膳食补充剂及其成分在《膳食补充剂元素污染物2232》中已有说明。 SPECIATION杂质形态 The determination of the oxidation state, organic complex, or combination is termed speciation. Each of the elemental impurities has the potential to be present in differing oxidation or complexation states. However, ...
膳食补充剂及其成分在《膳食补充剂元素污染物2232》中已有说明。 SPECIATION杂质形态 The determination of the oxidation state, organic complex, or combination is termed speciation. Each of the elemental impurities has the potential to be present in differing oxidation or complexation states. However, ...
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 ...
ElementalContaminantsinDietarySupplements2232.1 本章中指出的限度不适用于仅供兽用品种和传统疫苗。膳食补充剂及其成分在《膳食补充剂元素 污染物2232》中已有说明。 SPECIATION杂质形态 Thedeterminationoftheoxidationstate,organiccomplex,orcombinationistermedspeciation. Eachoftheelementalimpuritieshasthepotentialtobepresentin...
膳食补充剂及其成分在膳食补充剂元素污染物2232中已有说明。SPECIATION 杂 7、质形态The determination of the oxidation state, organic complex, or combination is termed speciation. Each of the elemental impurities has the potential to be present in differing oxidation or complexation states. However, ...
目标限度或目标浓度:即元素杂质的可接受值。超过目标限度就是指测试样品杂质含量超过可接受值。判定是否合乎规范见于别的章节。[注意—将本章内容应用于Elemental Impurities—Limits 232 和Elemental Contaminants in Dietary Supplements 2232 ,1时,目标限度近似为日剂量PDE值除以日最大剂量(对于 232 中的药品分析)或者...
contaminants that may be present in drug substances, excipients, or drug products. These impuri-ties may occur naturally, be added intentionally, or be introduced inadvertently (e.g., by interactions with processing equip-ment and the container closure system). When elemental impurities are known ...
USP34通则2232 膳食补充剂元素杂质规定 下载积分: 100 内容提示: Pharmacopeial ForumVol. 36(1) [Jan.–Feb. 2010]LIMITS OF ELEMENTAL CONTAMINANTS1The levels of elemental contaminants should be restric-ted as shown in Table 1. Elemental Limits unless otherwiseB RIEFINGh2232i Elemental Contaminants in...
<2232> Elemental Contaminants in Dietary Supplements 关于USP通论<232>元素杂质—限度,<233>元素杂质—方法 和<2232>膳食补充剂中的元素污染实施的常见问题 Version5:March27,2015 版本号5:2015年3月27日 1. How will General Chapters<232> Elemental Impurities—Limits and <2232> Elemental Contaminants in Di...
233 Elemental Impurities Procedures(元素杂质规程) USP40 热度: 《美国药典》新通则232和233元素杂质控制新标准和方法介绍及其对医药界的影响 热度: 最新usp232-233原文 热度: 摘要 美国药典(USP)正在开发药品及其成分中有机杂质的新检测方法。人们普遍认 ...