ingredients according to draft USP general chapters <232>/<233>, Agilent publication, 5990-9365EN (2011). .agilent/chem/cn 安捷伦对本资料中可能存在的错误或由于提供、展示或使用本资料所造成的间接损失不承担 任何责任。 本资料中的信息、说明和指标如有变更,恕不另行通知。
General Chapter Kahkashan Zaidi, Ph.D. Senior Scientific Liaison 1-301-816-8269 (GCCA2010) General Chapters - Chemical Analysis USP36–NF31Page 151 Pharmacopeial Forum: Volume No. 37(3) 233 元素杂质检查法 Change to read: 介绍 本章将介绍两种元素杂质检查法(Procedures 1and2),也描述了其他可...
GeneralChapterKahkashanZaidi,(GCCA2010)GeneralChapters .-ChemicalAnalysis SeniorScientific Liaison 1-301-816-8269 USP36NF31Page151 PharmacopeialForum:(3) '233;元素杂质检查法 Changetoread: 介绍 本章将介绍两种元素杂质检查法(Procedures1and2),也描述了其他可替代分析方法的接受标准。其他满足这里提到的验证要...
general chapter Validation of Compendial Procedures 1225 . 验证内 232 容(确保替代分析方法可用)取决于是限度检查法还是含量测定方法。元素杂 233 质检测法的验证要求见下文。一旦本章说法某处跟Validation of Compendial 234 Procedures 1225 中的不一致, 以本章提到的参数和接受标准优先。任何替 235 ...
The chapter also describes criteria for acceptable alternative procedures. Alternative procedures that meet the validation re-quirements herein may be used in accordance with General Notices and Requirements 6.30, Alternative and Harmonized Meth-ods and Procedures . Information on the Requirements for ...
General Chapter <233> already is applicable in certain cases through reference in currently official monographs (see question 1). 答:通论<233>会在通论<232>和<2232>中被引用,因此不必要单独在通则5.60.30中引用。通论<233>已经通过在现行生效的各论中通过引用开始使用(参见问#1). 7. Will General Chapt...
1 ? This dietary supplement chapter is still under revision and will appear online in PF 38(3) [May–June 2012]. Auxiliary Information— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee General Chapter Kahkashan Zaidi, Ph.D. Senior ...
2013最新USP232元素杂质一限度介绍本通则明确了药品中各元素杂质的限度。元素杂质包括催化剂环境污染物,可能存在于原料药赋形剂制剂中。这些杂质或自然产生,或有意添加,或由于不注意而引入例如,与处理设备相互作用。当知道元素杂质存在,或有意
General Chapter Kahkashan Zaidi Ph D Senior Scientific Liaison 1 301 816 8269 GCCA2010 General Chapters Chemical Analysis USP36 NF31 Page 151 Pharmacopeial Forum Volume No 37 3 233 元素杂质检查法元素杂质检查法 Change to read 介绍介绍 本章将介绍两种元素杂质检查法 Procedures 1 and 2 也描述了...
General Chapter <232> Elemental Impurities – Limits: 2nd Supplement of USP 35-NF 30. 2. General Chapter <233> Elemental Impurities – Procedures: 2nd Supplement of USP 35-NF 30. 3. "Implementation of USP Ne...