revision of General Chapter Heavy Metals <231>. As drafted by this Ad Hoc Advisory Panel and revised by the Expert Committee, the proposed revision specifies that the level of each inorganic impurity should not exceed the limit defined in Table 1 or otherwise specified in the individual ...
<905>UNIFORMITY OF DOSAGE UNITS(Harmonized Chapter, Official April 1,2006)……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>WATER DETERMINATION……2785水测定法 <941>X-RAY DIFFRACTION……2788X光衍射 General Information通用信息 <1010>ANALYTICAL DATA—INTERPRETATION AND ...
《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...
(Harmonized Chapter, Official April 1,2006)2780制剂单位的含量均匀度(协调的章节2006.4.1)911VISCOSITY2785粘度921WATER DETERMINATION2785水测定法941X-RAY DIFFRACTION2788X光衍射General Information通用信息1010ANALYTICAL DATAINTERPRETATION AND TREATMENT2790分析数据解释与处理1015AUTOMATED RADIOCHEMICAL SYNTHESIS APPARATUS...
This chapter applies, in whole or in part, when referenced in a drug product monograph (see General Notices, 3.10 Applica- bility of Standards). (RB 1-May-2016) Official from null Copyright (c) 2017 The United States Pharmacopeial Convention. All rights reserved. Accessed from by brunswick20...
这些测试通常按照 USP 的 General Chapter <88>进行,该章节详细描述了生物相容性测试的标准和方法。 USP Class VI 的应用 Class VI 级别的材料被广泛用于: 医疗和制药行业 生物制药制造商的工艺设备 医疗设施中作为泵和流体传输的组件 一次性使用过程组件,如管道、一次性袋子、塑料连接器、硅胶制品 ...
《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...
DocumentType:GENERALCHAPTER DOI:/10.31003/USPNF_M16255_02_01 印刷日期:2023年7月31日星期一,晚上10:07:52(美国东部时间) 作者:AlbertZhao 不公开状态 尚未正式公布:2023年8月1日 公布公开日期:2023年12月1日 DOIRef:89bb2 文档身份证:GUID-06A07B0B-3865-40B6-A4C9-D77B5DAD0B3B2en-US 文件类型:一...
USP官方释义2Reference Changes represent an example of changes made via Compendial Notice. Sometimes it is necessary for USP to modify general chapter titles, section titles, appendix titles, reference to external resources, or similar text that may be referenced in standards throughout the USP–NF....
1. Inductively coupled plasma–atomic (optical) emission spectrometer. 2. Inductively coupled plasma–mass spectrometer. In addition, a closed-vessel microwave digestion system may be required for the preparation of test materials (see Figure 1). General Chapter on Inorganic Impurities: Heavy Me...