allowed him to integrate information about the major borate deposits in the world with a discussion of their sociopolitical impact throughout the ages. The scope and detail of the book are unequaled in the literature. First comprehensive reference on naturally occuring sodium sulfates, their chemistry, deposits, and applications Author is a recognised authority and author on the chemical engineering aspects of saline minerals, borates, soda ash, and potashno pass, pdf, 29129 KB
Safety in Academic Chemistry Laboratories, 7th edition Volume 1Accident Prevention for College and University Students.Publisher Amer Chemical Society Number Of Pages:40 Publication Date:2003-06-30
Volum2Direct
Writing Reaction Mechanisms in Organic Chemistry(Advanced Organic Chemistry).
Audrey Miller, Philippa H. Solomon, “Writing Reaction Mechanisms in Organic Chemistry (Advanced Organic Chemistry)”Academic Press; 2 edition ISBN-10: 0124967124 471 pages PDF 11,5 Mb
“This is an excellent text that should be a requirement for all students entering the organic chemistry profession. Improvements will simply make a good thing even better….The level of difficulty is appropriate for graduate students and advanced undergraduates….The overall organization is superb….The ‘hints’ were amazingly on target for answering some of the questions that repeatedly come up with students.”
“This is an excellent text that should be a requirement for all students entering the organic chemistry profession. Improvements will simply make a good thing even better….The level of difficulty is appropriate for graduate students and advanced undergraduates….The overall organization is superb….The ‘hints’ were amazingly on target for answering some of the questions that repeatedly come up with students.”
Organophosphorus Reagents: A Practical Approach in Chemistry.Organophosphorus Reagents: A Practical Approach in Chemistry (The Practical Approach in Chemistry Series)By Patrick J. MurphyPublisher: Oxford University Press, USA Number Of Pages: 288 Publication Date: 2004-09-30.
Practical Skills in Chemistry.Publisher: Prentice-Hall
Number Of Pages: 376
Publication Date: 2001-11-06
ISBN-10 / ASIN: 013028002X
ISBN-13 / EAN: 9780130280022
Binding: Paperback
Number Of Pages: 376
Publication Date: 2001-11-06
ISBN-10 / ASIN: 013028002X
ISBN-13 / EAN: 9780130280022
Binding: Paperback
Chemistry of the Carbonyl GroupStuart Warren.Publisher: John Wiley and Sons .Number Of Pages: 128 Publication Date: 1974-01-01 A program for first and second year undergraduates in organic chemistry. This programmed text is written so that the student can teach himself the principles of carbonyl chemistry starting from the simplest addition reactions and ending with highly sophisticated syntheses. The approach is mechanistic and the book attempts to stress the logic behind carbonyl chemistry and to show how the basic principles applied in this field are also relevant in other areas of organic chemistry.The program may therefore be used as a text in the teaching of the principles of organic reaction mechanisms in general. http://rapidshare.com/files/9247341/...0471921041.pdf
Functional Organic Materials: Syntheses, Strategies and ApplicationsThomas J. J. Müller, Uwe H. F. Bunz.Publisher: Wiley-VCH Number Of Pages: 612 Publication Date: 2007-03-26 BookDescription: This timely overview of the syntheses for functional pi-systems focuses on target molecules that have shown interesting properties as materials or models in physics, biology and chemistry. The unique concept allows readers to select the right synthetic strategy for success, making it invaluable for a number of industrial applications.A "must have" for everyone working in this new and rapidly expanding field.
Pass Word: tFFUNOMV1.rar
Advanced Applications of NMR to Organometallic ChemistryMarcel Gielen, Rudolph Willem, Bernd Wrackmeyer.Publisher: Wiley Number Of Pages: 396 Publication Date: 1996-12 Description: This new series offers leading contributions by well known chemists reviewing the state-of-the-art of this wide research area. Physical Organometallic Chemistry aims to develop new insights and to promote novel interest and investigations applicable to organometallic chemistry. NMR spectroscopy has had a considerable impact on many fields of chemistry, although it has served organometallic chemistry mainly on a routine level. In a collection of reviews, leading chemists provide an insight into the scope of applications and uncover the potential of this technique for organometallic chemists. Advanced Applications of NMR to Organometallic Chemistry.
Thiophenes (Best Synthetic Methods)Salo Gronowitz, Anna-Britta HörnfeldtPublisher: Academic Press Number Of Pages: 986 Publication Date: 2004-07-01 Description There is a vast and often bewildering array of synthetic methods and reagents available to organic chemists today. The Best Synthetic Methods series allows any scientist who is interested in the chemical transformations of molecules to choose between all the alternatives and assess their real advantages and limitations. With the emphasis on laboratory use, these volumes represent a comprehensive and practical guide to modern synthetic organic chemistry. This book is the product of the authors many years practical experience and reading of the original literature. It contains a valuable distillation and critical evaluation of the Best Synthetic Methods for the formation and reaction of thiophenes (five membered heterocycles containing a ring sulfur) or polymers containing a thiophene functionality (thienyls). A brief review of each area is provided, but the emphasis in all cases is on describing efficient practical methods to effect the transformations described. The reader can therefore use this book to rapidly review and select the best methods of performing a synthetic conversion to create or modify a specifically substituted thiophene. Although this book contains many references to the original literature, the large number of experimental recipes enables the user to prepare a thiophene derivative without access to the original literature. These features make the handbook especially useful for physicists working in material sciences and organic/pharmaceutical chemists, who rapidly want to find out the availability of (or how to make) a specific thiophene.
New Methodologies and Techniques for a Sustainable Organic Chemistry: Sustainable Developments in a Secure Environment (NeMeTOC) (NATO Science Series II.Product Details
Hardcover: 338 pages
Publisher: Springer; 1 edition (May 200
Language: English
ISBN-10: 1402067917.
Hardcover: 338 pages
Publisher: Springer; 1 edition (May 200
Language: English
ISBN-10: 1402067917.
Amino Group Chemistry: From Synthesis to the Life Sciences.Amino Group Chemistry: From Synthesis to the Life Sciences
By Alfredo Ricci
Publisher: Wiley-VCH
Number Of Pages: 408
Publication Date: 2008-01-28
ISBN-10 / ASIN: 3527317414
ISBN-13 / EAN: 9783527317417
Binding: Hardcover
By Alfredo Ricci
Publisher: Wiley-VCH
Number Of Pages: 408
Publication Date: 2008-01-28
ISBN-10 / ASIN: 3527317414
ISBN-13 / EAN: 9783527317417
Binding: Hardcover
Classics in total synthesis By K. C. Nicolaou E. J. Sorensen. Publisher: Wiley-VCH Number Of Pages: 821
Publication Date: 1996-12-16
Description: This book is a must for every synthetic chemist. With didactic skill and clarity, K. C. Nicolaou and E. Sorensen present the most remarkable and ingenious total syntheses from outstanding synthetic organic chemists.To make the complex strategies more accessible, especially to the novice, each total synthesis is analyzed retrosynthetically. The authors then carefully explain each synthetic step and give hints on alternative methods and potential pitfalls. Numerous references to useful reviews and the original literature make this book an indispensable source of further information.Special emphasis is placed on the skillful use of graphics and schemes: Retrosynthetic analyses, reaction sequences, and stereochemically crucial steps are presented in boxed sections within the text. For easy reference, key intermediates are also shown in the margins.
Description: This book is a must for every synthetic chemist. With didactic skill and clarity, K. C. Nicolaou and E. Sorensen present the most remarkable and ingenious total syntheses from outstanding synthetic organic chemists.To make the complex strategies more accessible, especially to the novice, each total synthesis is analyzed retrosynthetically. The authors then carefully explain each synthetic step and give hints on alternative methods and potential pitfalls. Numerous references to useful reviews and the original literature make this book an indispensable source of further information.Special emphasis is placed on the skillful use of graphics and schemes: Retrosynthetic analyses, reaction sequences, and stereochemically crucial steps are presented in boxed sections within the text. For easy reference, key intermediates are also shown in the margins.
http://rapidshare.com/files/11398226/Wiley_.Classics.in.Total.Synthesis._1996_._3527292845_.rar.html
Catalytic Heterofunctionalization by Antonio Togni (Editor), Hansjörg Grützmacher (Editor), Hans-Jorg Grutzmacher.Product DetailsHardcover: 450 pages Publisher: Wiley-VCH; 1st edition(January 15, 2001) Language: English ISBN-10: 3527302344 ISBN-13: 978-3527302345 Product Dimensions: 9.8 x 6.9 x 0.9 inches
Excel 2007 for Scientists and Engineers by Dr. Gerard VerschuurenProduct DetailsPaperback: 258 pages Publisher: Holy Macro! Books; Second edition edition (April 1, 2008) Language: English ISBN-10: 1932802355 ISBN-13: 978-1932802351 Product Dimensions: 8.9 x 7.5 x 0.7 inches
Know Your Pharma Industry(Part-II)
II Patent:
a. Definition :- An exclusive right given to the innovator by the government for certain period to protect his innovation from others.
[or]
It is defined as a monopoly right given for an invention by the government to the inventor for certain period.
Under united states law, four types of patents issued.
1. Utility patents 2. Design patents 3. Plant patents 4. Provisional Patents:
1. Utility patents:- These patents covers processes, machines, manufacture or composition of matter and new and useful improvements.
Process: Method of treating cancer, use of a known chemical agent which was not known to have herbicidal properties. Method of nondestructive testing of composite materials .
Machines: A device to detect estrus in cow, A particle board blender, An electronic animal hoof force detection system.
Manufacture: Mutated proteins & Monoclonal Anybodies
Composition of matter: A physical utility where the substance itself is the important element , a new chemical compound, veterinary antibodies pure form of naturally occurring substance .
Improvements:- Improvement of above paten table matter if it is distinct.
2. Design patents :- US law provides for design patent protection for the appearance or ornamental design of a article. The form of a design patent is 14 years.
3. Plant patents;- Plant utility patent protection & available for biotechnology, processes, genes, seeds, plant parts, cultivates and hybrids. Plant protection is available under the plant patent act for a sexually reproduced plants only Ex: Apricot trees, cheery trees bent grass seed.
4. Provisional patents:- Provisional, can provide up to twelve months to further develop the invention, determine marketability acquire funding or capital, seek licensing or manufacturing. There are four 4 types of paragraphs in ANDA submission:1.Paragraph I: This is for applying fresh patent, there shouldn’t be any same patent.2. Paragraph II: This is to do and follow the existing patent up to its expiring.3. Paragraph III : This is the procedure to enter into the market” after expiring of patent
4. Paragraph IV: This is the procedure of challenging and showing that ‘The existing patent is non-infringing and invalidated.’
Intellectual property rights:- (IPR):- Responsibilities:-
Preparation of Dossier:-
Introduction, molecular formula, molecular structure, CAS number and chemical name.
Patent status, patent details & patent expiry.
Synthetic pathway:
Patent evaluation, literature collection.
Patent challenging paragraph IV
Infringing: - If the process is said to be infringing then it matching with that of prior act.
Non infringing: - If the process is said to be non infringing if it does not matching with prior act.
Prior act:- The information which is already disclosed or available.
Bio equivalence:- In all aspects strength and stability to be equivalent to that of innovator product. IPA: Indian patent act.
Patent: “A patent is a set of legal rights, that allows the inventor of a novel new or other wise useful invention to prevent others from making selling or even using the invention”
Intellectual properties :- Patents, Trademarks, copyrights, trade secrets, designs are forms of intellectual properties.
You have right to other intellectual prosperities without getting it registered with office or authority of government.
Patent has to be registered with patent office in order to on title you for protection. Importance of generics market.
Objective :
· Drug approval process for generics in us
· Role of us FDA in approving generics products
Hatch- waxman Act :
· Enacted by US Government in 1984.
· Legislated in response to growing concern over price of Drug spiraling out of control
· Gives rewards / incentives to generics companies who successfully challenge innovator patents
Introduction of TRIPS Agreement :
Trips : Trade related aspects of intellectual property rights
SALIENT FEATURES :
· First pronounced in year 1995
· Most of the countries are rignatovies to TRIPS
· Main objective is to bring in the system of uniform patent protection throughout the world.
· Sets certain minimum standards of patens legislation to be followed by all members countries.
· Most important condition required by TRIPS is “introduction product patent “
Patent law in India :
· Product patents
· Exclusive marketing Rights product patents
· Whether TRIPS regime will lead to increase in prices Drugs
· Patenting of traditional knowledge bases of indigenous need.
Aspects of FDA process:
In case of generic approval for new chemical entities innovator gets a minimum period of 5 years of exclusivity.
Term of protection given to inventor is 20 years standard from date of filing.
Minimum requirements for patent ability:- In order to grant a patent, paten office requires your application to fulfill 2 criteria’s, namely :
1. Novelty 2. Utility 3. Obviousness.
1. Novelty: Invention claiming must be new should not described by any publication before date of filling of application in patent office.
2. Utility: Composition /compound/formulation is applied for, & must have been shown to animal test.
Obviousness:
3. Efficacy in human being does not need to prove.
Patents listed in orange book can not be challenged by generic company up to 5 to 6 years of market exclusivity. If innovator files an NDA for a different chemical entity which is related to originally approve Drug, then the innovator will be awarded 3 years of marketing exclusivity.
II b
1.) Abbreviated New Drug Application: It is a formal application to market a new generic drug in USA.
ANDA: one the patent life of a successful drug inventor has expired, other companies are allowed to manufacture and cell generic versions of they till need FDA’s specific approval for these generic products, for which they submit on ANDA.
Abbreviated in the sense that there is no requirement to include clinical data to support safety or efficacy that has already demonstrated by drug inventor.
However the ANDA must demonstrate the bio equivalence of the proposed generic product to the innovator drug.
2. NDA: New Drug Application: - Formal application to market a new drug in USA.
INDA: - Investigational new drug application: Document submitted to FDA prior to commence clinical trials.
ANDA can only be filed by generic company in the last year of market inclusively, of the innovator.
II C
Definitions:
Process suitability:- The established capacity of the manufacturing process to produce effective and reproducibility of results consistently.
Accelerated testing: Studies designated to increase the rate of chemical degradation or physical change of an active drug substance or drug product by using storage conditions as a part of the formal definitive storage programme
Rejected material: Any material of item that has been determined to be unacceptable for the specified use.
Theoretical yield: The quantity that would be produced at any appropriate phase of manufacture processing or packing of a drug product based upon the quantity of components to be used, in the absence of any loss or error in actual production.
Actual yield: The quantity that is actually proceed at any appropriate phase of manufacture processing or packing of a drug product .
Percentage of theoretical yield: The ratio of actual yield to the theoretical yield .
Cross contamination:- An undesired introduction of one or more materials .
Shelf life or expiration dating period:- The time interval that a drug product is expected to remain within the approved shelf life specification provided that is stored under the conditions defined on the label.
In process testing: Testing performed during production to monitor & to adjust the process to ensure that the drug substance or intermediate conforms to its specifications.
Recovery:- The appropriate processing of materials to make them for further use.
Impurity: - Any component of a drug substance which is not the chemical entity defined as a new drug substance. OR Impurity is a foreign particle (material) which is present along with desired product.
Impurity profile:- A description o identified & unidentified impurities present in a new drug substance.
Potential impurity:- An impurity that theoretically can arise during manufacture or storage.
Extraneous impurities:- An impurity arising from any source extraneous in the manufacturing process, due to conformation.
Active pharmaceutical ingredients:- (API) : A substance produced by chemical synthesis, formation recovery from natural materials that is used as drug component labeled.
Pharmaceutical:- It is defined as a mixture of binding agents preservatives, micro cellulose coatings, execipients, packing material & other ingredients which cures side effects.
Starting material:- USFDA has defined as it is incorporated into the new drug substance as an important structure element, as it is commercially available.
Intermediate:- A material produced during the step of the synthesis of a new drug substance that undergoes further chemical transformation before it becomes a new drug substance.
Reagents:- A substance other than starting material, intermediate or solvent that is used in the manufacture of new drug substance.
Solvent: An in organic liquid used as a vehicle for the preparation solutions & suspensions in the synthesis of a new drug substance.
Pharmacopoeia:- It is the book containing a list of medicinal drugs and directions for the use.
Ligand:- An agent with a strong affinity to a metal ion.
Protocol:- It is the clear procedure & clear picture of experimental observations.
COD: Chemical oxygen demand:- The amount of oxygen needed to decompose a chemical in air.
Known impurity:_ structural conformation has been achieved.
Unknown impurity:- Structural conformation has not been achieved.
Infringing: - It the process is said to be infringing, than it is matching with prior art’s (prior art: Information which is already available/.disclosed
Non infringing:- If the process is said to be non-infringing if it doesn’t matches with that of the information which is already disclosed/ Available (prir art).
IIC
Abbreviations:
1. GATT : General Agreement an Trade & Tariff.
2. SBOA : Summary Based on Approval
3. EMR : Exclusive market vights.
4. IPA : Indian patent act.
5. ETP : Effluent treatment plant.
6. BOD : Biological oxygen demand.
7. COD : Chemical oxygen demand
8. TDS : Total dissolved salts/solids.
9. COC : Certificate of compliance.
10. USFDA: United states food and drug administration.
11. ISO : International organization for standardization.
12. LOD : Limit of detection.
13. LOQ : Limit of Quantification.
14. MSDS : Material safety data sheets
15. PDE : Permitted daily exposure.
16. TDI : Tolerable daily intake
17. ADI : Acceptable daily intake
18. TOC : Total organic carbon analysis
19. USP : United states pharmacopoeia
20. ACS : American chemical society.
21. RM : Regulatory market (regulations are stringent)
22. LRM : Less Regulatory market.
II C
Definition:
Reference standard:- It is a substance prepared to use as the standard in assay, identification purity.
LOD: Limit of detection: The lowest concentration of a analyte in a sample that can be detected, but not necessarily quantiated under the stated experimental conditions.
LOD: Signal to noise ration 2 & 3 is acceptable, 2 to 3 times of LOD=LOQ.
LOQ: Limit of quantification:- The lowest concentration of analyte in a sample , that can be determined with acceptable precision accuracy under the stated experimental conditions. Signal to noise ration 10.1 is acceptable.
Bulk density: The amount of drug substance present in unit volume.
Total dissolved solids: (TDS) : The determination of total amount of organic / in organic solids dissolved in a solution of unit volume.
Hazard: Defined as the potential for harmful effects.
Reactivity: It is the tendency of a substance to undergo chemical reaction.
In compatibles:- These are the substances which are reactive with each other.
Flash point: It is the lowest temperature of a substance at and above, which it can produce a fire or explosion, if 1. Vapor concentration of the substance is with in flammability range 2. If an ignition source is available.
Threshold limit value (TLV):- It is the maximum concentration of a chemical in air to which a person can be exposed for a certain period.
Flammability range:- Range between lower exposure limit where it can produce fir or explosion .
Fire Extinguishers types:
Fire A solids -------------------------- Water, sand & CO2
Fire B liquids ------------------------- Foam & CO2
Fire C gas ------------------------- Dry chemical powder (DCP)
Fire D&E Electrical ----------------- DCP & CO2
ISO : International Organization for Standardization.
ISO : 9000 - Certification.
ISO : 9001 - Quality, design, & manufacturing\
ISO : 9002 - Manufacturing & Quality
ISO : 14001 - Environmental safety
IID
Medical terms related to symptoms:
1. Analgesia: Loss of sensitivity to pain
2. Anesthesia: Loss of feeling
3. Ashyxia: Suffocation
4. Bronchitis Coughing, difficult in breathing
5. Bruise: Discolored spot
6. Cancer Abnormal tissue growth.
7. Conjunctivitis: Inflamed and reddened eyes
8. Convulsions Violent body spasms
9. Depression Decrease in activity
10. Dermatitis Reddened skin.
11. Dizziness Feeling faint
12. Drocusiness Falling asleep
13. Edema Swelling
14. Fatigue Tiredness
15. Gastroenteritis Inflammation of the stomach & intestine.
16. Hallucination: Strongly experienced false perception which has compulsive sense of realty object of current.
17. Hematuvia Blood in the urine
18. Hemorrhage Bleeding
19. Inflammation Swelling, redness, warmth
20. Insomnia Inability to obtain normal sleep.
21. Jaundice Yellow discolovation of skin or eyes
22. Lacrimaiton Excessive eye tearing
23. Malnutrition Inadequate diet
24. Nausea Feeling of need to vomit.
25. Palpitations Forceful heart beat.
26. Paralysis loss of ability to move limbs
27. Seizure: Convulsion
28. Spasm Convulsive muscular contraction
29. Swelling Enlargement
30. Tremors Shaking, trembling
31. Vertigo Feeling of whirling motion
a. Definition :- An exclusive right given to the innovator by the government for certain period to protect his innovation from others.
[or]
It is defined as a monopoly right given for an invention by the government to the inventor for certain period.
Under united states law, four types of patents issued.
1. Utility patents 2. Design patents 3. Plant patents 4. Provisional Patents:
1. Utility patents:- These patents covers processes, machines, manufacture or composition of matter and new and useful improvements.
Process: Method of treating cancer, use of a known chemical agent which was not known to have herbicidal properties. Method of nondestructive testing of composite materials .
Machines: A device to detect estrus in cow, A particle board blender, An electronic animal hoof force detection system.
Manufacture: Mutated proteins & Monoclonal Anybodies
Composition of matter: A physical utility where the substance itself is the important element , a new chemical compound, veterinary antibodies pure form of naturally occurring substance .
Improvements:- Improvement of above paten table matter if it is distinct.
2. Design patents :- US law provides for design patent protection for the appearance or ornamental design of a article. The form of a design patent is 14 years.
3. Plant patents;- Plant utility patent protection & available for biotechnology, processes, genes, seeds, plant parts, cultivates and hybrids. Plant protection is available under the plant patent act for a sexually reproduced plants only Ex: Apricot trees, cheery trees bent grass seed.
4. Provisional patents:- Provisional, can provide up to twelve months to further develop the invention, determine marketability acquire funding or capital, seek licensing or manufacturing. There are four 4 types of paragraphs in ANDA submission:1.Paragraph I: This is for applying fresh patent, there shouldn’t be any same patent.2. Paragraph II: This is to do and follow the existing patent up to its expiring.3. Paragraph III : This is the procedure to enter into the market” after expiring of patent
4. Paragraph IV: This is the procedure of challenging and showing that ‘The existing patent is non-infringing and invalidated.’
Intellectual property rights:- (IPR):- Responsibilities:-
Preparation of Dossier:-
Introduction, molecular formula, molecular structure, CAS number and chemical name.
Patent status, patent details & patent expiry.
Synthetic pathway:
Patent evaluation, literature collection.
Patent challenging paragraph IV
Infringing: - If the process is said to be infringing then it matching with that of prior act.
Non infringing: - If the process is said to be non infringing if it does not matching with prior act.
Prior act:- The information which is already disclosed or available.
Bio equivalence:- In all aspects strength and stability to be equivalent to that of innovator product. IPA: Indian patent act.
Patent: “A patent is a set of legal rights, that allows the inventor of a novel new or other wise useful invention to prevent others from making selling or even using the invention”
Intellectual properties :- Patents, Trademarks, copyrights, trade secrets, designs are forms of intellectual properties.
You have right to other intellectual prosperities without getting it registered with office or authority of government.
Patent has to be registered with patent office in order to on title you for protection. Importance of generics market.
Objective :
· Drug approval process for generics in us
· Role of us FDA in approving generics products
Hatch- waxman Act :
· Enacted by US Government in 1984.
· Legislated in response to growing concern over price of Drug spiraling out of control
· Gives rewards / incentives to generics companies who successfully challenge innovator patents
Introduction of TRIPS Agreement :
Trips : Trade related aspects of intellectual property rights
SALIENT FEATURES :
· First pronounced in year 1995
· Most of the countries are rignatovies to TRIPS
· Main objective is to bring in the system of uniform patent protection throughout the world.
· Sets certain minimum standards of patens legislation to be followed by all members countries.
· Most important condition required by TRIPS is “introduction product patent “
Patent law in India :
· Product patents
· Exclusive marketing Rights product patents
· Whether TRIPS regime will lead to increase in prices Drugs
· Patenting of traditional knowledge bases of indigenous need.
Aspects of FDA process:
In case of generic approval for new chemical entities innovator gets a minimum period of 5 years of exclusivity.
Term of protection given to inventor is 20 years standard from date of filing.
Minimum requirements for patent ability:- In order to grant a patent, paten office requires your application to fulfill 2 criteria’s, namely :
1. Novelty 2. Utility 3. Obviousness.
1. Novelty: Invention claiming must be new should not described by any publication before date of filling of application in patent office.
2. Utility: Composition /compound/formulation is applied for, & must have been shown to animal test.
Obviousness:
3. Efficacy in human being does not need to prove.
Patents listed in orange book can not be challenged by generic company up to 5 to 6 years of market exclusivity. If innovator files an NDA for a different chemical entity which is related to originally approve Drug, then the innovator will be awarded 3 years of marketing exclusivity.
II b
1.) Abbreviated New Drug Application: It is a formal application to market a new generic drug in USA.
ANDA: one the patent life of a successful drug inventor has expired, other companies are allowed to manufacture and cell generic versions of they till need FDA’s specific approval for these generic products, for which they submit on ANDA.
Abbreviated in the sense that there is no requirement to include clinical data to support safety or efficacy that has already demonstrated by drug inventor.
However the ANDA must demonstrate the bio equivalence of the proposed generic product to the innovator drug.
2. NDA: New Drug Application: - Formal application to market a new drug in USA.
INDA: - Investigational new drug application: Document submitted to FDA prior to commence clinical trials.
ANDA can only be filed by generic company in the last year of market inclusively, of the innovator.
II C
Definitions:
Process suitability:- The established capacity of the manufacturing process to produce effective and reproducibility of results consistently.
Accelerated testing: Studies designated to increase the rate of chemical degradation or physical change of an active drug substance or drug product by using storage conditions as a part of the formal definitive storage programme
Rejected material: Any material of item that has been determined to be unacceptable for the specified use.
Theoretical yield: The quantity that would be produced at any appropriate phase of manufacture processing or packing of a drug product based upon the quantity of components to be used, in the absence of any loss or error in actual production.
Actual yield: The quantity that is actually proceed at any appropriate phase of manufacture processing or packing of a drug product .
Percentage of theoretical yield: The ratio of actual yield to the theoretical yield .
Cross contamination:- An undesired introduction of one or more materials .
Shelf life or expiration dating period:- The time interval that a drug product is expected to remain within the approved shelf life specification provided that is stored under the conditions defined on the label.
In process testing: Testing performed during production to monitor & to adjust the process to ensure that the drug substance or intermediate conforms to its specifications.
Recovery:- The appropriate processing of materials to make them for further use.
Impurity: - Any component of a drug substance which is not the chemical entity defined as a new drug substance. OR Impurity is a foreign particle (material) which is present along with desired product.
Impurity profile:- A description o identified & unidentified impurities present in a new drug substance.
Potential impurity:- An impurity that theoretically can arise during manufacture or storage.
Extraneous impurities:- An impurity arising from any source extraneous in the manufacturing process, due to conformation.
Active pharmaceutical ingredients:- (API) : A substance produced by chemical synthesis, formation recovery from natural materials that is used as drug component labeled.
Pharmaceutical:- It is defined as a mixture of binding agents preservatives, micro cellulose coatings, execipients, packing material & other ingredients which cures side effects.
Starting material:- USFDA has defined as it is incorporated into the new drug substance as an important structure element, as it is commercially available.
Intermediate:- A material produced during the step of the synthesis of a new drug substance that undergoes further chemical transformation before it becomes a new drug substance.
Reagents:- A substance other than starting material, intermediate or solvent that is used in the manufacture of new drug substance.
Solvent: An in organic liquid used as a vehicle for the preparation solutions & suspensions in the synthesis of a new drug substance.
Pharmacopoeia:- It is the book containing a list of medicinal drugs and directions for the use.
Ligand:- An agent with a strong affinity to a metal ion.
Protocol:- It is the clear procedure & clear picture of experimental observations.
COD: Chemical oxygen demand:- The amount of oxygen needed to decompose a chemical in air.
Known impurity:_ structural conformation has been achieved.
Unknown impurity:- Structural conformation has not been achieved.
Infringing: - It the process is said to be infringing, than it is matching with prior art’s (prior art: Information which is already available/.disclosed
Non infringing:- If the process is said to be non-infringing if it doesn’t matches with that of the information which is already disclosed/ Available (prir art).
IIC
Abbreviations:
1. GATT : General Agreement an Trade & Tariff.
2. SBOA : Summary Based on Approval
3. EMR : Exclusive market vights.
4. IPA : Indian patent act.
5. ETP : Effluent treatment plant.
6. BOD : Biological oxygen demand.
7. COD : Chemical oxygen demand
8. TDS : Total dissolved salts/solids.
9. COC : Certificate of compliance.
10. USFDA: United states food and drug administration.
11. ISO : International organization for standardization.
12. LOD : Limit of detection.
13. LOQ : Limit of Quantification.
14. MSDS : Material safety data sheets
15. PDE : Permitted daily exposure.
16. TDI : Tolerable daily intake
17. ADI : Acceptable daily intake
18. TOC : Total organic carbon analysis
19. USP : United states pharmacopoeia
20. ACS : American chemical society.
21. RM : Regulatory market (regulations are stringent)
22. LRM : Less Regulatory market.
II C
Definition:
Reference standard:- It is a substance prepared to use as the standard in assay, identification purity.
LOD: Limit of detection: The lowest concentration of a analyte in a sample that can be detected, but not necessarily quantiated under the stated experimental conditions.
LOD: Signal to noise ration 2 & 3 is acceptable, 2 to 3 times of LOD=LOQ.
LOQ: Limit of quantification:- The lowest concentration of analyte in a sample , that can be determined with acceptable precision accuracy under the stated experimental conditions. Signal to noise ration 10.1 is acceptable.
Bulk density: The amount of drug substance present in unit volume.
Total dissolved solids: (TDS) : The determination of total amount of organic / in organic solids dissolved in a solution of unit volume.
Hazard: Defined as the potential for harmful effects.
Reactivity: It is the tendency of a substance to undergo chemical reaction.
In compatibles:- These are the substances which are reactive with each other.
Flash point: It is the lowest temperature of a substance at and above, which it can produce a fire or explosion, if 1. Vapor concentration of the substance is with in flammability range 2. If an ignition source is available.
Threshold limit value (TLV):- It is the maximum concentration of a chemical in air to which a person can be exposed for a certain period.
Flammability range:- Range between lower exposure limit where it can produce fir or explosion .
Fire Extinguishers types:
Fire A solids -------------------------- Water, sand & CO2
Fire B liquids ------------------------- Foam & CO2
Fire C gas ------------------------- Dry chemical powder (DCP)
Fire D&E Electrical ----------------- DCP & CO2
ISO : International Organization for Standardization.
ISO : 9000 - Certification.
ISO : 9001 - Quality, design, & manufacturing\
ISO : 9002 - Manufacturing & Quality
ISO : 14001 - Environmental safety
IID
Medical terms related to symptoms:
1. Analgesia: Loss of sensitivity to pain
2. Anesthesia: Loss of feeling
3. Ashyxia: Suffocation
4. Bronchitis Coughing, difficult in breathing
5. Bruise: Discolored spot
6. Cancer Abnormal tissue growth.
7. Conjunctivitis: Inflamed and reddened eyes
8. Convulsions Violent body spasms
9. Depression Decrease in activity
10. Dermatitis Reddened skin.
11. Dizziness Feeling faint
12. Drocusiness Falling asleep
13. Edema Swelling
14. Fatigue Tiredness
15. Gastroenteritis Inflammation of the stomach & intestine.
16. Hallucination: Strongly experienced false perception which has compulsive sense of realty object of current.
17. Hematuvia Blood in the urine
18. Hemorrhage Bleeding
19. Inflammation Swelling, redness, warmth
20. Insomnia Inability to obtain normal sleep.
21. Jaundice Yellow discolovation of skin or eyes
22. Lacrimaiton Excessive eye tearing
23. Malnutrition Inadequate diet
24. Nausea Feeling of need to vomit.
25. Palpitations Forceful heart beat.
26. Paralysis loss of ability to move limbs
27. Seizure: Convulsion
28. Spasm Convulsive muscular contraction
29. Swelling Enlargement
30. Tremors Shaking, trembling
31. Vertigo Feeling of whirling motion
Sunday, July 27, 2008
Analysis of Drug Impurities (Sheffield Analytical Chemistry Series)Analysis of Drug Impurities (Sheffield Analytical Chemistry Series)
By Richard J. Smith, Michael L. Webb
Publisher: Wiley-Blackwell
Number Of Pages: 288
Publication Date: 2007-05-04
ISBN-10 / ASIN: 1405133589
ISBN-13 / EAN: 9781405133586
Binding: Hardcover
The presence of impurities, even in small amounts, may affect the efficacy and safety of pharmaceuticals. The methods for detecting and controlling them are subject to continuous review and improvement. Characterisation of impurities is a crucial aspect of drug development and approval, and is central to quality control.
This book provides a source of reference on the techniques available for accurate identification and quantification of drug impurities, and it brings together all the relevant disciplines within one volume for the first time.
Liquids, Solutions, and Interfaces: From Classical Macroscopic Descriptions to Modern Microscopic Details (Topics in Analytical Chemistry)Liquids, Solutions, and Interfaces: From Classical Macroscopic Descriptions to Modern Microscopic Details (Topics in Analytical Chemistry)
By W. Ronald Fawcett
Publisher: Oxford University Press, USA
Number Of Pages: 638
Publication Date: 2004-07-01
ISBN-10 / ASIN: 0195094328
ISBN-13 / EAN: 9780195094329
Binding: Hardcover
Fifty years ago solution chemistry occupied a major fraction of physical chemistry textbooks, and dealt mainly with classical thermodynamics, phase equilibria, and non-equilibrium phenomena, especially those related to electrochemistry. Much has happened in the intervening period, with
tremendous advances in theory and the development of important new experimental techniques. This book brings the reader through the developments from classical macroscopic descriptions to more modern microscopic details.
How to Use Excel in Analytical Chemistry and in General Scientific Data Analysis.By Robert de Levie
Publisher: Cambridge University Press
Number Of Pages: 502
Publication Date: 2001-02-15
ISBN-10 / ASIN: 0521642825
ISBN-13 / EAN: 9780521642828
Binding: Hardcover
Spreadsheets provide one of the most easily learned routes to scientific computing. This book uses Excel®, the most powerful spreadsheet available, to explore and solve problems in general and chemical data analysis. It follows the usual sequence of college textbooks in analytical chemistry: statistics, chemical equilibria, pH calculations, titrations, and instrumental methods such as chromatography, spectrometry, and electroanalysis. The text contains many examples of data analysis, and uses spreadsheets for numerical simulations and testing analytical procedures. It treats modern data analysis methods such as linear and nonlinear least squares in great detail, as well as methods based on Fourier transformation. It shows how matrix methods can be powerful tools in data analysis, and how easily these are implemented on a spreadsheet. It describes in detail how to simulate chemical kinetics on a spreadsheet. It also introduces the reader to the use of VBA, the macro language of Microsoft Office, which lets the user import higher-level computer programs into the spreadsheet.
Modern Reduction MethodsModern Reduction Methods
By Pher Andersson, Ian Munslow
Publisher: Wiley-VCH
Number Of Pages: 522
Publication Date: 2008-05-23
ISBN-10 / ASIN: 3527318623
ISBN-13 / EAN: 9783527318629
Binding: Hardcover
With its comprehensive overview of modern reduction methods, this book features high quality contributions allowing readers to find reliable solutions quickly and easily.
The monograph treats the reduction of carbonyles, alkenes, imines and alkynes, as well as reductive aminations and cross and heck couplings, before finishing off with sections on kinetic resolutions and hydrogenolysis.
An indispensable lab companion for every chemist.
Heterogeneous Enantioselective Hydrogenation: Theory and Practice (Catalysis by Metal Complexes)By Evgenii Klabunovskii, Gerard V. Smith, Ágnes Zsigmond
Publisher: Springer
Number Of Pages: 304
Publication Date: 2006-10-05
ISBN-10 / ASIN: 1402042949
ISBN-13 / EAN: 9781402042942
Binding: Hardcover
Heterogeneous Enantioselective Hydrogenation: Theory and Practice reviews the development of enantioselective hydrogenation reaction catalysts. It looks at the first relatively ineffective catalysts right through to modern highly effective enantioselective catalytic systems, comparable in their efficiency to chiral metal complexes and enzymatic systems. The book begins with a summary of the first work on heterogeneous metal catalysts, which showed only the principal possibilities of enantioselective reactions. It then elaborates on metal catalysts which have enantioselectivities close to 100%. Finally, the practical utilization of chiral catalytic systems in processes of hydrogenation is described. The alpha- and beta-hydroxy carboxylic acid esters produced are precursors for manufacturing many synthones used for medicines as well as for monomers used for biodegradable polyesters, both of which have important practical applications.
The volume summarizes more than 800 scientific papers in the field of enantioselective catalytic hydrogenation reactions, mainly those using heterogeneous metal catalysts. It provides detailed explanations of special techniques for the preparation of effective dissymmetric catalysts which provide highly efficient catalytic systems. This book differs from previous publications by virtue of the recommendations for the practical utilization of recently described preparations of metal catalysts.
This book will be an invaluable resource to catalysis researchers as well as to those
http://rapidshare.com/files/121062800/heterogeneous.enantioselective.rar
Boronic Acids: Preparation and Applications in Organic Synthesis and Medicine.By Dennis G. Hall
Publisher: Wiley-VCH
Number Of Pages: 571
Publication Date: 2005-09-02
ISBN-10 / ASIN: 3527309918
ISBN-13 / EAN: 9783527309917
Binding: Hardcover
For the first time, the whole field of organoboronic acids is presented in one comprehensive handbook.
Professor Dennis Hall, a rising star within the community, covers all aspects of this important substance class, including applications in chemistry, biology and medicine.
Starting with an introduction to the structure, properties, and preparation of boronic acid derivatives, together with an overview of their reactions and applications, the book goes on to look at metal-catalyzed borylation of alkanes and arenas, coupling reactions and rhodium-catalyzed additions of boronic acids to alkenes and carbonyl compounds. There follows chapters on copper-promoted C-O and C-N cross-coupling of boronic acids, recent applications in organic synthesis, as well as alpha-haloalkylboronic esters in asymmetric synthesis. Later sections deal with cycloadditions, organoboronic acids, oxazaborolidines as asymmetric inducers, and boronic acid based receptors and sensors. The whole is rounded off with experimental procedures, making this invaluable reading for organic, catalytic and medicinal chemists, as well as those working in organometallics.
http://rapidshare.com/files/70286762/boronic_acids.pdf
http://rapidshare.com/files/70286834/BA-paaos.rar
Using Artificial Intelligence in Chemistry and Biology: A Practical Guide (Chapman & Hall/Crc Research No)Using Artificial Intelligence in Chemistry and Biology: A Practical Guide (Chapman & Hall/Crc Research No)
By Hugh Cartwright
Publisher: CRC
Number Of Pages: 360
Publication Date: 2008-05-05
ISBN-10 / ASIN: 0849384125
ISBN-13 / EAN: 9780849384127
Number Of Pages: 360
Publication Date: 2008-05-05
ISBN-10 / ASIN: 0849384125
ISBN-13 / EAN: 9780849384127
Binding: Hardcover
http://rapidshare.com/files/123120496/CART.rar
Title: Handbook Of Inorganic Chemicals
Description: The Handbook is an encyclopedia with Chemical Abstracts Service Registry Numbers (CASRN), formulas, synonyms, origins, uses, physical and thermochemical properties, preparation, uses, and reactions, analysis, and toxicity or hazards of some 2,000 industrially important inorganic chemicals, including elements and compounds.
Entries vary in length, depending on what is known about different compounds and probably indicating the relative industrial importance. Some entries include the history of the particular element or compound. The value of this work is in how it gathers information from a variety of sources and puts it in one volume...if readers need a quick reference book about the nature of the specific elements and inorganic compounds discussed in this book, this handbook will work well...Summing Up: Recommended.
# Hardcover: 1086 pages
# Publisher: McGraw-Hill Professional; 1 edition (November 20, 2002)
# Language: English
# ISBN-10: 0070494398
# ISBN-13: 978-0070494398
http://rapidshare.com/files/23122283/ Handbook_of_Inorganic_Chemicals__2003_.pdf
Air Monitoring for Toxic ExposuresAir Monitoring for Toxic Exposures
By Henry J. McDermott
Publisher: Wiley-Interscience
Number Of Pages: 688
Publication Date: 2004-09-21
ISBN-10 / ASIN: 0471454354
ISBN-13 / EAN: 9780471454359
Binding: Hardcover
Get the Latest from the Field
This book offers ready-to-use information for measuring a wide variety of airborne hazardous materials including chemicals, radon, and bioaerosols. It provides the latest procedures for air sampling, collecting biological and bulk samples, evaluating dermal exposures, and determining the advantages and limitations of a given air monitoring method.
http://rapidshare.com/files/124196265/0471454354.rar
Peroxides and Peroxide-Forming Compounds
by Donald E. Clark
excerpt from Chemical Health and Safety
Volume 8, Issue 5, September-October 2001
by Donald E. Clark
excerpt from Chemical Health and Safety
Volume 8, Issue 5, September-October 2001
http://rapidshare.com/files/94837281/Peroxides_and_Peroxide-Forming_Compounds.rar
New Techniques in Solid-State NMR (Topics in Current Chemistry)By Jacek Klinowski
Publisher: Springer
Number Of Pages: 358
Publication Date: 2005-05-23
ISBN-10 / ASIN: 3540221689
ISBN-13 / EAN: 9783540221685
Binding: Hardcover
Practical Statistics for Chemical Research
Practical Statistics for Chemical Research
By J.D. Hinchen
Publisher: Methuen young books
Number Of Pages: 96
Publication Date: 1969-03
ISBN-10 / ASIN: 0416466702
ISBN-13 / EAN: 9780416466706
Binding: Hardcover
Saturday, July 26, 2008
HPLC for Pharmaceutical Scientists By Yuri V. Kazakevich, Rosario LoBrutto
Publisher: Wiley-Interscience Number Of Pages: 1136 Publication Date: 2007-01-02 ISBN-10 / ASIN: 0471681628 ISBN-13 / EAN: 9780471681625 Binding: Hardcover.
Publisher: Wiley-Interscience Number Of Pages: 1136 Publication Date: 2007-01-02 ISBN-10 / ASIN: 0471681628 ISBN-13 / EAN: 9780471681625 Binding: Hardcover.
Handbook of Modern Pharmaceutical Analysis (Separation Science and Technology) By Satinder Ahuja, Stephen Scypinski
Publisher: Academic Press Number Of Pages: 600 Publication Date: 2001-07-27 ISBN-10 / ASIN: 0120455552 ISBN-13 / EAN: 9780120455553 Binding: Hardcover
Publisher: Academic Press Number Of Pages: 600 Publication Date: 2001-07-27 ISBN-10 / ASIN: 0120455552 ISBN-13 / EAN: 9780120455553 Binding: Hardcover
Microbial Contamination Control in the Pharmaceutical Industry (Drugs and the Pharmaceutical Sciences) By Luis Jimenez
Publisher: Informa Healthcare Number Of Pages: 310 Publication Date: 2004-08-30 ISBN-10 / ASIN: 082475753X ISBN-13 / EAN: 9780824757533 Binding: Hardcover
Publisher: Informa Healthcare Number Of Pages: 310 Publication Date: 2004-08-30 ISBN-10 / ASIN: 082475753X ISBN-13 / EAN: 9780824757533 Binding: Hardcover
Columns for Gas Chromatography: Performance and Selection Columns for Gas Chromatography: Performance and SelectionBy Eugene F., PhD Barry, Robert L., PhD GrobPublisher: Wiley-Interscience Number Of Pages: 298 Publication Date: 2007-04-13 ISBN-10 / ASIN: 0471740438 ISBN-13 / EAN: 9780471740438 Binding: Hardcover
Drug Bioavailability: Estimation of Solubility, Permeability, Absorption and Bioavailability (Methods and Principles in Medicinal Chemistry) by Han van de Waterbeemd, Raimund Mannhold, Hugo Kubinyi, Gerd Folkers, Hans Lennernas .Publisher: Wiley-VCH Number Of Pages: 602 Publication Date: 2003-08-08 ISBN-10 / ASIN: 352730438X ISBN-13 / EAN: 9783527304387 Binding: Hardcover
http://rapidshare.com/files/33949339/drug_bioavailability.rar
Careers with the Pharmaceutical Industry Careers with the Pharmaceutical IndustryBy Peter D. Stonier
Publisher: Wiley Number Of Pages: 376 Publication Date: 2003-05-23 ISBN-10 / ASIN: 0470843284 ISBN-13 / EAN: 9780470843284 Binding: Paperback
Publisher: Wiley Number Of Pages: 376 Publication Date: 2003-05-23 ISBN-10 / ASIN: 0470843284 ISBN-13 / EAN: 9780470843284 Binding: Paperback
Ion Chromatography, 2nd EditionIon Chromatography, 2EBy Joachim Weiss
Publisher: Vch Verlagsgesellschaft Mbh Number Of Pages: 466 Publication Date: 1994-12 ISBN-10 / ASIN: 3527286985 ISBN-13 / EAN: 9783527286980 Binding: Hardcover
Publisher: Vch Verlagsgesellschaft Mbh Number Of Pages: 466 Publication Date: 1994-12 ISBN-10 / ASIN: 3527286985 ISBN-13 / EAN: 9783527286980 Binding: Hardcover
Inductively Coupled Plasma Mass Spectroscopy: Practices and Techniques Inductively Coupled Plasma Mass Spectroscopy: Practices and TechniquesBy Howard E. Taylor
Publisher: Academic Press Number Of Pages: 293 Publication Date: 2000-01-15 ISBN-10 / ASIN: 0126838658 ISBN-13 / EAN: 9780126838657 Binding: Hardcover
Publisher: Academic Press Number Of Pages: 293 Publication Date: 2000-01-15 ISBN-10 / ASIN: 0126838658 ISBN-13 / EAN: 9780126838657 Binding: Hardcover
Handbook of Chiral Chemicals By David J. Ager
Publisher: CRC Number Of Pages: 384 Publication Date: 1999-01-04 ISBN-10 / ASIN: 0824710584 ISBN-13 / EAN: 9780824710583 Binding: Hardcover
Describes the problems associated with large, commercial-scale syntheses of chiral molecules and the relatively small number of reactions that can be used to achieve these syntheses. The book discusses commercially viable and still-developing methods of compound manufacture, and reviews the best-selling chiral compounds as of 1996.
Publisher: CRC Number Of Pages: 384 Publication Date: 1999-01-04 ISBN-10 / ASIN: 0824710584 ISBN-13 / EAN: 9780824710583 Binding: Hardcover
Describes the problems associated with large, commercial-scale syntheses of chiral molecules and the relatively small number of reactions that can be used to achieve these syntheses. The book discusses commercially viable and still-developing methods of compound manufacture, and reviews the best-selling chiral compounds as of 1996.
Handbook of Functionalized Organometallics: Applications in Synthesis Vol.1 & 2Publisher: Wiley-VCH Number Of Pages: 690 Publication Date: 2005-12-06 ISBN-10 / ASIN: 3527311319 ISBN-13 / EAN: 9783527311316 Binding: Hardcover.
Practical Problem Solving in HPLCPublisher: Wiley-VCH Number Of Pages: 180 Publication Date: 2000-05-19 Sales Rank: 690654 ISBN / ASIN: 3527298428 EAN: 9783527298426 Binding: Paperback Manufacturer: Wiley-VCH Studio: Wiley-VCH Average Rating: 4
Review: Good practical information
I have worked in the field on HPLC for many years but still found a lot of useful information and hints which I had never encountered before, like peak hight and area related to pump and injector problems. Not every item may be applicable to your specific field ou activity, but the book contains much good practical infromation for the beginner and advanced chromatographer as well. It is also not dependent on specific configurations or system models and, therefore, more timeless and useful for anyone.
I have worked in the field on HPLC for many years but still found a lot of useful information and hints which I had never encountered before, like peak hight and area related to pump and injector problems. Not every item may be applicable to your specific field ou activity, but the book contains much good practical infromation for the beginner and advanced chromatographer as well. It is also not dependent on specific configurations or system models and, therefore, more timeless and useful for anyone.
Competition Law and Patents:A Follow-on Innovation Perspective in the Biopharmaceutical Industry (New Horizons in Competition Law and Economics)
Competition Law and Patents: A Follow-on Innovation Perspective in the Biopharmaceutical Industry (New Horizons in Competition Law and Economics)By Irina Haracoglou
Publisher: Edward Elgar Publishing Number Of Pages: 251 Publication Date: 2008-03-31 ISBN-10 / ASIN: 1847205992
ISBN-13 / EAN: 9781847205995 Binding: Hardcover http://rapidshare.com/files/131051946/1847205992.rar
Monday, July 21, 2008
Know Your Pharma Industry(Part-I)
(a). DMF:
- Drug Master file.
Definition:- It is the document submitted voluntarily to regulatory authorities containing confidential information about process and facilities.
Requirements for DMF filing:-
1. Process: - a. Batch production Records b. In process controls c.
Intermediates
2. Facility address:
3. Production facilities: - a. Area b. Capacity.
4. Production Equipment:- a. GLR’S b. SSR’S c. Centrifuges d. Nutch, candy, leaf & Micro filters e. Driers like conevaccum drier tray drier f. Sifting equipments & bantom milling equipments etc.
5. Quality control: - a. In process control, b. Validation c. Specification and S T P’s of starting materials (Raw materials) intermediates, finished products etc.
6. Drug Description:- a. Chemical Abstract studies number b. Molecular formula c. Molecule structure d. Structural elucidation report etc.
7. Impurity profile:- a. process impurities b. Degradation impurities c. By products.
8. Analytical method validation:- HPLC, GC Analysis as per symphony.
9. Certificate of Analysis (COA) of reference standard, working standard and final product & their NMR & Mass.
10. List of major lab equipments :- a. Glass ware b. Stirrers c. Regulators d. Balances e. UV chambers f. Oven g. Autoclave h. MR apparatus i. Buchi Rotavapour systems k. high vacuum pumps & Diaphram pump etc.
11. Ware house facility Description:- Storage conditions
12. Organization chart:- Key persons Information
13. Production flow sheet or plant layout:-
14. Scheme process flow sheet & process Description:- Commercially availability of starting materials to total BPR.
15. Complaints filing:
16. Environment Assessment: SH&E package.
17. Annexcires BPR’s & Product labels:-
DMF Submission in Europe contains two parts.
Open part
Closed part
1. Open part:- (or) Applicant part:-
Nomenclature , structure and general properties like MR, solubility, Description & polymorphism.
Synthetic route chemical pathway.
Structural elucidation.
Impurity write up & impurity profile
Stability write up.
Control of active substance, final product specifications, COA and MOA, validation.
Reference standard : preparation & COA.
Container close system:- Closing & reading spec’s STP’s COA.
Manufacture:- Address.
2. Closed part or Aim restricted part:- API manufacture.
Address
Process validation or evaluation, process description & process control.
Specifications & STP’s of raw materials, intermediates, in process control & finished products.
DMF filing should be done by regulatory affairs.
DMF filing is compulsory for USFDA.
Regulatory affairs:- Responsibilities:
1. DMF filing \
2. Customer requirement
3. External affairs
4. As per regulatory requirements US, Europe & ROW
Drug master file is a reference source that provides confidential information not available to drug product manufacturers about the specifications, process and components used in the manufacturing, processing & packaging of drug meant for human use.
The submission of drug master file is not required by law & FDA regulation. A DMF is submitted slowly at the discretion of the holder. The information constricted in the DMF may be used to support on ‘IND, NDA & ANDA or another DMF or amendments and supplements to any of these.
A DMF is not a substitute for an IND, NDA, ANDA. It is not approved or disapproved. Technical contents of a DMF are revived only in connection with the review of an IND, NDA & ANDA.
Ib
US FDA Inspections.
Drug Inspections
Drug firms
New drugs
Manufacture of API and finished
Investigational new drugs
Product
Antibioties
Contract packages
Prescription drugs
Contract laboratories
Non perception drugs etc
Distributors, brokers & ware houses.
Types of Inspections: 1. GMP inspections 2. Pre-Approval inspections 3. Post –approval inspections 4. Other consumer complaints, recalls, drug quality reporting system etc.
Purpose of Inspections:
1. To ensure that production and control procedures include a reasonable predictions to ensure the identity, strength, quality & purity of the finished product.
2. To determinate and evaluate them, adherence to CGMP,s
Preparation and managing as USFDA inspection :-
Preparation:-
Conduct internal quality audits : 1 identifying potential problems 2 recommended connective actions 3 implements appropriate actions 4 conduct follow up audits.
Source of internal audits information: 1 Annual product reviews 2 batch failures 3 reprocess batches 4 returned goods 5 complaints related to product quality 6 recalled goods 7 stability failures.
FDA inspection Involves: 1. Direct observations of buildings, equipments, production, processes employer practices, records etc.
2. Systems approach like validation processes, equipment cleaning validations production and process controls established SOP’s documented activities method validations instrument handling and out of specification, master batch cards, complaint handling etc.
Internal audits: - Compare actual operations with DMF/NDA/ANDA and supplement commitments, commitments, company SOP’s FD&C Act requirement, CGMP requirements, FDA policy & guidelines etc.
Managing an FDA inspections:- 1. Don’t panic & be honest while accompanying with FDA auditor, 2. Select appropriate person, note taken technical experts to provide information and discuss records and procedures. 3. Responding to FDA auditor’s questions, If you don’t understand the question, ask for clarification & then answer. 4. Document retrieval for FDA inspections should be prompt & accurate. 5. Persons with authority to promise or make corrective actions are present.
What is FDA-483:- It is a written document of inspectional observations of FDA investigator during an inspection of a company.
Purpose of FDA-483:- 1. To assist firms inspected in complying with the laws and regulations entered for the FDA. 2. To provide notification to top management of significant findings. 3. All CGMP deficiencies will be reported on FDA-483.
Holding and Distribution:- 1. Ware housing procedures 2. FIFO system to be followed 3. There shall be a system to facilitate product recall 4. Storage of drug product under appropriate conditions.
Laboratory confronts: 1. Establishment, specifications, standards & sampling plans and other laboratory mechanisms. 2. All procedures &n specifications must be scientifically sound. 3. Review and approval of procedures by quality unit. 4. Deviations from established systems shall be recorded & justified. 5. Established procedures and schedules for all laboratory instruments. 6. Analytical methods shall be validated. 7. Out of specifications shall be recorded. 8. Every bath to be released after meeting the established specifications.
Stability testing: 1. Stability studies shall be used in determining appropriate storage conditions and expiration dates. 2. Written procedures shall be there and include sample size, test methods, storage conditions etc. 3. Stability samples shall be pack in stimulated market container.
Ic
GMP:-
GMP: Good manufacturing practices.
CGMP: Current Good manufacturing practices.
GMP Rules are about care and attention to ensure the things right and keep them right.
GMP Rules:
Be sure you have written correct instructions before any job is started.
Ensure that the correct materials are being used.
Always follow those instructions exactly.
Ensure that correct equipment being used and that is clean.
Prevent contamination and mixed.
Always guard against labeling errors, always use proper labeling
Always work accurately & precisely
Keep things clean & tidy
Find out the mistakes, errors & bad practices & report them immediately.
Make clean & accurate records of work done.
Applicability CGMP regulations:
If the person engages in only some operations subject to the regulation in this part that person need only comply with these regulations applicable to operations in which he or she is engaged.
GLP: Good Laboratory Practice:- Regulations relating to the conduct of toxicology studies, especially in the use of laboratory.
- Drug Master file.
Definition:- It is the document submitted voluntarily to regulatory authorities containing confidential information about process and facilities.
Requirements for DMF filing:-
1. Process: - a. Batch production Records b. In process controls c.
Intermediates
2. Facility address:
3. Production facilities: - a. Area b. Capacity.
4. Production Equipment:- a. GLR’S b. SSR’S c. Centrifuges d. Nutch, candy, leaf & Micro filters e. Driers like conevaccum drier tray drier f. Sifting equipments & bantom milling equipments etc.
5. Quality control: - a. In process control, b. Validation c. Specification and S T P’s of starting materials (Raw materials) intermediates, finished products etc.
6. Drug Description:- a. Chemical Abstract studies number b. Molecular formula c. Molecule structure d. Structural elucidation report etc.
7. Impurity profile:- a. process impurities b. Degradation impurities c. By products.
8. Analytical method validation:- HPLC, GC Analysis as per symphony.
9. Certificate of Analysis (COA) of reference standard, working standard and final product & their NMR & Mass.
10. List of major lab equipments :- a. Glass ware b. Stirrers c. Regulators d. Balances e. UV chambers f. Oven g. Autoclave h. MR apparatus i. Buchi Rotavapour systems k. high vacuum pumps & Diaphram pump etc.
11. Ware house facility Description:- Storage conditions
12. Organization chart:- Key persons Information
13. Production flow sheet or plant layout:-
14. Scheme process flow sheet & process Description:- Commercially availability of starting materials to total BPR.
15. Complaints filing:
16. Environment Assessment: SH&E package.
17. Annexcires BPR’s & Product labels:-
DMF Submission in Europe contains two parts.
Open part
Closed part
1. Open part:- (or) Applicant part:-
Nomenclature , structure and general properties like MR, solubility, Description & polymorphism.
Synthetic route chemical pathway.
Structural elucidation.
Impurity write up & impurity profile
Stability write up.
Control of active substance, final product specifications, COA and MOA, validation.
Reference standard : preparation & COA.
Container close system:- Closing & reading spec’s STP’s COA.
Manufacture:- Address.
2. Closed part or Aim restricted part:- API manufacture.
Address
Process validation or evaluation, process description & process control.
Specifications & STP’s of raw materials, intermediates, in process control & finished products.
DMF filing should be done by regulatory affairs.
DMF filing is compulsory for USFDA.
Regulatory affairs:- Responsibilities:
1. DMF filing \
2. Customer requirement
3. External affairs
4. As per regulatory requirements US, Europe & ROW
Drug master file is a reference source that provides confidential information not available to drug product manufacturers about the specifications, process and components used in the manufacturing, processing & packaging of drug meant for human use.
The submission of drug master file is not required by law & FDA regulation. A DMF is submitted slowly at the discretion of the holder. The information constricted in the DMF may be used to support on ‘IND, NDA & ANDA or another DMF or amendments and supplements to any of these.
A DMF is not a substitute for an IND, NDA, ANDA. It is not approved or disapproved. Technical contents of a DMF are revived only in connection with the review of an IND, NDA & ANDA.
Ib
US FDA Inspections.
Drug Inspections
Drug firms
New drugs
Manufacture of API and finished
Investigational new drugs
Product
Antibioties
Contract packages
Prescription drugs
Contract laboratories
Non perception drugs etc
Distributors, brokers & ware houses.
Types of Inspections: 1. GMP inspections 2. Pre-Approval inspections 3. Post –approval inspections 4. Other consumer complaints, recalls, drug quality reporting system etc.
Purpose of Inspections:
1. To ensure that production and control procedures include a reasonable predictions to ensure the identity, strength, quality & purity of the finished product.
2. To determinate and evaluate them, adherence to CGMP,s
Preparation and managing as USFDA inspection :-
Preparation:-
Conduct internal quality audits : 1 identifying potential problems 2 recommended connective actions 3 implements appropriate actions 4 conduct follow up audits.
Source of internal audits information: 1 Annual product reviews 2 batch failures 3 reprocess batches 4 returned goods 5 complaints related to product quality 6 recalled goods 7 stability failures.
FDA inspection Involves: 1. Direct observations of buildings, equipments, production, processes employer practices, records etc.
2. Systems approach like validation processes, equipment cleaning validations production and process controls established SOP’s documented activities method validations instrument handling and out of specification, master batch cards, complaint handling etc.
Internal audits: - Compare actual operations with DMF/NDA/ANDA and supplement commitments, commitments, company SOP’s FD&C Act requirement, CGMP requirements, FDA policy & guidelines etc.
Managing an FDA inspections:- 1. Don’t panic & be honest while accompanying with FDA auditor, 2. Select appropriate person, note taken technical experts to provide information and discuss records and procedures. 3. Responding to FDA auditor’s questions, If you don’t understand the question, ask for clarification & then answer. 4. Document retrieval for FDA inspections should be prompt & accurate. 5. Persons with authority to promise or make corrective actions are present.
What is FDA-483:- It is a written document of inspectional observations of FDA investigator during an inspection of a company.
Purpose of FDA-483:- 1. To assist firms inspected in complying with the laws and regulations entered for the FDA. 2. To provide notification to top management of significant findings. 3. All CGMP deficiencies will be reported on FDA-483.
Holding and Distribution:- 1. Ware housing procedures 2. FIFO system to be followed 3. There shall be a system to facilitate product recall 4. Storage of drug product under appropriate conditions.
Laboratory confronts: 1. Establishment, specifications, standards & sampling plans and other laboratory mechanisms. 2. All procedures &n specifications must be scientifically sound. 3. Review and approval of procedures by quality unit. 4. Deviations from established systems shall be recorded & justified. 5. Established procedures and schedules for all laboratory instruments. 6. Analytical methods shall be validated. 7. Out of specifications shall be recorded. 8. Every bath to be released after meeting the established specifications.
Stability testing: 1. Stability studies shall be used in determining appropriate storage conditions and expiration dates. 2. Written procedures shall be there and include sample size, test methods, storage conditions etc. 3. Stability samples shall be pack in stimulated market container.
Ic
GMP:-
GMP: Good manufacturing practices.
CGMP: Current Good manufacturing practices.
GMP Rules are about care and attention to ensure the things right and keep them right.
GMP Rules:
Be sure you have written correct instructions before any job is started.
Ensure that the correct materials are being used.
Always follow those instructions exactly.
Ensure that correct equipment being used and that is clean.
Prevent contamination and mixed.
Always guard against labeling errors, always use proper labeling
Always work accurately & precisely
Keep things clean & tidy
Find out the mistakes, errors & bad practices & report them immediately.
Make clean & accurate records of work done.
Applicability CGMP regulations:
If the person engages in only some operations subject to the regulation in this part that person need only comply with these regulations applicable to operations in which he or she is engaged.
GLP: Good Laboratory Practice:- Regulations relating to the conduct of toxicology studies, especially in the use of laboratory.
Sunday, July 20, 2008
HPLC Made to Measure: A Practical Handbook for Optimization
- HPLC Made to Measure: A Practical Handbook for OptimizationBy Stavros Kromidas
Publisher: Wiley-VCH - Number Of Pages: 786
- Publication Date: 2006-08-30
- ISBN-10 / ASIN: 352731377X ISBN-13 /
- EAN: 9783527313778
- Binding: Hardcover
The only topical HPLC book to focus on optimization, this volume addresses the needs of HPLC users who wish to constantly improve their methods, in particular in terms of throughput, accuracy and cost-effectiveness. This handbook features contributions from such bestselling authors as John W. Dolan, Michael McBrien, Veronika R. Meyer, Uwe D. Neue, Lloyd R. Snyder, and Klaus K. Unger, as well as from scientists working for major companies, including Agilent, AstraZeneca, Merck, Schering, Tosoh Biosep, VWR, and Waters. It covers essential aspects of optimization in general, optimization in different LC-modi, hyphenated techniques and computer-aided optimization. The whole is rounded off with a section of user reports. - http://mihd.net/vtgyp1k/
- http://rapidshare.com/files/109966139/i047.rar
ESTERIFICATIONEsterification: Methods, Reactions, and Applications
By Junzo Otera
Publisher: Wiley-VCH
Number Of Pages: 313
Publication Date: 2003-09-19
http://mihd.net/jai8hu
http://rapidshare.com/files/13751092/emraa.rar.html
Modern Derivitization Methods
Modern Derivatization Methods for Separation Science by Toshimasa Toyo'oka Publisher: Wiley Number Of Pages: 312 Publication Date: 1999-03-31 Sales Rank: 1109211 ISBN / ASIN: 0471983640 EAN: 9780471983644 Binding: Hardcover Manufacturer: Wiley Studio: Wiley Average Rating:
Total Reviews:
Total Reviews:
Includes new derivatizing reagents not covered in similar book by Blau andHalket (Wiley 1993) and not found in any other books to date.A field of increasing importance and significance in separation science.Concentrates on synthesis of derivatives for HPLC and CapillaryElectrophoresis, techniques of great interest in the pharmaceutical field.http://rapidshare.com/files/29301998/MDMSS.rar.html
Tuesday, July 15, 2008
Integrated Reaction and Separation Operations
Modelling and experimental validation
Modelling and experimental validation
- Publisher: Springer
- Number Of Pages: 366
- Publication Date: 2006-08-18
- ISBN-10 / ASIN: 3540301488
- ISBN-13 / EAN: 9783540301486
- Binding: Hardcover
Efficiency as well as economy of chemical processes can be increased by integration of reaction and separation in one unit. In this case e.g. reversible reaction may reach complete conversion. Well known examples are reactive distillations. But it has to be taken into account that process integration is not advantages in any case. An important parameter for process design is the degree of integration which varies between homogeneous integration, partial integration with distributed functionalities and non-integrated sequential processes.
The book gives deep insights into the overall evaluation of integrated processes as well as development of methods for a systematic design and optimisation of integrated reaction and separation processes.. Potentials and the technical as well as economic limitations for process integration have been identified. The book covers several case studies of reactive distillation, reactive extraction, reactive gas-adsorption and chromatographic reactors which have been investigated from the modelling and experimental point of view. Based on validated models process simulation was used to optimize these processes. Following the concept of integrated process design approaches have been developed for model predictive control and process optimisation during production. Another new and very important focus of the book is systematic synthesis of integrated processes.
Based on the investigation of processes mentioned above as well as further process simulations heuristic rule and short cut method have been developed which are used to evaluate the advantages and disadvantages of a certain process integration and to develop a favourable process design.
The book presents the latest developments in simulation of integrated processes as well as new methods of process synthesis and process control. It shows also the details of experimental approaches for model validation, determining of model parameters and measurement techniques. The combination of sophisticated modelling, optimisation methods and experimental results has not ben published up to now. Therefore on the book addresses readers from industry as well as academic research
http://rapidshare.com/files/11947275...3540301488.rar
Synthetic Chemistry Books
Radicals in Organic Synthesis
- Publisher: Wiley-VCH
- Number Of Pages: 1158
- Publication Date: 2001-05-25
- ISBN-10 / ASIN: 3527301607
- ISBN-13 / EAN: 9783527301607
- Binding: Hardcover
Product Description:
Over the past few years, radical chemistry has witnessed a rapid development, with the result, for example, that new methods for producing radicals now allow the targeted use of these reactive intermediate stages in organic synthesis. This two-volume work is an account of the progress being made.
The first volume covers basic methodologies for successfully carrying out radical reactions, complete with a detailed discussion of the effectiveness and versatility of the individual methods. Further, the first volume also treats the characteristics of radicals, where such information is necessary for the successful planning of synthesis.
The second volume concentrates on applications for radicals in synthesis. Of particular use to those working in research are the numerous comparisons to "classic" methods of synthesis, carefully collected from the editors' and authors' many years of experience in the field.
The vast amount of information contained in this work makes it an essential reference for every organic chemist working in industry and academia
http://mihd.net/wl3rjsp
The first volume covers basic methodologies for successfully carrying out radical reactions, complete with a detailed discussion of the effectiveness and versatility of the individual methods. Further, the first volume also treats the characteristics of radicals, where such information is necessary for the successful planning of synthesis.
The second volume concentrates on applications for radicals in synthesis. Of particular use to those working in research are the numerous comparisons to "classic" methods of synthesis, carefully collected from the editors' and authors' many years of experience in the field.
The vast amount of information contained in this work makes it an essential reference for every organic chemist working in industry and academia
http://mihd.net/wl3rjsp
Subscribe to:
Posts (Atom)
Posts
