Author: 医薬品医療機器レギュラトリーサイエンス財団
Publisher:
ISBN: 9784840813716
Category :
Languages : en
Pages : 2630

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Book Description
The Japanese Pharmacopoeia 17th edition (JP XVII) English translation is fully endorsed by the society of the Japanese Pharmacopoeia. It defines the specifications, criteria and standard test methods necessary to properly ensure the quality of medicines in Japan. The Japanese language edition was effective from 1st April 2016. Key features: -General Notices, General Rules for Crude Drugs, General Rules for Preparations: revised and expanded. -Official monographs: 76 new monographs and 473 revised monographs. -General tests, processes and apparatus: 23 new standards and 10 revised standards. -Infrared reference spectra: 21 new spectra and 2 revised spectra. -Ultraviolet-visible reference spectra: 14 new spectra and 2 revised spectra This title supersedes the Japanese Pharmacopoeia 16th edition (ISBN 9784840812023), as well as JP 16th edition Supplement I (ISBN 9784840812382) and JP 16th edition Supplement II (ISBN 9784840812832). The JP aims to: 1.Include all drugs which are important from the viewpoint of health care and medical treatment. 2.Make qualitative improvement by introducing the latest science and technology. 3.Promote internationalization. Make prompt partial revision as necessary and facilitating smooth administrative operation. Ensure transparency regarding the revision, and disseminating the JP to the public.

Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1116

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Author:
Publisher:
ISBN:
Category : Pharmacopoeias
Languages : en
Pages : 482

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Author: Nihon Yakugakkai
Publisher:
ISBN:
Category : Pharmacopoeias
Languages : en
Pages : 554

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Author: The Stationery Office
Publisher: Stationery Office Books (TSO)
ISBN: 9780113230204
Category : Business & Economics
Languages : en
Pages : 0

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Book Description
Updated annually, the British Pharmacopoeia is the only comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products. It includes almost 4,000 monographs which are legally enforced by the Human Medicines Regulations 2012.

Author: Robert Thomas
Publisher: CRC Press
ISBN: 1351984403
Category : Medical
Languages : en
Pages : 503

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Book Description
Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters , , and , together with Q3D, Step 4 guidelines for elemental impurities, drafted by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), a consortium of global pharmaceutical associations, including the European Pharmacopeia (Ph.Eur.), the Japanese Pharmacopeia (JP) and the USP. This book provides a complete guide to the analytical methodology, instrumental techniques and sample preparation procedures used for measuring elemental impurities in pharmaceutical and nutraceutical materials. It offers readers the tools to better understand plasma spectrochemistry to optimize detection capability for the full suite of elemental PDE (Permitted Daily Exposure) levels in the various drug delivery categories. Other relevant information covered in the book includes: The complete guide to measuring elemental impurities in pharmaceutical and nutraceutical materials. Covers heavy metals testing in the pharmaceutical industry from an historical perspective. Gives an overview of current USP Chapters and and ICH Q3D Step 4 Guidelines. Explains the purpose of validation protocols used in Chapter , including how J-values are calculated Describes fundamental principles and practical capabilities of ICP-MS and ICP-OES. Offers guidelines about the optimum strategy for risk assessment Provides tips on how best to prepare and present your data for regulatory inspection. An indispensable resource, the fundamental principles and practical benefits of ICP-OES and ICP-MS are covered in a reader-friendly format that a novice, who is carrying out elemental impurities testing in the pharmaceutical and nutraceutical communities, will find easy to understand.

Author: British Pharmacopoeia Commission
Publisher:
ISBN: 9780113230891
Category :
Languages : en
Pages :

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Book Description
Updated annually, the BP is the official, authoritative collection of standards for UK medicinal substances for human and veterinary use. The BP 2022 includes almost 4,000 monographs. All monographs and requirements of the European Pharmacopoeia are also reproduced in the BP, making it an essential reference for students, lecturers and researchers. The online product provides subscribers with access to the British pharmacopoeia 2022, British pharmacopoeia (veterinary) 2022 and the current edition and supplements of Britsh approved names. Concurrent access to the 2014 onwards is also available

Author: William Martindale
Publisher:
ISBN:
Category : Pharmacopoeias
Languages : en
Pages : 1914

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Author:
Publisher:
ISBN: 9788193721421
Category :
Languages : en
Pages :

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Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 552

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Book Description