USP 《233》ELEMENTAL IMPURITIES—PROCEDURES 中英对照 〈233〉 ELEMENTAL IMPURITIES—PROCEDURES 元素杂质-程序 INTRODUCTION 介绍 This chapter describes two analytical procedures (Procedures 1 and 2) for the evaluation of the levels of the elemental impurities. The chapter also describes criteria for ...
1、ELEMENTAL IMPURITIESLIMITS 元素杂质限度INTRODUCTION 介绍This general chapter specifies limits for the amounts of elemental impurities in drug products. Elemental impurities include catalysts and environmental contaminants that may be present in drug substances, excipients, or drug products. These ...
<232>ELEMENTAL IMPURITIES—LIMITS元素杂质—限度 INTRODUCTION介绍 This general chapter specifies limits for the amounts of elemental impurities in drug products. Elemental impurities include catalysts and environmental contaminants that may be present in drug substances, excipients, or drug products. These ...
233? Elemental Impurities—Procedures / Chemical Tests Second Supplement to USP 35–NF 30 Procedure 1: ICP-AES Standardization solution 1: 2J of the Target Element(s) in a Matched Matrix Standardization solution 2: 0.5J of the Target Element(s) in a Matched Matrix Sample stock solution: ...
itmaybepossibletoshowviaaprocedurethatquantifiesthedifferentformsthattheinorganic formmeetsthespecification. 砷限度是基于无机(大多是有毒的)形式。假定物料中含有的砷均为无机形式,则可以采用总砷 测试方式进行检测,如果采用总砷量检测结果显示超出限度,也可以对不同砷的存在方式进行定 ...
United States Pharmacopeia (USP) chapters <232> Elemental Impurities-Limits and <233> Elemental Impurities-Procedures specify limits and procedures for elemental impurities in drug products. To reduce risks associated with potentially toxic and harmful elemental impurities, these must be identified and ...
<232>ELEMENTAL IMPURITIES—LIMITS元素杂质—限度 INTRODUCTION介绍 This general chapter specifies limits for the amounts of elemental impurities in drug products. Elemental impurities include catalysts and environmental contaminants that may be present in drug substances, excipients, or drug products. These ...
USPELEMENTALIMPURITIES元素杂质限度中英文汇总.pdf,232ELEMENTAL IMPURITIES — LIMITS 元素杂质—限度 INTRODUCTION 介绍 This general chapter specifies limits for the amounts of elemental impurities in drug products. Elemental impurities include catalysts and
内容提示: <232>ELEMENTAL IMPURITIES —LIMITS 元素杂质—限度INTRODUCTION 介绍This general chapter specifies limits for the amounts of elemental impurities in drug products. Elemental impurities include catalysts and environmental contaminants that may be present in drug substances, excipients, or drug ...
USP36 232 ELEMENTAL IMPURITIES 元素杂质--限度 (中英文).doc,232ELEMENTAL IMPURITIES—LIMITS 元素杂质—限度 INTRODUCTION 介绍 This general chapter specifies limits for the amounts of elemental impurities in drug products. Elemental impurities include catal