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【求助】关于报仿制药结构确证的问题（急求）
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| 本人现在做一仿制药（手性药），现有药检所提供的对照品，请问我做结构确证需做哪些项目？（哪些项目样品和对照品均做，哪些项目只需样品做） |
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2楼2009-09-28 09:54:39
hexinhua0920
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注意：晶型研究也很重要的。 顺便分享一下多晶型的FDA指南和几本英文经典书籍。 ANDAs: Pharmaceutical Solid Polymorphism Chemistry, Manufacturing, and Controls Information http://www.fda.gov/downloads/Dru ... ances/ucm072866.pdf Polymorphism in the Pharmaceutical Industry-Wiley 2006 Polymorphism: in the Pharmaceutical Industry By Rolf Hilfiker Publisher: Wiley-VCH Number Of Pages: 433 Publication Date: 2006-04-17 ISBN-10 / ASIN: 3527311467 ISBN-13 / EAN: 9783527311460 Binding: Hardcover Edited by one of the leading experts in the field, this handbook emphasizes why solid-state issues are important, which approaches should be taken to avoid problems and exploit the opportunities offered by solid state properties in the pharmaceutical and agricultural industries. With its practical approach, this is at once a guideline for development chemists just entering the field as well as a high-quality source of reference material for specialists in the pharmaceutical and chemical industry, structural chemists, physicochemists, crystallographers, inorganic chemists, and patent departments. http://www.filefactory.com/file/deef89/ http://rapidshare.com/files/94365103/New_Folder__2_.rar http://www.namipan.com/d/Polymor ... cd7a8c25c57c3464100 polymorphism_pharmaceutical_solids_1999 Brittain ed. (1999) Presents a comprehensive examination of polymorphic behavior in pharmaceutical development-demonstrating with clear, practical examples how to navigate complicated crystal structures. Edited by the recipient of the American Association of Pharmaceutical Scientists' 1998 Research Achievement Award in Analysis and Pharmaceutical Quality. http://rapidshare.com/files/12436523/pphs.rar.html http://www.namipan.com/d/polymor ... 8f37ece4ae1461c4e00 《Crystallization_Technology_Handbook》 文件类型：pdf Crystallization Technology Handbook CRC Press | ISBN: 0824705289 | 2001-05-08 (2nd Edition) | PDF | 840 pages | 6.97 Mb | RS This handbook seeks to facilitate the selection, design and operation of large-scale industrial crystallizers that process crystals with the proper size distribution, shape and purity sought - including cooling, evaporation, drowning-out reaction, melt, and related crystallization techniques. This new edition offers new results on direct-contact cooling crystallization. It lists the properties of over 170 organic and inorganic crystallization systems. An up-to-date review of the engineering science of crystallization, featuring well-organized and clear guidelines for the building, running and optimization of crystallizer operations. Offers new results on direct-contact cooling crystallization, measures of solubility and supersaturation, surface nucleation on crystals, and other advanced topics. download: http://rapidshare.com/files/4992 ... nology_Handbook.pdf http://d.namipan.com/d/Crystalli ... 0c4a2ab962e3ba06f00 |
6楼2009-09-29 09:36:22
kuandailin
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7楼2009-10-09 13:44:02
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huiyu1001
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