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...
established general procedure with a new product or raw material (see below in Data Elements Required for Validation). The ICH documents give guidance on the necessity for revalidation in the following circumstances: changes in the synthesis of the drug substance; changes in the ...
Submissions to the USP should make note of the requirements under the System Suitability section in the general test chapter Chromatography <621>. 系统适用性测试基于这个概念,即这些设备、电子仪器、分析操作、供试样品构成了一个完整系统,此系统可以作为整体进行评估。为某个特定规程设定的系统适用性测试参数...
The added section on "Life cycle Management" ingeneral chapter <1225> states that "once ...
procedures described in this document are listed in Table 1. Because opinions may differ with respect to terminology and use, each of the performance characteristics is defined in the next section of this chapter, along with a delineation of a typical method or methods by which it may be ...
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 ...
supported by sucient laboratory data to document their validity. The text of this information chapter harmonizes, to the extent possible, with the International Council for Harmonisation (ICH) tripartite guideline Validation of Analytical Procedures and the Methodology extension text, which are concerned...
《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...
USP39 General Chapter <1225> Validation of Compendial Procedures