| 查看: 1410 | 回复: 20 | |||
| 当前主题已经存档。 | |||
[交流]
【求助】关于报仿制药结构确证的问题（急求）
|
|||
| 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） |
回复此楼» 猜你喜欢
2026CSC博士，有机化学，有机方法学，不对称催化
已经有0人回复
-
巴黎萨克雷大学与国家留学基金委合作博士研究生项目-脂质纳米药物/生物材料/多酚递送
已经有10人回复
-
药理学论文润色/翻译怎么收费?
已经有178人回复
-
2026博士申请-药物化学方向（小分子化合物合成）
已经有4人回复
-
大肠杆菌临床分离菌株ETEC菌株求购
已经有5人回复
-
钯碳氢气还原脱cbz产物伯胺出现甲基化。
已经有2人回复
-
求助《化工原理》第四版 柴诚敬、贾绍义 课件
已经有0人回复
-
酯类化合物柱层析极性较大，使用醇类溶剂，怎么避免酯交换
已经有2人回复
-
求助骆广生微化工技术书籍
已经有1人回复
-
求助冯连芳、张才亮的《聚合过程强化技术》
已经有0人回复
2楼2009-09-28 09:54:39
hexinhua0920
木虫 (正式写手)
- 应助: 32 (小学生)
- 金币: 4053.5
- 散金: 160
- 红花: 5
- 帖子: 898
- 在线: 419.1小时
- 虫号: 235556
- 注册: 2006-04-01
- 性别: GG
- 专业: 药物设计与药物信息
3楼2009-09-28 10:00:11
4楼2009-09-28 10:11:44
user53900
木虫 (正式写手)
知易行难，实验的真谛
- 应助: 26 (小学生)
- 贵宾: 0.01
- 金币: 3116.5
- 红花: 1
- 帖子: 811
- 在线: 89.6小时
- 虫号: 823186
- 注册: 2009-08-06
- 性别: GG
- 专业: 药物分析
元素分析：结果数据表和说明 5楼2009-09-28 14:11:37
llb1978
金虫 (正式写手)
- 应助: 2 (幼儿园)
- 金币: 1364.2
- 红花: 2
- 帖子: 462
- 在线: 24.7小时
- 虫号: 92998
- 注册: 2005-09-12
- 性别: GG
- 专业: 药物学
★ ★ ★
songdx(金币+1,VIP+0): 9-29 12:48
duandian123(金币+2,VIP+0):谢谢参与！ 10-9 13:48
songdx(金币+1,VIP+0): 9-29 12:48
duandian123(金币+2,VIP+0):谢谢参与！ 10-9 13:48
|
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
木虫 (小有名气)
- 应助: 0 (幼儿园)
- 金币: 2317.6
- 散金: 16
- 帖子: 185
- 在线: 13.9小时
- 虫号: 819840
- 注册: 2009-08-01
- 性别: MM
- 专业: 药物学其他科学问题
7楼2009-10-09 13:44:02
yyleyy
金虫 (正式写手)
- 应助: 0 (幼儿园)
- 金币: 1403.6
- 散金: 382
- 红花: 1
- 帖子: 494
- 在线: 24.5小时
- 虫号: 231655
- 注册: 2006-03-27
- 性别: GG
- 专业: 污染控制化学
8楼2009-10-10 08:50:07
huiyu1001
铁杆木虫 (小有名气)
- 应助: 0 (幼儿园)
- 金币: 8259
- 帖子: 222
- 在线: 136.1小时
- 虫号: 615235
- 注册: 2008-09-29
- 性别: GG
- 专业: 会计学
9楼2009-10-10 09:26:53
10楼2009-10-19 11:14:44