Submissions to the USP should make note of the requirements under the System Suitability section in the general test chapter Chromatography 621. 系统适用性 如果测试易受测试条件变化的影响,应当对方法进行合理控制或是指明注意事项。评估耐用性就是确立一系列系统适用性参数,以确保不论何时使用,均可维持分析...
Submissions to the USP should make note of the requirements under the System Suitability section in the general test chapter Chromatography 621. 系统适用性 如果测试易受测试条件变化的影响,应当对方法进行合理控制或是指明注意事项。评估耐用性就是确立一系列系统适用性参数,以确保不论何时使用,均可维持分析...
The added section on "Life cycle Management" ingeneral chapter <1225> states that "once ...
认识到USP和NF标准的法律地位，因此，提议采纳新的或更改过的药典分析规程时，以充分的实验室数据作为支持，以记录其有效性，成为基本要求。The text of this information chapter harmonizes, to the extent possible, with the Tripartite International Conference on Harmonization (ICH) documents Validation of ...
1、usp1225药典规程的验证(中英文对照) 1225validation of compendial procedures 药典规程的验证 test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. according to section 501 of the federal food, drug, and cosmetic act, assays and ...
USP39 General Chapter <1225> Validation of Compendial Procedures
This assessment is madeusing a preapproved transfer orvalidation protocol that provides the detailsof the procedure, the samples tobe used, and the predetermined acceptancecriteria. General chapter Validationof Compendial Procedures 1225 providesuseful guidance about whichcharacteristics are appropriate for ...
美国药典35版USP 1225 VALIDATION OF COMPENDIAL PROCEDURES Accessed from 46.201.206.156 by boyo3 on Wed May 16 18:53:54 EDT 2012 USP 35 General Information / 〈1225〉 Validation of Compendial Procedures 877 ELEMENTS RECOMMENDED FOR THE It is recommended that expired, aged, or spiked samples TR...
<905>UNIFORMITYOFDOSAGEUNITS(HarmonizedChapter,OfficialApril1,2006)……2780制剂单 位的含量均匀度(协调的章节2006.4.1) <911>VISCOSITY……2785粘度 <921>WATERDETERMINATION……2785水测定法 <941>X-RAYDIFFRACTION……2788X光衍射 GeneralInformation通用信息 ...
《美国药典-国家处方集》(USP-NF)中的通用检测方法收录在通则(General Chapter)中,所有的通则都是强制执行的吗? 回答: 在USP37-NF32 第二增补本的凡例(General Notice)中“2.OFFICIAL STATUS AND LEGAL RECOGNITION”项下有如下规定: “2.10. Official Text Official te...