验证原则见general chapterValidation of Compendial Procedures 1225 .验证内容(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。元素杂质检测法的验证要求见下文。一旦本章说法某处跟Validation of Compendial Procedures 1225 中的不一致,以本章提到的参数和接受标准优先。任何替代分析方法经验证,且满足接受标准,...
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。
USP-232中英对照-USP-38-NF-33.docx,Second Supplement to USP 38-NF 33 Chemical Tests / 232 Elemental Impurities—Limits) 注:背景字体表示最新变化,232执行日期2018.01.01 Page 232ELEMENTAL IMPURITIES—LIMITS INTRODUCTION This general chapter specifies limits
USP-232中英对照-USP-38-NF-33<232>ELEMENTAL IMPURITIES—LIMITS INTRODUCTION This general chapter specifies limits for the amounts of elemental impurities in drug products. Elemental impurities include catalysts andenvironmental contaminantsthat may be present in drug substances, excipients, or drug ...
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 Chapter <231> be omitted once General Chapters <232> and <2232> become applicable? 是否一旦通论<232>和<2232>开始应用,通论<231>就...
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 ...
USP 232中英对照PF40(2)<232>ELEMENTAL IMPURITIES-LIMITS INTRODUCTION This general chapter specifies limits for the amounts of elemental impurities in drug products. Elemental impurities include catalysts andenvironmental contaminantsthat may be present in drug substances, excipients, or drug products. ...
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 Notices 6 30 替代方法必须经验证可靠 等价于药典方法 验证原则见 general chapter Validation of Compendial Procedures 1225 验证内容 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 元素杂质检测法的验 证要求见下文 一旦本章说法某处跟 Validation of Compendial Procedures 1225 中的不一致 以本...